Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06575010

Exparel v Dexamethasone in RCR

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Postoperative narcotic medication use

    Time frame: 14 days

    Participants will be asked to record the amount of medication they take to control pain after surgery

  2. Postoperative pain levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.