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NCT04047745 Clinical Trial

Post-operative Exparel Study Following Rotator Cuff Repair

Rotator Cuff Tears Clinical Trial

Official title:
The Use of Liposomal Bupivacaine Interscalene Brachial Plexus Block for Rotator Cuff Surgery: A Randomized, Double Blind, Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04047745
Other study ID # 2019Tucker
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2019
Est. completion date September 2021

Study information
Verified date August 2019
Source Rothman Institute Orthopaedics
Contact Director of Clinical Trials
Phone 267-339-7818
Email tiffany.morrison@rothmanortho.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary purpose of this study is to determine if the postoperative oral narcotics consumption in patients receiving liposomal bupivacaine (LB) interscalene brachial plexus nerve block (ISBPB) is different than the narcotics consumption receiving traditional bupivacaine ISBPB for arthroscopic rotator cuff repair analgesia.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 132
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Males and females aged 18 years or older with a full-thickness rotator cuff tear (confirmed on MRI) undergoing arthroscopic rotator cuff repair surgery.

- Anesthesiologists physical status 1, 2, or 3 and normal preoperative motor (Lovett scale: biceps, wrist, thumb) and sensory function.

Exclusion Criteria:

- Revision shoulder surgery

- History of more than 1 prior surgery performed on the operative shoulder

- Concomitant severe glenohumeral arthritis

- Concomitant adhesive capsulitis

- Worker's compensation claim

- Pregnancy

- History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics

- History of renal or hepatic failure

- Chronic neuromuscular deficit affecting the surgical limb.

- Uncontrolled psychiatric or neurologic disorder

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Liposomal bupivacaine
interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
• Ropivacaine injection
interscale nerve block administered before surgery using 30mL 0.5% ropivacaine

Locations
Country Name City State
United States Rothman Orthopaedics at Egg Harbor Township Egg Harbor Township New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary opioid consumption postsurgical opioid consumption surgery through 48 hours post-op
See also
  Status Clinical Trial Phase
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Completed NCT04552925 - Exercises With Electromyographic Biofeedback in Conservative Treatment of Massive Rotator Cuff Tears N/A
Completed NCT01029574 - Platelet Rich Plasma on Rotator Cuff Repair Phase 3
Not yet recruiting NCT05817578 - Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm
Not yet recruiting NCT05670080 - Does MI Have a Therapeutic Role in Arthroscopic Rotator Cuff Repair? N/A
Suspended NCT04421417 - The Effect of Microfracture Procedure on Rotator Cuff Tendon Healing N/A
Recruiting NCT06156423 - Investigation of the Effect of Motor Control Exercises in Patients Undergoing Rotator Cuff Surgery N/A
Completed NCT06145815 - Machine Learning Predictive Model for Rotator Cuff Repair Failure
Not yet recruiting NCT05009498 - Vitamin D3 Supplementation for Vitamin D Deficiency in Rotator Cuff Repair Surgery N/A
Terminated NCT04855968 - The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption N/A
Completed NCT04594408 - Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery Phase 4
Not yet recruiting NCT04538001 - Safety and Efficacy of Rotator Cuff Function Restoration Balloon in Irreparable Rotator Cuff Tear N/A
Completed NCT04710966 - Comparison Between Arthroscopic Debridement and Repair for Partial-thickness Rotator Cuff Tears N/A
Recruiting NCT06192459 - Effect of the Muscle Strength and Range of Motion Training for Post-platelet Rich Plasma Injection in People With Rotator Cuff Partial Tear N/A
Recruiting NCT05925881 - Lower Trapezius Transfer vs Bridging Reconstruction N/A
Recruiting NCT05988541 - Rotator Cuff Integrity and Clinical Outcomes 5 Years After Repair. N/A
Not yet recruiting NCT04587037 - A Clinical Study Comparing Superior Capsule Reconstruction Using Different Graft for Irreparable Rotator Cuff Tear N/A
Not yet recruiting NCT04584476 - Superior Capsular Reconstruction Versus. Partial Repair for Irreparable Rotator Cuff Tears N/A
Active, not recruiting NCT01586351 - Rotator Cuff Reconstruction With Xenologous Dermis-patch Augmentation and ACP® - Injection N/A