Exparel v Dexamethasone in RCR

Rothman Institute Orthopaedics126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

126

Conditions

Rotator Cuff Tears Postoperative Pain

Interventions

Liposomal bupivacaineDRUG

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

Bupivacaine Hcl 0.5% InjDRUG

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

DexamethasoneDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Postoperative narcotic medication use

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

Time frame: 14 days

Postoperative pain levels

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

Time frame: 14 days

Data from ClinicalTrials.gov

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