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

NCT03816982 | Completed

• 1 other identifier: STU 082018-017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Median pain score on POD1

  Median pain score on POD1 as measured by the MBPI Short Form

  24 hours

Secondary Outcomes (1)

• Cumulative Area under Curve median pain score on POD1-3

  72 hours

Study Arms (2)

Bupivacaine HCl/Bupivacaine CISB

ACTIVE COMPARATOR

23 patients will be enrolled to receive a single-injection bupivacaine HCL interscalene block with bupivacaine CISB added.

Procedure: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB

Liposomal Bupivacaine Added to Interscalene Block

EXPERIMENTAL

23 patients will be enrolled to receive a single-injection bupivacaine HCl interscalene block with liposomal bupivacaine added to same injection.

Procedure: Single-injection bupivacaine HCl plus liposomal bupivacaine

Interventions

Single-injection bupivacaine HCl plus liposomal bupivacaine PROCEDURE

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.

Liposomal Bupivacaine Added to Interscalene Block

Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB PROCEDURE

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

Bupivacaine HCl/Bupivacaine CISB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients ≥ 18 years
• Individuals presenting for major shoulder arthroscopy procedures at Ambulatory Services Center (Outpatient Surgery Center) -that include rotator cuff repair and biceps tenodesis
• Patient is able to provide informed consent to participate in the study.

You may not qualify if:

• Allergy to amide local anesthetic, liposomal bupivacaine or other medication involving liposomal formulation
• Preexisting neurological deficits involving or potentially involving the ipsilateral brachial plexus
• Preexisting contralateral vocal fold paralysis or recurrent laryngeal paralysis
• Psychiatric or cognitive disorders that could interfere with perioperative evaluation including drug or alcohol abuse
• Chronic pain conditions
• Preoperative opioid consumption greater than 20 mg oral morphine equivalent.
• Any contraindication to interscalene nerve block including any local disorder of the skin where blockade is to be performed which would prevent safe performance of the block
• Any coagulation abnormality which would be a contraindication for block placement
• Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum creatinine greater than 1.4 mg/dL
• Body mass index \>50
• Pregnancy
• Incarceration
• ASA classification greater than 3
• Inability to provide informed consent

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anthony T Machi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: A randomized prospective noninferiority trial to assess the difference, if any, in median pain scores between two block methods using bupivacaine HCl and/or Liposomal bupivacaine, with the catheter method or single shot administration.

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 25, 2019
• Study Start: October 11, 2019
• Primary Completion: December 12, 2022
• Study Completion: December 30, 2022
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)