Exparel v Dexamethasone in RCR

Phase 4

• Conditions: Rotator Cuff Tears; Postoperative Pain
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hcl 0.5% Inj; Drug: Dexamethasone

• Registration Number: NCT06575010
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study Start: 2024-08-26
• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Last Update Submitted: 2024-08-26
• Study First Posted: 2024-08-28
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: Shoulder Block using Exparel + Dexamethasone	Dexamethasone	Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.
Group 2: Shoulder Block using Exparel + Dexamethasone	Bupivacaine Hcl 0.5% Inj	Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.
Group 1: Shoulder Block using Exparel	Bupivacaine Hcl 0.5% Inj	Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.
Group 2: Shoulder Block using Exparel + Dexamethasone	Liposomal bupivacaine	Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.
Group 1: Shoulder Block using Exparel	Liposomal bupivacaine	Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.

Primary Outcome Measures

Name	Time	Method
Postoperative narcotic medication use	14 days	Participants will be asked to record the amount of medication they take to control pain after surgery
Postoperative pain levels	14 days	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

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States