RecruitingPhase 4NCT05868330

Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties

A Feasibility Randomized Control Comparison of Peripheral Interscalene Catheter to Liposomal Bupivacaine Single Injection for Interscalene Blocks Used in Pain Control for Total Shoulder Arthroplasties


Sponsor

Melinda Seering

Enrollment

56 participants

Start Date

Aug 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Comparison of post-operative pain after total shoulder surgery. The Principle Investigator will be comparing Exparel single shot block to Interscalene catheter


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study compares two nerve block approaches for pain control after reverse shoulder replacement surgery: a single-injection interscalene nerve block (one-time numbing injection near the neck) versus a continuous interscalene nerve block catheter (a small tube left in place that delivers ongoing pain medication for days). Shoulder replacement is a major surgery with significant post-operative pain, and effective nerve blocks can reduce the need for opioid medications. The question is whether the sustained relief from a catheter justifies its additional complexity compared to a simpler one-time injection. Eligible participants are adults aged 18–89 undergoing elective reverse shoulder replacement, classified as ASA I–III (meaning reasonably healthy), who give informed consent and are suitable for regional anesthesia. People with contraindications to nerve blocks (such as those on blood thinners), severe lung disease, allergy to the local anesthetics used, nerve damage in the arm being operated on, kidney or liver failure, pregnancy, inability to communicate in English, chronic high opioid use, or those undergoing fracture repair or revision surgery are excluded. Participants will be randomized to one of the two block types and followed for pain scores, opioid use, and any complications. This research is important because shoulder arthroplasty is one of the fastest-growing orthopedic procedures in the U.S., and optimizing post-operative pain management directly affects recovery speed, opioid exposure, and patient satisfaction.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREInterscalene Catheter

Pre-operatively the patient will have a interscalene catheter placed by a regional skilled anesthesiologist. The initial block will be with 20 cc of 0.5% Bupivacaine and maintained on an infusion post-operatively at 8cc/hr of 0.2% ropivacaine as is our intuitions protocol

PROCEDUREExparel Single Shot Interscalene Block

Pre-operatively the patient will have a interscalene single shot block with 133 mg Liposomal Bupivacaine and 10 ccs 0.5% Bupivacaine placed by a regional skilled anesthesiologist.


Locations(1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

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NCT05868330


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