Exparel v Dexamethasone in RCR

Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial

Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Pain; Rotator Cuff Tears
• Intervention / Treatment: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hcl 0.5% Inj; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants having a primary rotator cuff repair
• Age 18 and older
• English speaking
• Ability to complete surveys by phone or in person
• Ability to provide informed consent

Exclusion Criteria:

• Revision rotator cuff repair (RCR) cases
• Participants having an open RCR
• Allergies and/or medical contra-indications to study medications
• Non-English speakers
• Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
• Rotator cuff repair needing Graft Augmentation
• Known alcohol or narcotic abuse history
• Existing contract with a pain specialist due to underlying preoperative pain syndrome
• Preoperative opioid use within the 3 months prior to surgery

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Shoulder Block using Exparel; Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.	Drug: Liposomal bupivacaine; 20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery; Drug: Bupivacaine Hcl 0.5% Inj; 0.75% bupivacaine will be given in the shoulder block prior to surgery
Active Comparator: Group 2: Shoulder Block using Exparel + Dexamethasone; Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.	Drug: Liposomal bupivacaine; 20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery; Drug: Bupivacaine Hcl 0.5% Inj; 0.75% bupivacaine will be given in the shoulder block prior to surgery; Drug: Dexamethasone; 10 mg Dexamethasone will be given in the shoulder block prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative narcotic medication use	Participants will be asked to record the amount of medication they take to control pain after surgery	14 days
Postoperative pain levels	This will be measured by providing participants the visual analog scale (VAS) questionnaire as well as a postoperative pain recording diary to complete after surgery	14 days

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Estimated): August 26, 2024
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): August 30, 2025

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: 2024-0726SNAM

Drug and device information, study documents

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