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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06042608

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain, Acute Shoulder Pain	Procedure: intercostobrachial nerve block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Procedure: intercostobrachial nerve block injection of local anesthetic to target the intercostobrachial nerve in the axilla
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.	Procedure: intercostobrachial nerve block injection of local anesthetic to target the intercostobrachial nerve in the axilla

Arm

Intervention/Treatment

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.

Procedure: intercostobrachial nerve block

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

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.

Procedure: intercostobrachial nerve block

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

pain scores (1-10 out of 10) [0-3 days after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lisa Gu, Assistant Professor, University of Texas Southwestern Medical Center

ClinicalTrials.gov Identifier:

NCT06042608

Other Study ID Numbers:

STU-2023-0163

First Posted:

Sep 18, 2023

Last Update Posted:

Sep 18, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shoulder Pain

Pain, Postoperative

Acute Pain

Study Results

No Results Posted as of Sep 18, 2023