Liposomal Bupivacaine for Pain Control After Total Shoulder Arthroplasty

NCT02762071 | Completed Results

• 1 other identifier: IRB00063657
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis; Arthropathy; Shoulder Pain; Closed Fracture Proximal Humerus, Four Part

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Opioid Medication Consumption in Morphine Milligram Equivalents

  Up to 4 days postoperatively

• Length of Hospital Stay

  At the time of discharge from hospital, Up to 4 days

• Postoperative Visual Analog Scale (VAS) Pain Scores

  Up to first postoperative visit, maximum 30 days

• Patient Satisfaction With Pain Management

  At first postoperative visit, up to 30 days

• Length of Stay in the Post-anesthesia Care Unit (PACU)

  At the time of discharge from PACU, Up to 1 day

Study Arms (2)

Interscalene Nerve Block

ACTIVE COMPARATOR

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

Liposomal Bupivacaine

EXPERIMENTAL

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

Interventions

Liposomal bupivacaine DRUG

Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.

Also known as: Exparel

Liposomal Bupivacaine

Interscalene Nerve Block DRUG

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.

Interscalene Nerve Block

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (2)

Johns Hopkins University

Columbia, Maryland, 21044, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases; Shoulder Pain

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Uma Srikumaran
• Organization: Johns Hopkins University

us@jhmi.edu

443-546-1550

Study Officials

• Uma Srikumaran, MD, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 4, 2016
• Study Start: April 1, 2016
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: March 30, 2020
• Results First Posted: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)