Phase 4 N=64 Randomized Treatment

Liposomal Bupivacaine in Rotator Cuff Repair

Rotator Cuff Injury

Bottom Line

View on ClinicalTrials.gov: NCT03738696 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Average Postoperative Pain Scores Over a 96 Hour Timeframe — 3.0; 3.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Exparel (Drug); Ropivacaine (Drug)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Average Postoperative Pain Scores Over a 96 Hour Timeframe	3.0; 3.5	—
SECONDARY Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe	56.4; 58.5	—
SECONDARY Average Analgesia Satisfaction Over a 96 Hour Timeframe	4.4; 4.4	—
SECONDARY Percentage of Participants With Analgesia Complications	13.1; 29.8	—
SECONDARY Average Sleep Quality Over a 96 Hour Timeframe	5.7; 5.2	—
SECONDARY Average Hours of Painless Sleep	4.9; 4.4	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03738696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.