Liposomal Bupivacaine in Rotator Cuff Repair

Rotator Cuff Injury Clinical Trial

Official title:

Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738696
• Other study ID #: IRB-300002544
• Status: Completed
• Phase: Phase 4
• Start date: December 15, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: May 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Injury

Intervention

Drug:
• Exparel
A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
• Ropivacaine
A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain

Locations

Country	Name	City	State
United States	UAB Hospital-Highlands	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Postoperative Pain Scores Over a 96 Hour Timeframe	Visual analog pain scores after operation [0-10, with 10 being the worst pain]	Up to 96 hrs postoperative
Secondary	Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe	oral morphine equivalents of all opioid-containing medications received	Up to 96 hrs
Secondary	Average Analgesia Satisfaction Over a 96 Hour Timeframe	Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]	Up to 96 hrs
Secondary	Percentage of Participants With Analgesia Complications	Complications resulting from the method of analgesia utilized	Up to 96 hrs
Secondary	Average Sleep Quality Over a 96 Hour Timeframe	Scale of sleep quality [0-10, with 10 being the most satisfied]	Up to 96 hrs postoperative
Secondary	Average Hours of Painless Sleep	Hours of sleep uninterrupted by pain [numerical, hours]	Up to 96 hrs postoperative