Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

Liposomal Bupivacaine vs. Interscalene Nerve Block for Pain Control After Total Shoulder Arthroplasty: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Shoulder Pain; Arthropathy; Closed Fracture Proximal Humerus, Four Part
• Intervention / Treatment: Drug: Interscalene Nerve Block; Drug: Liposomal bupivacaine

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).

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Johns Hopkins University
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: 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.
Experimental: Liposomal Bupivacaine; Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.	Drug: Liposomal bupivacaine; Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale Pain Score at 24 Hours Postoperatively	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).	At 24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Medication Consumption in Morphine Milligram Equivalents	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.	Up to 4 days postoperatively
Length of Hospital Stay	Duration of stay in hospital (hours) after shoulder replacement surgery.	At the time of discharge from hospital, Up to 4 days
Postoperative Visual Analog Scale (VAS) Pain Scores	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).	Up to first postoperative visit, maximum 30 days
Patient Satisfaction With Pain Management	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).	At first postoperative visit, up to 30 days
Length of Stay in the Post-anesthesia Care Unit (PACU)	Duration of stay in the post-anesthesia care unit (minutes) after shoulder replacement surgery.	At the time of discharge from PACU, Up to 1 day

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Fractures, Bone; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Fractures, Closed; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00063657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No