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

Overview

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.

Full Title of Study: “Effect of Adding an Intercostobrachial Nerve Block to an Interscalene Block on Postoperative Pain After Total Shoulder Arthroplasty”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Care Provider)
• Study Primary Completion Date: November 1, 2024

Interventions

• Procedure: intercostobrachial nerve block
  • injection of local anesthetic to target the intercostobrachial nerve in the axilla

Arms, Groups and Cohorts

• Active Comparator: 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.
• Placebo Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

• time spent in PACU (recovery room)
  • Time Frame: 0-2 hours after surgery
• amount of opioid pain medications required to control postoperative pain
  • Time Frame: 0-3 days after surgery

Secondary Measures

• pain scores (1-10 out of 10)
  • Time Frame: 0-3 days after surgery

Participating in This Clinical Trial

Inclusion Criteria

• Adult patients 18-70 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • University of Texas Southwestern Medical Center
• Provider of Information About this Clinical Study
  • Principal Investigator: Lisa Gu, Assistant Professor – University of Texas Southwestern Medical Center
• Overall Contact(s)
  • Lisa Gu, 214-648-6400, lisa.gu@utsouthwestern.edu