Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

Not Applicable

Completed

Conditions: Arthropathy
Osteoarthritis
Shoulder Pain
Closed Fracture Proximal Humerus, Four Part

Interventions: Drug: Liposomal bupivacaine
Drug: Interscalene Nerve Block

Registration Number: NCT02762071

Lead Sponsor: Johns Hopkins University

Brief Summary: This study will compare interscalene nerve block versus liposomal bupivacaine (Exparel) for pain control after total shoulder replacements. Each method will be assessed in terms of post operative pain scores, pain medication consumption, length of stay, complications (nerve injuries, hematomas, cardiac/respiratory events) and rate of readmission due to pain. The aims of this study will be achieved through a randomized controlled trial and cost-effectiveness analysis.

Detailed Description: After the decision to proceed with shoulder replacement surgery, patients will be asked to participate in this randomized trial. Consent will be completed after explanation of each treatment group and the data to be collected. Patients will be randomized into one of the two treatment groups by simple randomization into one of two groups: Group 1 will receive interscalene nerve block and group 2 will receive liposomal bupivacaine for postoperative analgesia. Randomization will be stratified by site.

The surgeon at each site will be trained prior to enrollment on the correct way to perform Exparel injections intraoperatively. Patients in the interscalene nerve block group will be given a single shot block in the preoperative area by a fellowship-trained anesthesiologist.

The primary outcome is pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain). Secondary outcomes are postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 hours; VAS pain score at the first postoperative visit ; intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1); duration of stay in the post-anesthesia care unit (PACU); duration of hospital stay; and VAS score for satisfaction with pain control in the hospital and at home, assessed at participants' first postoperative visit. VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

Inclusion Criteria

Degenerative changes of the shoulder joint (documented by radiographs) in patients planning total joint replacement with one of the study's four fellowship-trained orthopaedic surgeons.
Patients who require revision surgeries, hemiarthroplasties, or who have chronic pain issues will be included.

Exclusion Criteria

Allergy to liposomal bupivacaine
Contraindications to the interscalene nerve block such as:
Preexisting neurologic defects
Local anesthetic allergy
Coagulopathy
Contralateral phrenic nerve dysfunction
Severe chronic obstructive pulmonary disease

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Liposomal bupivacaine	Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
Interscalene Nerve Block	Interscalene Nerve Block	Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Score at 24 Hours Postoperatively	At 24 hours after surgery	The primary outcome was pain score on a visual analog scale (VAS) at 24 hours postoperatively. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).

Secondary Outcome Measures

Name	Time	Method
Opioid Medication Consumption in Morphine Milligram Equivalents	Up to 4 days postoperatively	We analyzed intraoperative opioid consumption; postoperative opioid consumption at days 1, 2, 3, and 4; total opioid consumption at day 1 (intraoperative + postoperative day 1). This was measured in morphine milligram equivalents.
Length of Stay in the Post-anesthesia Care Unit (PACU)	At the time of discharge from PACU, Up to 1 day	Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.
Patient Satisfaction With Pain Management	At first postoperative visit, up to 30 days	Visual Analog Scale (VAS) score for satisfaction with pain control in the hospital and at home. This was assessed at subjects' first postoperative visit.VAS satisfaction scores range from 0 (not satisfied) to 10 (completely satisfied).
Length of Hospital Stay	At the time of discharge from hospital, Up to 4 days	Duration of stay in hospital (hours) after shoulder replacement surgery.
Postoperative Visual Analog Scale (VAS) Pain Scores	Up to first postoperative visit, maximum 30 days	We analyzed postoperative VAS pain scores at 6, 12, 18, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 hours and at the first postoperative visit. VAS pain scores range from 0 (no pain) to 10 (unbearable pain).

Trial Locations

Locations (2): University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Johns Hopkins University
🇺🇸
Columbia, Maryland, United States