Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762071
• Other study ID #: IRB00063657
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: April 15, 2019

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy
• Closed Fracture Proximal Humerus, Four Part
• Fractures, Closed
• Joint Diseases
• Osteoarthritis
• Shoulder Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Columbia	Maryland
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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