Evaluating Intercostobrachial Nerve Block's Effect on Pain Control After Shoulder Replacement

NCT06042608 | Completed

• 1 other identifier: STU-2023-0163
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Interscalene blocks are frequently performed to decrease postoperative pain after shoulder surgeries and are considered the gold standard for pain control after this type of surgery. Some patients report pain in the axilla (armpit) following shoulder replacement surgeries. Sensation in the axilla is supplied by nerves not covered by the interscalene block. Sensation in the axilla can be decreased by performing an intercostobrachial nerve block. This study aims to study whether adding an intercostobrachial nerve block to the interscalene block decreases recovery room stay time, opioid pain medication requirement, and postoperative pain scores.

Conditions

Postoperative Pain, Acute; Shoulder Pain

Outcome Measures

Primary Outcomes (2)

• time spent in PACU (recovery room)

  0-2 hours after surgery

• amount of opioid pain medications required to control postoperative pain

  0-3 days after surgery

Secondary Outcomes (1)

• pain scores (1-10 out of 10)

  0-3 days after surgery

Study Arms (2)

Active intercostobrachial nerve block

ACTIVE COMPARATOR

Patient will receive local anesthetic injected around their intercostobrachial nerve in the axilla (armpit). They will still receive an active interscalene nerve block (gold standard) that helps with the rest of the shoulder pain.

Procedure: intercostobrachial nerve block

Sham intercostobrachial nerve block

PLACEBO COMPARATOR

Patient will receive saline injected around their intercostobrachial nerve in the axilla (armpit). This is a sham intercostobrachial nerve block because saline is not an active medication. They will still receive an active interscalene nerve block (gold standard) that helps with the rest of the shoulder pain.

Procedure: intercostobrachial nerve block

Interventions

intercostobrachial nerve block PROCEDURE

injection of local anesthetic to target the intercostobrachial nerve in the axilla

Active intercostobrachial nerve block; Sham intercostobrachial nerve block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 18-80 years old
• Adult patient's BMI \<= 35
• Individuals presenting for primary total shoulder arthroplasty or reverse total shoulder arthroplasty
• Anticipated discharge home same day of surgery
• Patient is able to provide informed consent to participate in the study.

You may not qualify if:

• Patient presenting for revision shoulder surgery
• 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 use
• Moderate to severe pulmonary disease
• Moderate to severe sleep apnea
• Planned postoperative admission.
• Unplanned postoperative admission
• Any contraindication to interscalene or intercostobrachial 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 CrCl \< 60
• Sulfa allergy (or other reason patient cannot receive celecoxib)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Shoulder Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Farzin Ahmed

  farzin.ahmed@utsouthwestern.edu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 18, 2023
• Study Start: September 10, 2024
• Primary Completion: December 13, 2024
• Study Completion: June 30, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)