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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06042608
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Texas Southwestern Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Farzin Ahmed
Principal Investigator Affiliation [email protected]
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Postoperative Pain, Acute, Shoulder Pain
Arms & Interventions

Arms

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.

Interventions

Procedure: - intercostobrachial nerve block

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dallas, Texas

Status

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

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