Clinical trial NCT05068960: Postoperative Pain Control in Total Shoulder Arthroplasty
Official title: A Prospective Randomized Controlled Trial to Evaluate the Efficacy of an Interscalene Brachial Plexus Block and Multimodal Analgesia With and Without Liposomal Bupivacaine for Postoperative Pain Control in Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Shoulder Arthroplasty
Lead sponsor: Scripps Clinic
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blinded Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

Detailed description: In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks.

This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.

Eligibility criteria: Inclusion Criteria:

• Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty

Exclusion Criteria:

* Patients under the age of 50 years
* Patients over the age of 85
* Patients undergoing a revision shoulder procedure
* Documented drug or alcohol abuse
* Active narcotic use within 3 months prior to surgery
* Neurological deficit
* Allergy to amide anesthetics
* Oxycodone intolerance
* Unable to take Celebrex
* Enrollment in another clinical trial
* Comorbidity that is contraindicated with the administration of an interscalene block
* Cognitive or mental health status that interferes with study

Primary outcomes:
measure: Narcotic usage
timeFrame: Postoperatively (up to 1 week)
Secondary outcomes:
measure: Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)
timeFrame: Postoperatively (at 1 week)
measure: Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively
timeFrame: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
measure: American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively
timeFrame: Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
measure: Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)
timeFrame: Postoperatively (at 4 weeks)
measure: Non narcotic pain medication usage
timeFrame: Postoperatively (up to 1 week)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
Study officials:
affiliation: Scripps Health
name: Heinz Hoenecke, MD
role: PRINCIPAL_INVESTIGATOR
References: