Shoulder Pain
Conditions
Brief summary
In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.
Interventions
10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
Sponsors
Study design
Eligibility
Inclusion criteria
* ASA I-III * Age 18 years or older * Scheduled for elective outpatient arthroscopic shoulder surgery
Exclusion criteria
* History of allergy to local anesthetic, or one of the study medications * Pre-existing neurological deficits * Psychiatric or cognitive disorders that prohibit patients from following study protocol * History of drug or alcohol abuse * Chronic opioid use (longer than 3 months) * Chronic pain syndromes * Infection at the site of injection * Patients with severe pulmonary disease * Herniated cervical disc, cervical myelopathy * Contraindication for general anesthesia and/or interscalene nerve block * Pregnancy * Open shoulder arthrotomies. * Non English speakers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours | First 72 hours pain | NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale (NRS) Pain With Movement | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome. |
| Opioid Consumption | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | Opioid consumption, measured in oral morphine equivalents |
| Patient Satisfaction With Pain Management: Scale | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction |
| Brief Pain Inventory Short-form | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life. |
| Numerical Rating Scale (NRS) Pain at Rest | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome. |
| Sensory Resolution | 24, 48, 72, 96 (if needed) hours postoperatively | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. |
| Motor Block Resolution | 24, 48, 72, 96 (if needed) hours postoperatively | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. |
| Time to Readiness for Discharge | Postanesthesia care unit (0-6 hours postoperative) | Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System. |
| Postanesthesia Care Unit Length of Stay | Postanesthesia care unit (0-6 hours postoperative) | Total length of PACU stay as defined by time of PACU admission to PACU discharge. |
| Duration of Analgesic Block | 24, 48, 72, 96 (if needed) hours postoperatively | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked When did your pain relief from the block completely wear off? This indicates the block duration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) | 55 |
| Standard Bupivacaine & Dexamethasone Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected | 56 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Standard Bupivacaine & Dexamethasone | Liposomal Bupivacaine & Standard Bupivacaine |
|---|---|---|---|
| Age, Continuous | 53 year | 49 year | 55 year |
| American Society of Anesthesiology Status ASA Status I | 22 Participants | 12 Participants | 10 Participants |
| American Society of Anesthesiology Status ASA status II | 89 Participants | 44 Participants | 45 Participants |
| Body Mass Index, kg/m^2 | 27.6 Kg/m^2 STANDARD_DEVIATION 4.1 | 27.5 Kg/m^2 STANDARD_DEVIATION 4.1 | 27.6 Kg/m^2 STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants | 52 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 5 Participants | 5 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 | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 91 Participants | 46 Participants | 45 Participants |
| Region of Enrollment United States | 111 Participants | 56 Participants | 55 Participants |
| Sex: Female, Male Female | 20 Participants | 8 Participants | 12 Participants |
| Sex: Female, Male Male | 91 Participants | 48 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 56 |
| other Total, other adverse events | 6 / 55 | 3 / 56 |
| serious Total, serious adverse events | 0 / 55 | 0 / 56 |
Outcome results
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.
Time frame: First 72 hours pain
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours | 2.4 score on a scale | Standard Deviation 1.9 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours | 3.4 score on a scale | Standard Deviation 1.9 |
Brief Pain Inventory Short-form
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Brief Pain Inventory Short-form | Postanesthesia care unit (0-6 hours postoperative) | 1.2 score on a scale | Standard Deviation 2 |
| Liposomal Bupivacaine & Standard Bupivacaine | Brief Pain Inventory Short-form | Postoperative day 1 | 1.4 score on a scale | Standard Deviation 2 |
| Liposomal Bupivacaine & Standard Bupivacaine | Brief Pain Inventory Short-form | Postoperative day 2 | 2.4 score on a scale | Standard Deviation 2.3 |
| Liposomal Bupivacaine & Standard Bupivacaine | Brief Pain Inventory Short-form | Postoperative day 3 | 2.2 score on a scale | Standard Deviation 2 |
| Liposomal Bupivacaine & Standard Bupivacaine | Brief Pain Inventory Short-form | Postoperative day 4 | 2.5 score on a scale | Standard Deviation 2.3 |
| Liposomal Bupivacaine & Standard Bupivacaine | Brief Pain Inventory Short-form | Postoperative day 7 | 2.2 score on a scale | Standard Deviation 2.1 |
| Standard Bupivacaine & Dexamethasone | Brief Pain Inventory Short-form | Postoperative day 4 | 3.6 score on a scale | Standard Deviation 2.1 |
| Standard Bupivacaine & Dexamethasone | Brief Pain Inventory Short-form | Postanesthesia care unit (0-6 hours postoperative) | 0.6 score on a scale | Standard Deviation 1.4 |
| Standard Bupivacaine & Dexamethasone | Brief Pain Inventory Short-form | Postoperative day 3 | 3.4 score on a scale | Standard Deviation 2.1 |
| Standard Bupivacaine & Dexamethasone | Brief Pain Inventory Short-form | Postoperative day 1 | 1.8 score on a scale | Standard Deviation 2.3 |
| Standard Bupivacaine & Dexamethasone | Brief Pain Inventory Short-form | Postoperative day 7 | 2.9 score on a scale | Standard Deviation 2.1 |
| Standard Bupivacaine & Dexamethasone | Brief Pain Inventory Short-form | Postoperative day 2 | 3.6 score on a scale | Standard Deviation 2.5 |
Duration of Analgesic Block
Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked When did your pain relief from the block completely wear off? This indicates the block duration.
Time frame: 24, 48, 72, 96 (if needed) hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Duration of Analgesic Block | 26 Hours |
| Standard Bupivacaine & Dexamethasone | Duration of Analgesic Block | 27 Hours |
Motor Block Resolution
Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Time frame: 24, 48, 72, 96 (if needed) hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Motor Block Resolution | 27 Hours |
| Standard Bupivacaine & Dexamethasone | Motor Block Resolution | 27 Hours |
Numerical Rating Scale (NRS) Pain at Rest
NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain at Rest | Postanesthesia care unit (0-6 hours postoperative) | 1.3 score on a scale | Standard Deviation 1.9 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 1 | 2.1 score on a scale | Standard Deviation 2.6 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 2 | 2.5 score on a scale | Standard Deviation 2.3 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 3 | 2.4 score on a scale | Standard Deviation 2.2 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 4 | 2.5 score on a scale | Standard Deviation 2 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 7 | 1.7 score on a scale | Standard Deviation 2 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 4 | 3.0 score on a scale | Standard Deviation 2.2 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain at Rest | Postanesthesia care unit (0-6 hours postoperative) | 0.9 score on a scale | Standard Deviation 1.8 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 3 | 3.3 score on a scale | Standard Deviation 2.4 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 1 | 3.0 score on a scale | Standard Deviation 2.5 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 7 | 2.3 score on a scale | Standard Deviation 2.2 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain at Rest | Postoperative day 2 | 4.1 score on a scale | Standard Deviation 2.7 |
Numerical Rating Scale (NRS) Pain With Movement
NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain With Movement | Postanesthesia care unit (0-6 hours postoperative) | 8.9 score on a scale | Standard Deviation 4.3 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 1 | 4.0 score on a scale | Standard Deviation 3.1 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 2 | 4.1 score on a scale | Standard Deviation 2.9 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 3 | 4.0 score on a scale | Standard Deviation 2.7 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 4 | 4.0 score on a scale | Standard Deviation 2.8 |
| Liposomal Bupivacaine & Standard Bupivacaine | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 7 | 3.9 score on a scale | Standard Deviation 2.6 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 4 | 4.9 score on a scale | Standard Deviation 2.4 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain With Movement | Postanesthesia care unit (0-6 hours postoperative) | 9.98 score on a scale | Standard Deviation 3.2 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 3 | 5.3 score on a scale | Standard Deviation 2.3 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 1 | 4.3 score on a scale | Standard Deviation 3.1 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 7 | 4.7 score on a scale | Standard Deviation 2.5 |
| Standard Bupivacaine & Dexamethasone | Numerical Rating Scale (NRS) Pain With Movement | Postoperative day 2 | 5.6 score on a scale | Standard Deviation 3.1 |
Opioid Consumption
Opioid consumption, measured in oral morphine equivalents
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Opioid Consumption | Postanesthesia care unit (0-6 hours postoperative) | 1.8 Oral Morphine Equivalents (mg) | Standard Deviation 4.5 |
| Liposomal Bupivacaine & Standard Bupivacaine | Opioid Consumption | Postoperative day 1 | 4.8 Oral Morphine Equivalents (mg) | Standard Deviation 8.6 |
| Liposomal Bupivacaine & Standard Bupivacaine | Opioid Consumption | Postoperative day 2 | 12.3 Oral Morphine Equivalents (mg) | Standard Deviation 15.6 |
| Liposomal Bupivacaine & Standard Bupivacaine | Opioid Consumption | Postoperative day 3 | 8.9 Oral Morphine Equivalents (mg) | Standard Deviation 12.5 |
| Liposomal Bupivacaine & Standard Bupivacaine | Opioid Consumption | Postoperative day 4 | 6.9 Oral Morphine Equivalents (mg) | Standard Deviation 13.8 |
| Liposomal Bupivacaine & Standard Bupivacaine | Opioid Consumption | Postoperative day 7 | 3.7 Oral Morphine Equivalents (mg) | Standard Deviation 7.4 |
| Standard Bupivacaine & Dexamethasone | Opioid Consumption | Postoperative day 4 | 9.7 Oral Morphine Equivalents (mg) | Standard Deviation 15.5 |
| Standard Bupivacaine & Dexamethasone | Opioid Consumption | Postanesthesia care unit (0-6 hours postoperative) | 1.7 Oral Morphine Equivalents (mg) | Standard Deviation 4.6 |
| Standard Bupivacaine & Dexamethasone | Opioid Consumption | Postoperative day 3 | 13.2 Oral Morphine Equivalents (mg) | Standard Deviation 14 |
| Standard Bupivacaine & Dexamethasone | Opioid Consumption | Postoperative day 1 | 8.1 Oral Morphine Equivalents (mg) | Standard Deviation 10.4 |
| Standard Bupivacaine & Dexamethasone | Opioid Consumption | Postoperative day 7 | 3.3 Oral Morphine Equivalents (mg) | Standard Deviation 7.2 |
| Standard Bupivacaine & Dexamethasone | Opioid Consumption | Postoperative day 2 | 18.2 Oral Morphine Equivalents (mg) | Standard Deviation 20.8 |
Patient Satisfaction With Pain Management: Scale
Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Patient Satisfaction With Pain Management: Scale | Postoperative day 1 | 9.3 score on a scale | Standard Deviation 1.4 |
| Liposomal Bupivacaine & Standard Bupivacaine | Patient Satisfaction With Pain Management: Scale | Postoperative day 3 | 9.2 score on a scale | Standard Deviation 1.4 |
| Liposomal Bupivacaine & Standard Bupivacaine | Patient Satisfaction With Pain Management: Scale | Postanesthesia care unit (0-6 hours postoperative) | 9.4 score on a scale | Standard Deviation 1.3 |
| Liposomal Bupivacaine & Standard Bupivacaine | Patient Satisfaction With Pain Management: Scale | Postoperative day 2 | 8.9 score on a scale | Standard Deviation 2.1 |
| Liposomal Bupivacaine & Standard Bupivacaine | Patient Satisfaction With Pain Management: Scale | Postoperative day 7 | 9.1 score on a scale | Standard Deviation 1.5 |
| Liposomal Bupivacaine & Standard Bupivacaine | Patient Satisfaction With Pain Management: Scale | Postoperative day 4 | 9.1 score on a scale | Standard Deviation 1.2 |
| Standard Bupivacaine & Dexamethasone | Patient Satisfaction With Pain Management: Scale | Postoperative day 7 | 8.4 score on a scale | Standard Deviation 2.1 |
| Standard Bupivacaine & Dexamethasone | Patient Satisfaction With Pain Management: Scale | Postanesthesia care unit (0-6 hours postoperative) | 9.8 score on a scale | Standard Deviation 0.5 |
| Standard Bupivacaine & Dexamethasone | Patient Satisfaction With Pain Management: Scale | Postoperative day 1 | 9.2 score on a scale | Standard Deviation 1.6 |
| Standard Bupivacaine & Dexamethasone | Patient Satisfaction With Pain Management: Scale | Postoperative day 2 | 8.6 score on a scale | Standard Deviation 1.8 |
| Standard Bupivacaine & Dexamethasone | Patient Satisfaction With Pain Management: Scale | Postoperative day 3 | 8.6 score on a scale | Standard Deviation 1.7 |
| Standard Bupivacaine & Dexamethasone | Patient Satisfaction With Pain Management: Scale | Postoperative day 4 | 8.5 score on a scale | Standard Deviation 1.7 |
Postanesthesia Care Unit Length of Stay
Total length of PACU stay as defined by time of PACU admission to PACU discharge.
Time frame: Postanesthesia care unit (0-6 hours postoperative)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Postanesthesia Care Unit Length of Stay | 163.5 minutes |
| Standard Bupivacaine & Dexamethasone | Postanesthesia Care Unit Length of Stay | 163 minutes |
Sensory Resolution
Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Time frame: 24, 48, 72, 96 (if needed) hours postoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Sensory Resolution | 27 Hours |
| Standard Bupivacaine & Dexamethasone | Sensory Resolution | 31 Hours |
Time to Readiness for Discharge
Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.
Time frame: Postanesthesia care unit (0-6 hours postoperative)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine & Standard Bupivacaine | Time to Readiness for Discharge | 90 minutes |
| Standard Bupivacaine & Dexamethasone | Time to Readiness for Discharge | 90 minutes |