Post-operative Pain, Total Shoulder Arthroplasty, Osteoarthritis of the Shoulder, Pain Management
Conditions
Keywords
Brachial Plexus, Liposomal Bupivacaine, Dexamethasone, Interscalene, Bupivacaine, Shoulder Arthroplasty, Regional anesthesia, Exparel
Brief summary
This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.
Interventions
DRUGLiposomal Bupivicaine 1.3%
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
DRUGBupivacaine 0.5%
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Sponsors
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
single-center, prospective, randomized controlled cross-sectional study
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient age \>18 years; * Lack of language barrier; * Informed consent obtained; * Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon; * American Society of Anesthesiology (ASA) physical status score I- III
Exclusion criteria
* Presence of a language barrier; * Inability to complete telephone and/or paper questionnaire; * Lack of consent; * Allergy to local anesthetic; * Chronic pain syndrome and/or preoperative opioid use \> 50 MME per day (including extended-release formulations and methadone); * Preoperative consultation to chronic pain service; * History of (\<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men); * Baseline peripheral neuropathy of the brachial plexus; * Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site; * Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy; * Weight \< 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V; * Revision arthroplasty; * Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block; * Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Consumption | Up to 120 postoperative hours | Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Opioid Medication | from the time of the block injection until discharge, assessed up to 72 postoperative hours. | From block time to the first dose of opioids given, measured in hours. |
| Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60 | Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain. |
| Hospital Length-of-stay | From the date of admission until discharge, assessed up to 72 hours. | From the date and time of admission to the date and time of discharge, Measured in hours. |
| Assessment of Patient Overall Satisfaction With Pain Control | POD4 - 60 days | Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate. |
| Duration of Sensory Nerve Block | Day 1, after Day 1 (day 2 to 60), and at postoperative day 60 | Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60. |
| Day of the Final Opioids Used | 0-96 postoperative hours | The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours. |
| Motor Recovery | PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60. | The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5): 0= No detectable muscle contraction (visible or palpation) 1. Detectable contraction (visible or palpation), but no movement achieved 2. Limb movement achieved, but unable to move against gravity 3. Limb movement against the resistance of gravity 4. Limb movement against gravity and external resistance 5. Normal strength The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data. |
| Incidence of Distress From Block Numbness | At PACU and Postoperative day 2 | On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Total Amount of Opioid Consumed During the Indicated Time Periods | 0-24, 24-48, 48-72, and 72-120 postoperative hours. | Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine 1.3% 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block | 45 |
| Bupivacaine 0.5% With Adjuncts 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 48-96 Hours Postoperative | Withdrawal by Subject | 0 | 2 |
| 60 Postoperative Days | Withdrawal by Subject | 1 | 0 |
| Preoperative-48 Hours Postoperative | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Bupivacaine 0.5% With Adjuncts | Total | Liposomal Bupivacaine 1.3% |
|---|---|---|---|
| Age, Continuous | 73 years | 73 years | 72 years |
| ASA Physical Status Classification | 2 units on a scale | 2 units on a scale | 2 units on a scale |
| Body Mass Index (BMI) | 31.60 kg/m^2 | 31.35 kg/m^2 | 31.30 kg/m^2 |
| Comorbidities COPD : no | 43 Participants | 88 Participants | 45 Participants |
| Comorbidities COPD : yes | 2 Participants | 2 Participants | 0 Participants |
| Comorbidities Diabetes Miletus : no | 36 Participants | 75 Participants | 39 Participants |
| Comorbidities Diabetes Miletus : yes | 9 Participants | 15 Participants | 6 Participants |
| Comorbidities Hyperlipidemia : no | 20 Participants | 39 Participants | 19 Participants |
| Comorbidities Hyperlipidemia : yes | 25 Participants | 51 Participants | 26 Participants |
| Comorbidities Hypertension : no | 20 Participants | 36 Participants | 16 Participants |
| Comorbidities Hypertension : yes | 25 Participants | 54 Participants | 29 Participants |
| Comorbidities Opioids at home : no | 39 Participants | 81 Participants | 42 Participants |
| Comorbidities Opioids at home : yes | 6 Participants | 9 Participants | 3 Participants |
| Comorbidities RA : no | 42 Participants | 87 Participants | 45 Participants |
| Comorbidities RA : yes | 3 Participants | 3 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 88 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Preoperative shoulder pain Mild | 20 Participants | 36 Participants | 16 Participants |
| Preoperative shoulder pain Moderate | 7 Participants | 22 Participants | 15 Participants |
| Preoperative shoulder pain None | 11 Participants | 23 Participants | 12 Participants |
| Preoperative shoulder pain Severe | 7 Participants | 9 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 42 Participants | 86 Participants | 44 Participants |
| Sex: Female, Male Female | 23 Participants | 45 Participants | 22 Participants |
| Sex: Female, Male Male | 22 Participants | 45 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 18 / 45 | 21 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Total Opioid Consumption
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
Time frame: Up to 120 postoperative hours
Population: 3 patients withdrew from Bupivacaine 0.5% with Adjuncts group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine 1.3% | Total Opioid Consumption | 71.25 MME |
| Bupivacaine 0.5% With Adjuncts | Total Opioid Consumption | 90.30 MME |
p-value: 0.127Wilcoxon (Mann-Whitney)
Secondary
Assessment of Patient Overall Satisfaction With Pain Control
Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate.
Time frame: POD4 - 60 days
Population: One patient withdrew consent from the Liposomal group just prior to 60 postoperative days, and three patients withdrew consent from the control group at the end of days 2, 3, and 4. The other missing data is from patients who lost to follow up from both groups.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liposomal Bupivacaine 1.3% | Assessment of Patient Overall Satisfaction With Pain Control | POD4 | 10/10 | 32 Participants |
| Liposomal Bupivacaine 1.3% | Assessment of Patient Overall Satisfaction With Pain Control | POD4 | below 10 | 9 Participants |
| Liposomal Bupivacaine 1.3% | Assessment of Patient Overall Satisfaction With Pain Control | POD4 | Missing data | 4 Participants |
| Liposomal Bupivacaine 1.3% | Assessment of Patient Overall Satisfaction With Pain Control | POD60 | 10/10 | 27 Participants |
| Liposomal Bupivacaine 1.3% | Assessment of Patient Overall Satisfaction With Pain Control | POD60 | below 10 | 12 Participants |
| Liposomal Bupivacaine 1.3% | Assessment of Patient Overall Satisfaction With Pain Control | POD60 | Missing data | 5 Participants |
| Bupivacaine 0.5% With Adjuncts | Assessment of Patient Overall Satisfaction With Pain Control | POD60 | below 10 | 13 Participants |
| Bupivacaine 0.5% With Adjuncts | Assessment of Patient Overall Satisfaction With Pain Control | POD4 | 10/10 | 24 Participants |
| Bupivacaine 0.5% With Adjuncts | Assessment of Patient Overall Satisfaction With Pain Control | POD60 | 10/10 | 28 Participants |
| Bupivacaine 0.5% With Adjuncts | Assessment of Patient Overall Satisfaction With Pain Control | POD4 | below 10 | 17 Participants |
| Bupivacaine 0.5% With Adjuncts | Assessment of Patient Overall Satisfaction With Pain Control | POD60 | Missing data | 1 Participants |
| Bupivacaine 0.5% With Adjuncts | Assessment of Patient Overall Satisfaction With Pain Control | POD4 | Missing data | 1 Participants |
p-value: 0.096Fisher Exact
p-value: 1Chi-squared
Secondary
Day of the Final Opioids Used
The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.
Time frame: 0-96 postoperative hours
Population: Three patients were missing from (Bupivacaine 0.5% with Adjuncts) group because of withdrawal.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine 1.3% | Day of the Final Opioids Used | 4 day |
| Bupivacaine 0.5% With Adjuncts | Day of the Final Opioids Used | 4 day |
p-value: 0.876Wilcoxon (Mann-Whitney)
Secondary
Duration of Sensory Nerve Block
Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60.
Time frame: Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | First sensation | Returned on day 2-60 | 9 Participants |
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | Full sensation | Not by day 60 | 0 Participants |
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | Full sensation | Returned on day 1 after the block | 11 Participants |
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | Full sensation | Missing data | 7 Participants |
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | First sensation | Not by day 60 | 0 Participants |
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | First sensation | Returned on day 1 after the block | 35 Participants |
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | First sensation | Missing data | 1 Participants |
| Liposomal Bupivacaine 1.3% | Duration of Sensory Nerve Block | Full sensation | Returned on day 2-60 | 27 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | First sensation | Missing data | 2 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | First sensation | Returned on day 2-60 | 10 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | First sensation | Returned on day 1 after the block | 33 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | Full sensation | Returned on day 1 after the block | 11 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | Full sensation | Returned on day 2-60 | 27 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | Full sensation | Not by day 60 | 2 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | First sensation | Not by day 60 | 0 Participants |
| Bupivacaine 0.5% With Adjuncts | Duration of Sensory Nerve Block | Full sensation | Missing data | 5 Participants |
p-value: 0.441Fishers Freeman Halton
p-value: 0.691Fishers Freeman Halton
Secondary
Hospital Length-of-stay
From the date and time of admission to the date and time of discharge, Measured in hours.
Time frame: From the date of admission until discharge, assessed up to 72 hours.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine 1.3% | Hospital Length-of-stay | 31.05 hour |
| Bupivacaine 0.5% With Adjuncts | Hospital Length-of-stay | 31.63 hour |
p-value: 0.112Wilcoxon (Mann-Whitney)
Secondary
Incidence of Distress From Block Numbness
On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day.
Time frame: At PACU and Postoperative day 2
Population: Although one patient from the control group decided to withdraw consent at the end of the second day following surgery, their data was included for this outcome as the withdrawal happened after collection. However, there was some missing data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Liposomal Bupivacaine 1.3% | Incidence of Distress From Block Numbness | PACU distress | No distress | 31 Participants |
| Liposomal Bupivacaine 1.3% | Incidence of Distress From Block Numbness | PACU distress | any distress | 14 Participants |
| Liposomal Bupivacaine 1.3% | Incidence of Distress From Block Numbness | PACU distress | Missing data | 0 Participants |
| Liposomal Bupivacaine 1.3% | Incidence of Distress From Block Numbness | POD2 Distress | No distress | 32 Participants |
| Liposomal Bupivacaine 1.3% | Incidence of Distress From Block Numbness | POD2 Distress | any distress | 12 Participants |
| Liposomal Bupivacaine 1.3% | Incidence of Distress From Block Numbness | POD2 Distress | Missing data | 1 Participants |
| Bupivacaine 0.5% With Adjuncts | Incidence of Distress From Block Numbness | POD2 Distress | any distress | 12 Participants |
| Bupivacaine 0.5% With Adjuncts | Incidence of Distress From Block Numbness | PACU distress | No distress | 31 Participants |
| Bupivacaine 0.5% With Adjuncts | Incidence of Distress From Block Numbness | POD2 Distress | No distress | 31 Participants |
| Bupivacaine 0.5% With Adjuncts | Incidence of Distress From Block Numbness | PACU distress | any distress | 14 Participants |
| Bupivacaine 0.5% With Adjuncts | Incidence of Distress From Block Numbness | POD2 Distress | Missing data | 2 Participants |
| Bupivacaine 0.5% With Adjuncts | Incidence of Distress From Block Numbness | PACU distress | Missing data | 0 Participants |
p-value: 1Chi-squared
p-value: 0.947Chi-squared
Secondary
Motor Recovery
The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5): 0= No detectable muscle contraction (visible or palpation) 1. Detectable contraction (visible or palpation), but no movement achieved 2. Limb movement achieved, but unable to move against gravity 3. Limb movement against the resistance of gravity 4. Limb movement against gravity and external resistance 5. Normal strength The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data.
Time frame: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liposomal Bupivacaine 1.3% | Motor Recovery | Any movement after day1 | 38 Participants |
| Liposomal Bupivacaine 1.3% | Motor Recovery | Return of full movement day 2-60 | 32 Participants |
| Liposomal Bupivacaine 1.3% | Motor Recovery | Any movement in day1 | 4 Participants |
| Liposomal Bupivacaine 1.3% | Motor Recovery | Not yet by day 60 | 3 Participants |
| Liposomal Bupivacaine 1.3% | Motor Recovery | Any movement missing data | 2 Participants |
| Liposomal Bupivacaine 1.3% | Motor Recovery | Return of full movement missing data | 10 Participants |
| Liposomal Bupivacaine 1.3% | Motor Recovery | Any movement in PACU | 1 Participants |
| Bupivacaine 0.5% With Adjuncts | Motor Recovery | Return of full movement missing data | 8 Participants |
| Bupivacaine 0.5% With Adjuncts | Motor Recovery | Any movement in PACU | 11 Participants |
| Bupivacaine 0.5% With Adjuncts | Motor Recovery | Any movement in day1 | 3 Participants |
| Bupivacaine 0.5% With Adjuncts | Motor Recovery | Any movement after day1 | 29 Participants |
| Bupivacaine 0.5% With Adjuncts | Motor Recovery | Any movement missing data | 2 Participants |
| Bupivacaine 0.5% With Adjuncts | Motor Recovery | Return of full movement day 2-60 | 31 Participants |
| Bupivacaine 0.5% With Adjuncts | Motor Recovery | Not yet by day 60 | 6 Participants |
p-value: 0.011Fisher' Freeman Halton
p-value: 0.536Fishers Freeman Halton
Secondary
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain.
Time frame: 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Population: Three patients withdrew consent from the control group (Bupivacaine 0.5% with adjuncts) and one from the liposomal bupivacaine group. The rest is missing data from lost to follow-up.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU | 0.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU-24 hours Minimum | 0.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU-24 hours Maximum | 2.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU-24 hours Average | 1.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 24-48 hours Minimum | 0.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 24-48 hours Maximum | 4.50 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 24-48 hours Average | 2.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 48-72 hours Minimum | 1.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 48-72 hours Maximum | 4.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 48-72 hours Average | 2.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 72-96 hours Minimum | 0.50 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 72-96 hours Maximum | 4.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 72-96 hours Average | 2.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 60 days postoperative Maximum | 5.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 60 days postoperative Average | 1.00 units on a scale 0-10 |
| Liposomal Bupivacaine 1.3% | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 60 days postoperative Minimum | 0.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 60 days postoperative Minimum | 0.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU | 0.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 48-72 hours Maximum | 6.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU-24 hours Minimum | 0.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 72-96 hours Average | 3.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU-24 hours Maximum | 1.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 48-72 hours Average | 3.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | PACU-24 hours Average | 0.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 60 days postoperative Average | 2.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 24-48 hours Minimum | 2.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 72-96 hours Minimum | 2.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 24-48 hours Maximum | 7.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 60 days postoperative Maximum | 6.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 24-48 hours Average | 4.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 72-96 hours Maximum | 5.00 units on a scale 0-10 |
| Bupivacaine 0.5% With Adjuncts | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | 48-72 hours Minimum | 2.00 units on a scale 0-10 |
p-value: 0.661Wilcoxon (Mann-Whitney)
p-value: 0.747Wilcoxon (Mann-Whitney)
p-value: 0.604Wilcoxon (Mann-Whitney)
p-value: 0.002Wilcoxon (Mann-Whitney)
p-value: <0.01Wilcoxon (Mann-Whitney)
p-value: <0.01Wilcoxon (Mann-Whitney)
p-value: 0.011Wilcoxon (Mann-Whitney)
p-value: 0.852Wilcoxon (Mann-Whitney)
p-value: 0.001Wilcoxon (Mann-Whitney)
p-value: 0.003Wilcoxon (Mann-Whitney)
p-value: 0.23Wilcoxon (Mann-Whitney)
p-value: 0.007Wilcoxon (Mann-Whitney)
p-value: 0.011Wilcoxon (Mann-Whitney)
p-value: 0.378Wilcoxon (Mann-Whitney)
p-value: 0.001Wilcoxon (Mann-Whitney)
p-value: 0.403Wilcoxon (Mann-Whitney)
Secondary
Time to First Opioid Medication
From block time to the first dose of opioids given, measured in hours.
Time frame: from the time of the block injection until discharge, assessed up to 72 postoperative hours.
Population: Missing data for 2 patients from the Liposomal Bupivacaine 1.3% group. 3 patients withdrew consents from the Bupivacaine 0.5% with Adjuncts group.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine 1.3% | Time to First Opioid Medication | 10.5667 hours |
| Bupivacaine 0.5% With Adjuncts | Time to First Opioid Medication | 12.025 hours |
p-value: 0.975Wilcoxon (Mann-Whitney)
Other Pre-specified
Total Amount of Opioid Consumed During the Indicated Time Periods
Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours.
Time frame: 0-24, 24-48, 48-72, and 72-120 postoperative hours.
Population: One patient withdrew consent on the second postoperative day from the control group, then two patients withdrew on the third and fourth postoperative days from the control group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Liposomal Bupivacaine 1.3% | Total Amount of Opioid Consumed During the Indicated Time Periods | 0-24 hours | 25.00 MME/day |
| Liposomal Bupivacaine 1.3% | Total Amount of Opioid Consumed During the Indicated Time Periods | 24-48 hours | 16.00 MME/day |
| Liposomal Bupivacaine 1.3% | Total Amount of Opioid Consumed During the Indicated Time Periods | 48-72 hours | 2.00 MME/day |
| Liposomal Bupivacaine 1.3% | Total Amount of Opioid Consumed During the Indicated Time Periods | 72-120 hours | 10.00 MME/day |
| Bupivacaine 0.5% With Adjuncts | Total Amount of Opioid Consumed During the Indicated Time Periods | 72-120 hours | 15.00 MME/day |
| Bupivacaine 0.5% With Adjuncts | Total Amount of Opioid Consumed During the Indicated Time Periods | 0-24 hours | 25.00 MME/day |
| Bupivacaine 0.5% With Adjuncts | Total Amount of Opioid Consumed During the Indicated Time Periods | 48-72 hours | 5.00 MME/day |
| Bupivacaine 0.5% With Adjuncts | Total Amount of Opioid Consumed During the Indicated Time Periods | 24-48 hours | 23.25 MME/day |
p-value: 0.648Wilcoxon (Mann-Whitney)
p-value: 0.285Wilcoxon (Mann-Whitney)
p-value: 0.122Wilcoxon (Mann-Whitney)
p-value: 0.367Wilcoxon (Mann-Whitney)