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

NCT ID: NCT06042608

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active intercostobrachial nerve block

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.

Group Type: ACTIVE_COMPARATOR

intercostobrachial nerve block

Intervention Type: PROCEDURE

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

Sham intercostobrachial nerve block

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.

Group Type: PLACEBO_COMPARATOR

intercostobrachial nerve block

Intervention Type: PROCEDURE

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

Interventions

intercostobrachial nerve block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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)
• Allergy or intolerance to any medication in the protocol
• Body mass index >35
• Pregnancy
• Incarceration
• ASA classification greater than 3
• Inability to provide informed consent
• Refusal to participate in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lisa Gu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Farzin Ahmed

Role: STUDY_DIRECTOR

farzin.ahmed@utsouthwestern.edu

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2023-0163

Identifier Type: -

Identifier Source: org_study_id