Exparel v Dexamethasone in RCR

NCT06575010 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 2024-0726SNAM
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1: Shoulder Block using Exparel

ACTIVE COMPARATOR

Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery.

Drug: Liposomal bupivacaine; Drug: Bupivacaine Hcl 0.5% Inj

Group 2: Shoulder Block using Exparel + Dexamethasone

ACTIVE COMPARATOR

Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery.

Drug: Liposomal bupivacaine; Drug: Bupivacaine Hcl 0.5% Inj; Drug: Dexamethasone

Interventions

Liposomal bupivacaine DRUG

20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery

Group 1: Shoulder Block using Exparel; Group 2: Shoulder Block using Exparel + Dexamethasone

Bupivacaine Hcl 0.5% Inj DRUG

0.75% bupivacaine will be given in the shoulder block prior to surgery

Group 1: Shoulder Block using Exparel; Group 2: Shoulder Block using Exparel + Dexamethasone

Dexamethasone DRUG

10 mg Dexamethasone will be given in the shoulder block prior to surgery

Group 2: Shoulder Block using Exparel + Dexamethasone

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: August 26, 2024
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

US (1)