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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Invitation-only

Conditions

Shoulder Pain
Postoperative Pain, Acute

Treatments

Procedure: intercostobrachial nerve block

Study type

Interventional

Funder types

Other

Identifiers

NCT06042608
STU-2023-0163

Details and patient eligibility

About

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.

Enrollment

74 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

74 participants in 2 patient groups, including a placebo group

Active intercostobrachial nerve block
Active Comparator group
Description:
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.
Treatment:
Procedure: intercostobrachial nerve block
Sham intercostobrachial nerve block
Placebo Comparator group
Description:
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.
Treatment:
Procedure: intercostobrachial nerve block

Trial contacts and locations

1

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Central trial contact

Farzin Ahmed; Lisa Gu

Data sourced from clinicaltrials.gov

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