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

Shoulder Pain Clinical Trial

Official title:

Effect of Adding an Intercostobrachial Nerve Block to an Interscalene Block on Postoperative Pain After Total Shoulder Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06042608
• Other study ID #: STU-2023-0163
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 15, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Lisa Gu
• Phone: 214-648-6400
• Email: lisa.gu[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: June 1, 2025
• Est. primary completion date: May 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Shoulder Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time spent in PACU (recovery room)		0-2 hours after surgery
Primary	amount of opioid pain medications required to control postoperative pain		0-3 days after surgery
Secondary	pain scores (1-10 out of 10)		0-3 days after surgery