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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03738696
Other study ID # IRB-300002544
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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