Exparel v Dexamethasone in RCR

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-26

Study Completion Date

2025-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rotator Cuff Tears Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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

Bupivacaine Hcl 0.5% Inj

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Liposomal bupivacaine

Intervention Type DRUG

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

Bupivacaine Hcl 0.5% Inj

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

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

Interventions

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Liposomal bupivacaine

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

Intervention Type DRUG

Bupivacaine Hcl 0.5% Inj

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

Intervention Type DRUG

Dexamethasone

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes