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Interscalene Bupivacaine With Either Liposomal Bupivacaine or Continuous Peripheral Nerve Block for Shoulder Arthroscopy

NCT03816982 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-08-23

No results posted yet for this study

Summary

This investigation will be a prospective, randomized trial. The study population will consist of adult patients scheduled to undergo major shoulder arthroscopy procedures with anesthesiology at the Ambulatory Services Center (Outpatient Surgery Center). Forty-six subjects will be enrolled in this study and will be randomized into one of two arms: 1) Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB, 2) Single-injection bupivacaine HCl plus liposomal bupivacaine included in the same injection. These procedures will take place, using an ultrasound-guided method, approximately one hour prior to surgical procedure. Subjects will be followed for seven days to assess pain control by the Modified Brief Pain Inventory (MBPI) survey and outcome factors related to study and procedure using the American Shoulder and Elbow Surgeon Shoulder Score (ASES Shoulder Score).

Conditions

  • Shoulder Pain

Interventions

PROCEDURE

Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB

Patients in the bupivacaine CISB group will undergo catheter placement with ultrasound guidance only by faculty who are part of the regional anesthesia division. A 20 mL single bolus ISB with 0.25% bupivacaine will be administered followed by catheter infusion of 0.125% bupivacaine at a rate of 5mL/hour postoperatively by the ON-Q pump

PROCEDURE

Single-injection bupivacaine HCl plus liposomal bupivacaine

Patients in the liposomal bupivacaine with added bupivacaine HCl ISB group will be given a single injection LB ISB in the preoperative area only by faculty who are part of the regional anesthesia division. The injectate will include liposomal bupivacaine 10ml (133mg) mixed with bupivacaine HCl 0.5% 10 ml.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Anthony T Machi, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-11
Primary Completion
2022-12-12
Completion
2022-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816982 on ClinicalTrials.gov