Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair
| Registry | NCT03738696 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 64 (Actual) |
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| Sponsor | University of Alabama at Birmingham (Other); collaborators: Pacira Pharmaceuticals, Inc |
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| Conditions | Rotator Cuff Injury |
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| Interventions | Exparel, Ropivacaine (Drug) |
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| Dates | start 2019-12-15, primary completion 2022-01-01, completion 2022-01-01, first posted 2018-11-13, last updated 2024-05-16 |
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| Locations | 1 site in United States |
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-Summary
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Liposomal bupivacaine Interscalene Block | Experimental | Drug: Exparel | Interscalene block:
* 10cc (133mg) liposomal bupivacaine;PLUS
* 10cc 0.25% bupivacaine |
| Ropivacaine Interscalene Catheter | Active comparator | Drug: Ropivacaine | * 20cc 0.25% bupivacaine interscalene block; PLUS
* Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs) |
- Exparel (Drug), also known as liposomal bupivacaine: A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
- Ropivacaine (Drug): A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
+Outcome measures
Primary outcomes
- Average Postoperative Pain Scores Over a 96 Hour Timeframe [Up to 96 hrs postoperative]: Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]
Secondary outcomes
- Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe [Up to 96 hrs]: oral morphine equivalents of all opioid-containing medications received
- Average Analgesia Satisfaction Over a 96 Hour Timeframe [Up to 96 hrs]: Likert scale of analgesia satisfaction \[0-5, with 5 being the most satisfied\]
- Percentage of Participants With Analgesia Complications [Up to 96 hrs]: Complications resulting from the method of analgesia utilized
- Average Sleep Quality Over a 96 Hour Timeframe [Up to 96 hrs postoperative]: Scale of sleep quality \[0-10, with 10 being the most satisfied\]
- Average Hours of Painless Sleep [Up to 96 hrs postoperative]: Hours of sleep uninterrupted by pain \[numerical, hours\]
+Eligibility
Sex: All, ages: 19 Years to any
Inclusion Criteria:
* Undergoing outpatient arthroscopic rotator cuff repair
* Greater than or equal to 19 years of age at the time of surgery
Exclusion Criteria:
* Planned operative fixation of the biceps tendon or acromioclavicular joint
* Opioid use 6 weeks before surgery
* Gabapentin use 6 weeks before surgery
* History of prior shoulder surgery on the operative limb
* Severe pulmonary dysfunction
* Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
* History of radicular pain or neuropathy in the operative limb
* Patients who are currently incapacitated for medical decision making
+Posted results
Participant flow
| Milestone | Liposomal Bupivacaine Block | Ropivacaine Interscalene Catheter |
|---|
| Started | 28 | 36 |
| Completed | 20 | 21 |
| Not completed | 8 | 15 |
Outcome results
- Average Postoperative Pain Scores Over a 96 Hour Timeframe (Primary), Mean, score on a scale: Liposomal Bupivacaine Block 3.0 +/- 2.7; Ropivacaine Interscalene Catheter 3.5 +/- 3.0
- Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe (Secondary), Mean, morphine milligram equivalents: Liposomal Bupivacaine Block 56.4 +/- 42.9; Ropivacaine Interscalene Catheter 58.5 +/- 40.8
- Average Analgesia Satisfaction Over a 96 Hour Timeframe (Secondary), Mean, score on a scale: Liposomal Bupivacaine Block 4.4 +/- 0.9; Ropivacaine Interscalene Catheter 4.4 +/- 0.8
- Percentage of Participants With Analgesia Complications (Secondary), Number, percentage of participants: Liposomal Bupivacaine Block 13.1; Ropivacaine Interscalene Catheter 29.8
- Average Sleep Quality Over a 96 Hour Timeframe (Secondary), Mean, score on a scale: Liposomal Bupivacaine Block 5.7 +/- 2.5; Ropivacaine Interscalene Catheter 5.2 +/- 2.6
- Average Hours of Painless Sleep (Secondary), Mean, hours of uninterrupted sleep (longest): Liposomal Bupivacaine Block 4.9 +/- 2.5; Ropivacaine Interscalene Catheter 4.4 +/- 2.4
Adverse events
Time frame: 12 weeks
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Liposomal Bupivacaine Block | 0/28 (0.0%) | 0/28 (0.0%) | 8/28 (28.6%) |
| Ropivacaine Interscalene Catheter | 0/33 (0.0%) | 0/33 (0.0%) | 12/33 (36.4%) |
Other adverse events by term
| Term | Organ system | Liposomal Bupivacaine Block | Ropivacaine Interscalene Catheter |
|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 8/28 | 12/33 |
+Locations (1)
| Facility | City | Country | Status |
|---|
| UAB Hospital-Highlands | Birmingham, Alabama | United States | |
+Study documents