Quality of Recovery After Rotator Cuff Repair With Interscalene Liposomal Bupivacaine Versus Interscalene Nerve Catheter.
Jay W Schoenherr, Michael Gonzalez, Ricardo Serrano...
https://pubmed.ncbi.nlm.nih.gov/36458106/Actively Recruiting
Led by Melinda Seering · Updated on 2025-11-10
56
Participants Needed
1
Research Sites
13 weeks
Total Duration
Researchers are evaluating two methods for managing pain after total shoulder replacement surgery the use of an interscalene catheter and a single injection interscalene block with liposomal bupivacaine. This study aims to compare these approaches in terms of pain control, opioid use, cost, and patient outcomes, addressing the challenge of managing intense post-operative pain and improving recovery experience. Both methods are standard care options with distinct benefits and potential drawbacks, and this research seeks to identify which offers better results for patients. Participants will be randomly assigned to receive either an interscalene catheter placed pre-operatively by a skilled anesthesiologist, delivering continuous infusion of ropivacaine for 24 to 48 hours, or a single shot interscalene block using liposomal bupivacaine combined with bupivacaine. Both treatments are administered before surgery under anesthesia. The catheter method requires ongoing management of the infusion pump, while the single injection option offers prolonged pain relief through a slow-release anesthetic formulation. The study will assess these approaches during the initial hospital stay and follow patients up to three months after surgery. Throughout the study, participants will complete questionnaires evaluating pain, functionality, and quality of life before surgery and at multiple points up to six months post-operatively. Pain scores and opioid use will be tracked closely in the hospital and after discharge, with researchers also measuring costs and environmental impact related to each technique. The primary outcome is the functional pain score at one day after surgery, with additional assessments at 7, 30, and 90 days. This comprehensive monitoring aims to capture both short-term and longer-term effects of the treatments on recovery and patient satisfaction.
CONDITIONS
Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties
M
Melinda Seering, MD
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Melinda Seering
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Interscalene Catheter Infusion | Exparel Single Shot Interscalene Block |
|---|---|---|
| What it is | A continuous nerve block using a catheter placed near the brachial plexus before surgery, with an initial bolus of bupivacaine and a post-operative infusion of ropivacaine for ongoing pain relief. | A single-shot nerve block administered near the brachial plexus before surgery using a combination of liposomal bupivacaine (Exparel) and bupivacaine for extended pain relief after surgery. |
| Role in trial | Active comparator arm tested for ability to provide pain control after shoulder replacement surgery. | Active comparator arm using a single preoperative injection with sustained-release bupivacaine. |
| Primary use | Provides regional anesthesia and continuous postoperative pain relief for shoulder arthroplasty. | Intended to deliver extended postoperative pain relief with a single preoperative injection. |
| How it is given or performed | Placement of a catheter near the brachial plexus before surgery by a regional anesthesiologist, initial injection of 20 cc 0.5% bupivacaine, followed by a continuous infusion of 0.2% ropivacaine post-operatively at 8 cc/hr. | Single preoperative injection performed by a regional anesthesiologist with 133 mg liposomal bupivacaine and 10 cc 0.5% bupivacaine via interscalene approach. |
| Evidence status | Multiple studies report that continuous interscalene catheters provide effective perioperative pain control after shoulder replacement, but require pump management and more technical skill. | Clinical trials show single-shot Exparel interscalene blocks provide non-inferior pain control compared to continuous catheter techniques, with some studies reporting lower complication rates. |
| Important limitations | Catheter-based techniques may increase technical complexity, pump-related complications, and accidental dislodgement risk. Catheters often require patient, nursing, and anesthesiologist coordination. | Some studies show a potential for shorter duration of pain relief in select patients and rare adverse reactions to liposomal bupivacaine; unable to provide adjustable dosing after injection. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours post-operatively
Participants receive either a pre-operative interscalene catheter with continuous infusion or a single injection interscalene block with liposomal bupivacaine for pain control during shoulder replacement surgery.
1 pre-operative visit and hospital stay for surgery with 23 hours admission
Duration - 3 months
Participants complete pain and functional status assessments and report opioid use and complications at several time points following surgery.
Visits or surveys at 7 days, 14 days, 30 days, 2 weeks, 6 weeks, and 3 months post-operatively
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Lead Sponsor