Liposomal Bupivacaine in Rotator Cuff Repair

University of Alabama at Birmingham64 enrolled

Overview

To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rotator Cuff Injury

Interventions

ExparelDRUG

A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

RopivacaineDRUG

A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing outpatient arthroscopic rotator cuff repair * Greater than or equal to 19 years of age at the time of surgery Exclusion Criteria: * Planned operative fixation of the biceps tendon or acromioclavicular joint * Opioid use 6 weeks before surgery * Gabapentin use 6 weeks before surgery * History of prior shoulder surgery on the operative limb * Severe pulmonary dysfunction * Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s) * History of radicular pain or neuropathy in the operative limb * Patients who are currently incapacitated for medical decision making

Locations (1)

UAB Hospital-Highlands

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Average Postoperative Pain Scores Over a 96 Hour Timeframe

Visual analog pain scores after operation \[0-10, with 10 being the worst pain\]

Time frame: Up to 96 hrs postoperative

Secondary Outcomes

Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe

oral morphine equivalents of all opioid-containing medications received

Time frame: Up to 96 hrs

Average Analgesia Satisfaction Over a 96 Hour Timeframe

Likert scale of analgesia satisfaction \[0-5, with 5 being the most satisfied\]

Time frame: Up to 96 hrs

Percentage of Participants With Analgesia Complications

Complications resulting from the method of analgesia utilized

Time frame: Up to 96 hrs

Average Sleep Quality Over a 96 Hour Timeframe

Scale of sleep quality \[0-10, with 10 being the most satisfied\]

Time frame: Up to 96 hrs postoperative

Average Hours of Painless Sleep

Hours of sleep uninterrupted by pain \[numerical, hours\]

Time frame: Up to 96 hrs postoperative

Data from ClinicalTrials.gov

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