Postoperative Pain Control in Total Shoulder Arthroplasty

NCT05068960 | Completed Phase 4 FDA Drug

• 1 other identifier: IRB-19-7479
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.

Conditions

Total Shoulder Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Narcotic usage

  Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents)

  Postoperatively (up to 1 week)

Secondary Outcomes (5)

• Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified)

  Postoperatively (at 1 week)

• Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively

  Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively

• American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively

  Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively

• Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale)

  Postoperatively (at 4 weeks)

• Non narcotic pain medication usage

  Postoperatively (up to 1 week)

Study Arms (2)

Study group

EXPERIMENTAL

The study group will receive an interscalene block consisting of 10 mL 0.5% bupivacaine and 10 mL of liposomal bupivacaine \[133mg\].

Drug: Liposomal bupivacaine; Drug: Bupivacaine

Control group

ACTIVE COMPARATOR

The control group will receive an interscalene block consisting of 20 mL of 0.5%bupivacaine alone.

Drug: Bupivacaine

Interventions

Liposomal bupivacaine DRUG

Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty

Also known as: Exparel

Study group

Bupivacaine DRUG

Interscalene block with bupivacaine for pain control following total shoulder arthroplasty

Also known as: Marcaine

Control group; Study group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty

You may not qualify if:

• Patients under the age of 50 years
• Patients over the age of 85
• Patients undergoing a revision shoulder procedure
• Documented drug or alcohol abuse
• Active narcotic use within 3 months prior to surgery
• Neurological deficit
• Allergy to amide anesthetics
• Oxycodone intolerance
• Unable to take Celebrex
• Enrollment in another clinical trial
• Comorbidity that is contraindicated with the administration of an interscalene block
• Cognitive or mental health status that interferes with study

Sponsors & Collaborators

• Scripps Clinic: lead

Study Sites (1)

Scripps Clinic

La Jolla, California, 92037, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Heinz Hoenecke, MD

  Scripps Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded. Surgeon, nurses, and other clinical care providers will be blinded. Research staff will be blinded. The only staff who knows study group assignment is the pharmacist and the anesthesiologist and preoperative nurse who will administer the interscalene block.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double Blinded Randomized Controlled Trial

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: October 6, 2021
• Study Start: March 1, 2021
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)