Thoracic Surgery
Conditions
Keywords
Thoracic surgery
Brief summary
The purpose of this research is to compare a single shot long acting local anesthetic to catheter infusion of local anesthetic in patients undergoing video assisted thoracoscopic (VAT) surgery.
Detailed description
The purpose of this research is to compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% bolus followed by 0.2% infusion of local anesthetic using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.
Interventions
Single shot for erector spinae block
DRUGRopivacaine (0.5% bolus followed by 0.2% infusion)
Continuous catheter infusion for erector spinae plane block
Sponsors
Poovendran Saththasivam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% followed by 0.2% infusion using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects who are age \> 18, undergoing video thoracoscopic surgery and following Guthrie Robert Packer Hospital's Enhanced Recovery After Surgery (ERAS) protocol for Thoracic Surgery.
Exclusion criteria
* weight \< 50 kg, pregnant subjects, * left ventricular ejection fraction \< 30%, * history of drug or narcotic abuse, * history of allergic to amide local anesthetic, * presence of contraindication for erector spinae plane block (local skin infection, sepsis, severe coagulopathy) * unable to provide consent, * unable to use pain rating scales as demonstrated by verbal feedback * preoperative chronic pain on narcotics, * history of renal insufficiency ( Creatinine \> 1.5 mg/dl), * preoperative mild liver impairment ( i.e. AST/ALT above 1.5 times the upper normal limit)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative | 0-4 hours post operative | Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative | 4-8 hours post operative | Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative | 8-12 hours post operative | Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative | 12-24 hours post operative | Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative | 2 days post operative | Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale 48-72 Hours Post-operative | 3 days post-operative | Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative | 0-4 hours post-operative | Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative | 4-8 hours post-operative | Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative | 8-12 hours post-operative | Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative | 12-24 hours post-operative | Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative | 24-48 hours post-operative | Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
| Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative | 48-72 hours post-operative | Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative | 48-72 hours post-operative | Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points. |
| Gabapentin Consumption in Milligrams 0-4 Hours Post-operative | 0-4 hours post-operative | Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points. |
| Gabapentin Consumption in Milligrams 4-8 Hours Post-operative | 4-8 hours post-operative | Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points. |
| Gabapentin Consumption in Milligrams 8-16 Hours Post-operative | 8-16 hours post-operative | Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points. |
| Gabapentin Consumption in Milligrams 16-24 Hours Post-operative | 16-24 hours post-operative | Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points. |
| Gabapentin Consumption in Milligrams 24-48 Hours Post-operative | 24-48 hours post-operative | Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points. |
| Gabapentin Consumption in Milligrams 48-72 Hours Post-operative | 48-72 hours post-operative | Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points. |
| Ketorolac Consumption in Milligrams 0-4 Hours Post-operative | 0-4 hours post-operative | The ketorolac use in milligrams will be compared in each group at different time points. |
| Ketorolac Consumption in Milligrams 4-8 Hours Post-operative | 4-8 hours post-operative | The ketorolac use in milligrams will be compared in each group at different time points. |
| Ketorolac Consumption in Milligrams 8-16 Hours Post-operative | 8-16 hours post-operative | The ketorolac use in milligrams will be compared in each group at different time points. |
| Ketorolac Consumption in Milligrams 16-24 Hours Post-operative | 16-24 hours post-operative | The ketorolac use in milligrams will be compared in each group at different time points. |
| Ketorolac Consumption in Milligrams 24-48 Hours Post-operative | 24-48 hours post-operative. | The ketorolac use in milligrams will be compared in each group at different time points. |
| Ketorolac Consumption in Milligrams 48-72 Hours Post-operative | 48-72 hours post-operative | Ketorolac is a pain medication that is not an opioid. The ketorolac use in milligrams will be compared in each group at different time points. |
| Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative | 12-24 hours post-operative | A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome. |
| Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative | 24-48 hours post-operative | A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome. |
| Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative | 48-72 hours post-operative | A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome. |
| Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative | 0-4 hours post-operative | Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative | 4-8 hours post-operative | Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 4 to 8 hours post-operative). A negative number reflects reduced volume of air. |
| Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative | 8-12 hours post-operative | Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 8 to 12 hours post-operative). A negative number reflects reduced volume of air. |
| Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative | 12-24 hours post-operative | Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 12 to 24 hours post-operative). A negative number reflects reduced volume of air. |
| Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative | 24-48 hours post-operative | Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 24 to 48 hours post-operative). A negative number reflects reduced volume of air. |
| Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative | 48-72 hours post-operative | Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 48 to 72 hours post-operative). A negative number reflects reduced volume of air. |
| Length of Hospital Stay | From date of admission until date of discharge, an average of 72 hours | Number of hours from admission to discharge |
| Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative | 0-4 hours post-operative | Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 0 to 4 hours post-operative). A negative number reflects reduced volume of air. |
| Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative | 4-8 hours post-operative | Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative | 8-16 hours post-operative | Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative | 16-24 hours post-operative | Post-operative opioid consumption in morphine equivalent dose (MED to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative | 24-48 hours post-operative | Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative | 48-72 hours post-operative | Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Total Intraoperative Opioid Consumption in Morphine Equivalent Dose | From start of surgery to end of surgery, an average of 2-3 hours | Total opioids administered in morphine equivalent dose (MED) in the operating room during the surgery. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency. |
| Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative | 0-4 hours post-operative | Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points. |
| Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative | 4-8 hours post-operative | Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points. |
| Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative | 8-16 hours post-operative | Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points. |
| Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative | 16-24 hours post-operative | Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points. |
| Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative | 24-48 hours post-operative | Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Liposomal Bupivacaine (EXPAREL®)/Bupivacaine: Single shot for erector spinae block | 17 |
| Continuous Catheter Infusion Ropivacaine Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Ropivacaine (0.5% bolus followed by 0.2% infusion): Continuous catheter infusion for erector spinae plane block | 19 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Other | 2 | 1 |
| Overall Study | Provider unavailable | 2 | 1 |
| Overall Study | Thoracotomy conversion | 1 | 1 |
Baseline characteristics
| Characteristic | Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Continuous Catheter Infusion Ropivacaine | Total |
|---|---|---|---|
| Age, Continuous | 65.53 years STANDARD_DEVIATION 9.45 | 65.21 years STANDARD_DEVIATION 12.91 | 65.36 years STANDARD_DEVIATION 11.25 |
| American Society of Anesthesiologists (ASA) Physical Status 2 | 3 Participants | 3 Participants | 6 Participants |
| American Society of Anesthesiologists (ASA) Physical Status 3 | 13 Participants | 16 Participants | 29 Participants |
| American Society of Anesthesiologists (ASA) Physical Status 4 | 1 Participants | 0 Participants | 1 Participants |
| Chronic liver disease (CLD) history | 0 Participants | 0 Participants | 0 Participants |
| Chronic obstructive pulmonary disease (COPD) History | 0 Participants | 0 Participants | 0 Participants |
| Diabetes History | 2 Participants | 1 Participants | 3 Participants |
| Primary Procedure Video-assisted thoracoscopic surgery (VATS) | 2 Participants | 2 Participants | 4 Participants |
| Primary Procedure Video-assisted thoracoscopic surgery (VATS) with Lobectomy | 12 Participants | 10 Participants | 22 Participants |
| Primary Procedure Video-assisted thoracoscopic surgery (VATS) with Wedge Biopsy | 3 Participants | 7 Participants | 10 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 17 participants | 19 participants | 36 participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 18 Participants |
| Tobacco History Current | 3 Participants | 2 Participants | 5 Participants |
| Tobacco History Never | 7 Participants | 5 Participants | 12 Participants |
| Tobacco History Quit more than 12 months ago | 7 Participants | 12 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 23 | 0 / 22 |
| other Total, other adverse events | 3 / 23 | 2 / 22 |
| serious Total, serious adverse events | 2 / 23 | 1 / 22 |
Outcome results
Primary
Numeric Rated Pain Scale 48-72 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 3 days post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale 48-72 Hours Post-operative | 3.333 score on a scale | Standard Deviation 2.179 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale 48-72 Hours Post-operative | 4.833 score on a scale | Standard Deviation 2.639 |
Primary
Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 0-4 hours post operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative | 4.824 score on a scale | Standard Deviation 2.531 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative | 5.176 score on a scale | Standard Deviation 2.744 |
Primary
Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 12-24 hours post operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative | 3.714 score on a scale | Standard Deviation 2.367 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative | 5.312 score on a scale | Standard Deviation 3.114 |
Primary
Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 2 days post operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative | 4.188 score on a scale | Standard Deviation 2.482 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative | 4.125 score on a scale | Standard Deviation 2.187 |
Primary
Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 4-8 hours post operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative | 3.867 score on a scale | Standard Deviation 2.774 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative | 3.133 score on a scale | Standard Deviation 2.386 |
Primary
Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 8-12 hours post operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative | 2.923 score on a scale | Standard Deviation 2.253 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative | 3.4 score on a scale | Standard Deviation 2.384 |
Primary
Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 0-4 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative | 6.765 score on a scale | Standard Deviation 2.306 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative | 7 score on a scale | Standard Deviation 2.784 |
Primary
Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 12-24 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative | 7.467 score on a scale | Standard Deviation 2.2 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative | 7.062 score on a scale | Standard Deviation 2.435 |
Primary
Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 24-48 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative | 6.875 score on a scale | Standard Deviation 2.391 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative | 7.5 score on a scale | Standard Deviation 2.309 |
Primary
Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 48-72 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative | 6.889 score on a scale | Standard Deviation 2.667 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative | 6.833 score on a scale | Standard Deviation 2.563 |
Primary
Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 4-8 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative | 7 score on a scale | Standard Deviation 2.171 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative | 5.357 score on a scale | Standard Deviation 2.872 |
Primary
Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning no pain and ten (10) meaning the worst pain imaginable
Time frame: 8-12 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative | 6.615 score on a scale | Standard Deviation 2.534 |
| Continuous Catheter Infusion Ropivacaine | Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative | 5.867 score on a scale | Standard Deviation 2.85 |
Secondary
Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Time frame: 0-4 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative | 679 milligrams | Standard Deviation 363 |
| Continuous Catheter Infusion Ropivacaine | Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative | 453 milligrams | Standard Deviation 459 |
Secondary
Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Time frame: 16-24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative | 835 milligrams | Standard Deviation 513 |
| Continuous Catheter Infusion Ropivacaine | Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative | 900 milligrams | Standard Deviation 596 |
Secondary
Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Time frame: 24-48 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative | 2159 milligrams | Standard Deviation 1393 |
| Continuous Catheter Infusion Ropivacaine | Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative | 2676 milligrams | Standard Deviation 1699 |
Secondary
Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Time frame: 48-72 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative | 1385 milligrams | Standard Deviation 1391 |
| Continuous Catheter Infusion Ropivacaine | Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative | 1453 milligrams | Standard Deviation 1843 |
Secondary
Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Time frame: 4-8 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative | 250 milligrams | Standard Deviation 358 |
| Continuous Catheter Infusion Ropivacaine | Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative | 329 milligrams | Standard Deviation 412 |
Secondary
Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Time frame: 8-16 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative | 988 milligrams | Standard Deviation 398 |
| Continuous Catheter Infusion Ropivacaine | Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative | 842 milligrams | Standard Deviation 462 |
Secondary
Gabapentin Consumption in Milligrams 0-4 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Time frame: 0-4 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Gabapentin Consumption in Milligrams 0-4 Hours Post-operative | 58.82 milligrams | Standard Deviation 100.37 |
| Continuous Catheter Infusion Ropivacaine | Gabapentin Consumption in Milligrams 0-4 Hours Post-operative | 68.42 milligrams | Standard Deviation 149.27 |
Secondary
Gabapentin Consumption in Milligrams 16-24 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Time frame: 16-24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Gabapentin Consumption in Milligrams 16-24 Hours Post-operative | 100.00 milligrams | Standard Deviation 122.47 |
| Continuous Catheter Infusion Ropivacaine | Gabapentin Consumption in Milligrams 16-24 Hours Post-operative | 189.47 milligrams | Standard Deviation 196.91 |
Secondary
Gabapentin Consumption in Milligrams 24-48 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Time frame: 24-48 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Gabapentin Consumption in Milligrams 24-48 Hours Post-operative | 223.53 milligrams | Standard Deviation 343.75 |
| Continuous Catheter Infusion Ropivacaine | Gabapentin Consumption in Milligrams 24-48 Hours Post-operative | 452.63 milligrams | Standard Deviation 505.93 |
Secondary
Gabapentin Consumption in Milligrams 48-72 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Time frame: 48-72 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Gabapentin Consumption in Milligrams 48-72 Hours Post-operative | 152.94 milligrams | Standard Deviation 260.09 |
| Continuous Catheter Infusion Ropivacaine | Gabapentin Consumption in Milligrams 48-72 Hours Post-operative | 300.00 milligrams | Standard Deviation 458.26 |
Secondary
Gabapentin Consumption in Milligrams 4-8 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Time frame: 4-8 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Gabapentin Consumption in Milligrams 4-8 Hours Post-operative | 52.94 milligrams | Standard Deviation 117.89 |
| Continuous Catheter Infusion Ropivacaine | Gabapentin Consumption in Milligrams 4-8 Hours Post-operative | 36.84 milligrams | Standard Deviation 76.09 |
Secondary
Gabapentin Consumption in Milligrams 8-16 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Time frame: 8-16 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Gabapentin Consumption in Milligrams 8-16 Hours Post-operative | 82.35 milligrams | Standard Deviation 113.11 |
| Continuous Catheter Infusion Ropivacaine | Gabapentin Consumption in Milligrams 8-16 Hours Post-operative | 115.79 milligrams | Standard Deviation 167.54 |
Secondary
Ketorolac Consumption in Milligrams 0-4 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Time frame: 0-4 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Ketorolac Consumption in Milligrams 0-4 Hours Post-operative | 1.765 milligrams | Standard Deviation 7.276 |
| Continuous Catheter Infusion Ropivacaine | Ketorolac Consumption in Milligrams 0-4 Hours Post-operative | 2.895 milligrams | Standard Deviation 7.695 |
Secondary
Ketorolac Consumption in Milligrams 16-24 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Time frame: 16-24 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Ketorolac Consumption in Milligrams 16-24 Hours Post-operative | 0 milligrams | Standard Deviation 0 |
| Continuous Catheter Infusion Ropivacaine | Ketorolac Consumption in Milligrams 16-24 Hours Post-operative | 8.421 milligrams | Standard Deviation 11.432 |
Secondary
Ketorolac Consumption in Milligrams 24-48 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Time frame: 24-48 hours post-operative.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Ketorolac Consumption in Milligrams 24-48 Hours Post-operative | 17.647 milligrams | Standard Deviation 35.669 |
| Continuous Catheter Infusion Ropivacaine | Ketorolac Consumption in Milligrams 24-48 Hours Post-operative | 21.842 milligrams | Standard Deviation 26.416 |
Secondary
Ketorolac Consumption in Milligrams 48-72 Hours Post-operative
Ketorolac is a pain medication that is not an opioid. The ketorolac use in milligrams will be compared in each group at different time points.
Time frame: 48-72 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Ketorolac Consumption in Milligrams 48-72 Hours Post-operative | 11.471 milligrams | Standard Deviation 24.607 |
| Continuous Catheter Infusion Ropivacaine | Ketorolac Consumption in Milligrams 48-72 Hours Post-operative | 5.526 milligrams | Standard Deviation 14.327 |
Secondary
Ketorolac Consumption in Milligrams 4-8 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Time frame: 4-8 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Ketorolac Consumption in Milligrams 4-8 Hours Post-operative | 3.529 milligrams | Standard Deviation 8.434 |
| Continuous Catheter Infusion Ropivacaine | Ketorolac Consumption in Milligrams 4-8 Hours Post-operative | 0.789 milligrams | Standard Deviation 3.441 |
Secondary
Ketorolac Consumption in Milligrams 8-16 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Time frame: 8-16 hours post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Ketorolac Consumption in Milligrams 8-16 Hours Post-operative | 6.176 milligrams | Standard Deviation 10.684 |
| Continuous Catheter Infusion Ropivacaine | Ketorolac Consumption in Milligrams 8-16 Hours Post-operative | 5.789 milligrams | Standard Deviation 10.576 |
Secondary
Length of Hospital Stay
Number of hours from admission to discharge
Time frame: From date of admission until date of discharge, an average of 72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Length of Hospital Stay | 72.00 Hours |
| Continuous Catheter Infusion Ropivacaine | Length of Hospital Stay | 58.00 Hours |
Secondary
Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Time frame: 0-4 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative | 23.47 milligram morphine equivalents (MME) | Standard Deviation 20.74 |
| Continuous Catheter Infusion Ropivacaine | Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative | 37.89 milligram morphine equivalents (MME) | Standard Deviation 22.73 |
Secondary
Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Time frame: 16-24 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative | 48.06 milligram morphine equivalents (MME) | Standard Deviation 44.36 |
| Continuous Catheter Infusion Ropivacaine | Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative | 64.64 milligram morphine equivalents (MME) | Standard Deviation 36.77 |
Secondary
Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Time frame: 24-48 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative | 67.71 milligram morphine equivalents (MME) | Standard Deviation 65.83 |
| Continuous Catheter Infusion Ropivacaine | Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative | 92.64 milligram morphine equivalents (MME) | Standard Deviation 57.43 |
Secondary
Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Time frame: 48-72 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative | 76.38 milligram morphine equivalents (MME) | Standard Deviation 80.33 |
| Continuous Catheter Infusion Ropivacaine | Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative | 105.61 milligram morphine equivalents (MME) | Standard Deviation 69.3 |
Secondary
Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Time frame: 4-8 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative | 29.00 milligram morphine equivalents (MME) | Standard Deviation 26.91 |
| Continuous Catheter Infusion Ropivacaine | Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative | 39.94 milligram morphine equivalents (MME) | Standard Deviation 23.83 |
Secondary
Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Time frame: 8-16 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative | 38.44 milligram morphine equivalents (MME) | Standard Deviation 34.04 |
| Continuous Catheter Infusion Ropivacaine | Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative | 52.53 milligram morphine equivalents (MME) | Standard Deviation 29.37 |
Secondary
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 0 to 4 hours post-operative). A negative number reflects reduced volume of air.
Time frame: 0-4 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative | -956.25 volume of air in cubic centimeters | Standard Deviation 528.796 |
| Continuous Catheter Infusion Ropivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative | -652.778 volume of air in cubic centimeters | Standard Deviation 596.429 |
Secondary
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 12 to 24 hours post-operative). A negative number reflects reduced volume of air.
Time frame: 12-24 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative | -718.333 volume of air in cubic centimeters | Standard Deviation 575.114 |
| Continuous Catheter Infusion Ropivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative | -853.333 volume of air in cubic centimeters | Standard Deviation 747.01 |
Secondary
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 24 to 48 hours post-operative). A negative number reflects reduced volume of air.
Time frame: 24-48 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative | -975 volume of air in cubic centimeters | Standard Deviation 640.538 |
| Continuous Catheter Infusion Ropivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative | -700 volume of air in cubic centimeters | Standard Deviation 537.936 |
Secondary
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 48 to 72 hours post-operative). A negative number reflects reduced volume of air.
Time frame: 48-72 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative | -906.25 volume of air in cubic centimeters | Standard Deviation 651.612 |
| Continuous Catheter Infusion Ropivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative | -642.857 volume of air in cubic centimeters | Standard Deviation 403.556 |
Secondary
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 4 to 8 hours post-operative). A negative number reflects reduced volume of air.
Time frame: 4-8 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative | -815.385 volume of air in cubic centimeters | Standard Deviation 632.582 |
| Continuous Catheter Infusion Ropivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative | -775 volume of air in cubic centimeters | Standard Deviation 765.544 |
Secondary
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 8 to 12 hours post-operative). A negative number reflects reduced volume of air.
Time frame: 8-12 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative | -1005.556 volume of air in cubic centimeters | Standard Deviation 682.113 |
| Continuous Catheter Infusion Ropivacaine | Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative | -959.091 volume of air in cubic centimeters | Standard Deviation 654.912 |
Secondary
Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Time frame: 12-24 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative | 8.24 score on a scale | Standard Deviation 0.96 |
| Continuous Catheter Infusion Ropivacaine | Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative | 7.29 score on a scale | Standard Deviation 1.36 |
Secondary
Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Time frame: 24-48 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative | 8.26 score on a scale | Standard Deviation 0.77 |
| Continuous Catheter Infusion Ropivacaine | Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative | 8.40 score on a scale | Standard Deviation 0.86 |
Secondary
Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Time frame: 48-72 hours post-operative
Population: The number of participants analyzed differs across outcome measures due to incomplete data collection for some outcomes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative | 8.56 score on a scale | Standard Deviation 0.9 |
| Continuous Catheter Infusion Ropivacaine | Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative | 8.52 score on a scale | Standard Deviation 0.95 |
Secondary
Total Intraoperative Opioid Consumption in Morphine Equivalent Dose
Total opioids administered in morphine equivalent dose (MED) in the operating room during the surgery. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Time frame: From start of surgery to end of surgery, an average of 2-3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Total Intraoperative Opioid Consumption in Morphine Equivalent Dose | 63.1 milligram morphine equivalents (MME) | Standard Deviation 31.7 |
| Continuous Catheter Infusion Ropivacaine | Total Intraoperative Opioid Consumption in Morphine Equivalent Dose | 64.1 milligram morphine equivalents (MME) | Standard Deviation 35.4 |