Exparel v Dexamethasone in RCR

Rothman Institute Orthopaedics

Status and phase: Invitation-only; Phase 4

Conditions: Postoperative Pain; Rotator Cuff Tears

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06575010

2024-0726SNAM

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

126 participants in 2 patient groups

Group 1: Shoulder Block using Exparel

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hcl 0.5% Inj

Drug: Liposomal bupivacaine

Group 2: Shoulder Block using Exparel + Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Bupivacaine Hcl 0.5% Inj

Drug: Dexamethasone

Drug: Liposomal bupivacaine