Clinical trial NCT02762071: Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty
Official title: Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Arthropathy
Shoulder Pain
Closed Fracture Proximal Humerus, Four Part
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2016-05-04
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale Pain Score at 24 Hours Postoperatively
timeFrame: At 24 hours after surgery
Secondary outcomes:
measure: Opioid Medication Consumption in Morphine Milligram Equivalents
timeFrame: Up to 4 days postoperatively
measure: Length of Hospital Stay
timeFrame: At the time of discharge from hospital, Up to 4 days
measure: Postoperative Visual Analog Scale (VAS) Pain Scores
timeFrame: Up to first postoperative visit, maximum 30 days
measure: Patient Satisfaction With Pain Management
timeFrame: At first postoperative visit, up to 30 days
measure: Length of Stay in the Post-anesthesia Care Unit (PACU)
timeFrame: At the time of discharge from PACU, Up to 1 day
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Johns Hopkins University
state: Maryland
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Johns Hopkins University
name: Uma Srikumaran, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: