Exparel v Dexamethasone in RCR

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT06575010
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Postoperative Pain
  • Rotator Cuff Tears

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Liposomal bupivacaine — DRUG
    20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery
  • Bupivacaine Hcl 0.5% Inj — DRUG
    0.75% bupivacaine will be given in the shoulder block prior to surgery
  • Dexamethasone — DRUG
    10 mg Dexamethasone will be given in the shoulder block prior to surgery

Study Details

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.

Key Dates

Start date
Aug 26, 2024
Status verified
Aug 2024
Primary completion
Aug 30, 2025
Completion
Aug 30, 2025

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Postoperative narcotic medication use [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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