Pain, Postoperative
Conditions
Brief summary
Arthroscopic rotator cuff repair often causes significant postoperative pain. An interscalene nerve catheter is an effective and proven method to help reduce postoperative pain and decrease opioid use around the time of shoulder surgery. Liposomal bupivacaine (Exparel) was recently approved by the FDA for use around the interscalene brachial plexus, and it has been shown to be an effective option, but its analgesic efficacy has limited data. Both techniques are currently being used at the UNC's Ambulatory Surgery Center (ASC) for analgesia after shoulder arthroscopy. The goal is to ensure that the fairly new Exparel option provides non-inferior analgesia as compared to the prior standard practice of placing a nerve catheter with plain bupivacaine. The investigators hope to ensure the quality of pain control around the time of shoulder arthroscopy at this institution by prospectively and rigorously collecting data during regular follow up.
Detailed description
This is a prospective comparison of patients undergoing rotator cuff repair that receive one of two types of interscalene nerve block, both of which are currently being used at UNC. Group 1 will be comprised of patients with a preoperative interscalene nerve catheter placed with 20 mL 0.25% bupivacaine and a 0.2% ropivacaine infusion by an OnQ pain pump. Group 2 will be comprised of patients with a preoperative interscalene nerve block placed with 10 mL 0.5% bupivacaine and 10 mL 1.3% Liposomal Bupivacaine (Exparel). All patients in both groups will have a similar intraoperative general anesthetic with multimodal analgesic pre-op oral medications.
Interventions
PROCEDURESingle injection peripheral nerve block with liposomal bupivacaine (Exparel)
10 mL/133 mg liposomal bupivacaine and 10 mL 0.5% bupivacaine
PROCEDURESingle injection peripheral nerve block with 0.25% bupivacaine and subsequent peripheral nerve catheter with 0.2% bupivacaine infusion via onQ pain pump
20 mL 0.25% bupivacaine block and subsequent 10 mL/hr 0.2% bupivacaine infusion for 48 hours
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients age \> 18 undergoing arthroscopic rotator cuff repair at the ambulatory surgery center at the University of North Carolina
Exclusion criteria
the below are simply contraindications to regional anesthesia in general, this is a pragmatic study to evaluate the quality of care for these patients with no additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery 15 Score (QOR15) | 48 hours postoperatively | The QoR15 provides a valid, extensive, and efficient evaluation of postoperative quality of recovery. The QOR15 has 15 questions on a 0-10 point scale, so the QOR15 score can range from 0-150, the higher the score, the better the quality of recovery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Opioid Dose in Morphine Equivalents | postoperative days 1, 2 & 3 | total opioid administered over the first 3 postoperative days |
| Percentage of Patients with a Highest Pain Score > 3 | postoperative days 1, 2 & 3 | Visual analog pain scores after operation \[0-10, with 10 being the worst pain\] |
Countries
United States
Outcome results
None listed