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Clinical Trials/NCT06042608
NCT06042608
Completed
Not Applicable

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

University of Texas Southwestern Medical Center1 site in 1 country12 target enrollmentSeptember 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain, Acute
Sponsor
University of Texas Southwestern Medical Center
Enrollment
12
Locations
1
Primary Endpoint
time spent in PACU (recovery room)
Status
Completed
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2024
End Date
June 30, 2025
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Gu

Assistant Professor

University of Texas Southwestern Medical Center

Eligibility 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.

Outcomes

Primary Outcomes

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 Outcomes

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

Study Sites (1)

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