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Exparel v Dexamethasone in RCR

NCT06575010 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-08-28

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2025-08-30
Completion
2025-08-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575010 on ClinicalTrials.gov