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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05068960
Other study ID # IRB-19-7479
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date March 1, 2021
Est. completion date July 1, 2025

Study information

Verified date December 2023
Source Scripps Clinic
Contact Heinz Hoenecke, MD
Phone 858.554.7993
Email hoenecke.heinz@scrippshealth.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A double blind, prospective, randomized trial to evaluate postoperative pain, narcotic use, patient satisfaction, and function among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine.


Description:

In order to reduce narcotic abuse potential, orthopaedic surgeons have explored multimodal pain regimens in addition to regional anesthesia to improve postoperative pain control. One commonly used intervention to reduce postoperative shoulder pain has been the interscalene brachial plexus block. This block provides significant pain relief for shoulder procedures, but has been limited to less than 24 hours even with long acting anesthetics. In the setting of shoulder arthroplasty, this short-term pain control often leads to the need for increased narcotic pain medication. Since shoulder arthroplasty has been steadily increasing in the United States with an annual growth rate of 10.6%, it is imperative to control patients' postoperative pain without increasing their risk for opiate abuse. A potential method for achieving this is by using liposomal bupivacaine in the interscalene blocks. This study is a double blind, prospective, randomized trial to evaluate the postoperative pain profiles among shoulder arthroplasty patients receiving interscalene block with and without the addition of liposomal bupivacaine. The purpose of this study is to determine if patients undergoing shoulder arthroplasty with an interscalene brachial plexus block with liposomal bupivacaine (study group) or without liposomal bupivacaine (control group) will have differences in postoperative opiate consumption, patient-reported pain, satisfaction with surgery, and shoulder function.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 85 Years
Eligibility Inclusion Criteria: • Patients undergoing primary shoulder arthroplasty or reverse shoulder arthroplasty Exclusion Criteria: - Patients under the age of 50 years - Patients over the age of 85 - Patients undergoing a revision shoulder procedure - Documented drug or alcohol abuse - Active narcotic use within 3 months prior to surgery - Neurological deficit - Allergy to amide anesthetics - Oxycodone intolerance - Unable to take Celebrex - Enrollment in another clinical trial - Comorbidity that is contraindicated with the administration of an interscalene block - Cognitive or mental health status that interferes with study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Liposomal bupivacaine
Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty
Bupivacaine
Interscalene block with bupivacaine for pain control following total shoulder arthroplasty

Locations

Country Name City State
United States Scripps Clinic La Jolla California

Sponsors (1)

Lead Sponsor Collaborator
Scripps Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Narcotic usage Number and type of narcotic pain pills consumed during the first postoperative week (also converted into morphine equivalents) Postoperatively (up to 1 week)
Secondary Severity of pain and its impact on functioning (Brief Pain Inventory - Short Form modified) Patients' self-reported pain severity and impact on functioning as measured on the Brief Pain Inventory Short-Form modified survey Postoperatively (at 1 week)
Secondary Pain score (Numeric Rating Scale): Preoperatively, postoperatively, and change from preoperatively to postoperatively Patients' self-reported pain as measured on the Numeric Rating Scale Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Secondary American Shoulder and Elbow Surgeons (ASES) score: preoperatively, postoperatively, and change from preoperatively to postoperatively The ASES score is a 100-point scale that evaluates two dimensions of shoulder function: pain and performance in activities of daily living. Each of the two domains make up for 50 of the 100 points. A score of 0 indicates the worst shoulder condition and a score of 100 indicates the best shoulder condition. Preoperatively (up to 30 days before surgery) and postoperatively (at 4 weeks), and change from preoperatively to postoperatively
Secondary Satisfaction with the results of surgery (Self-Administered Patient Satisfaction Scale) Patients' satisfaction with results of surgery as measured on the Self-Administered Patient Satisfaction Scale Postoperatively (at 4 weeks)
Secondary Non narcotic pain medication usage Number and type of non-narcotic pain pills consumed during the first postoperative week Postoperatively (up to 1 week)
See also
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Recruiting NCT06143306 - Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement Phase 4
Completed NCT03887650 - LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs Phase 4
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