Clinical trial NCT06042608: Evaluating Intercostobrachial Nerve Block's Effect on Pain Control After Shoulder Replacement
Official title: Effect of Adding an Intercostobrachial Nerve Block to an Interscalene Block on Postoperative Pain After Total Shoulder Arthroplasty
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Postoperative Pain, Acute
Shoulder Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* 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

Primary outcomes:
measure: time spent in PACU (recovery room)
timeFrame: 0-2 hours after surgery
measure: amount of opioid pain medications required to control postoperative pain
timeFrame: 0-3 days after surgery
Secondary outcomes:
measure: pain scores (1-10 out of 10)
timeFrame: 0-3 days after surgery
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: farzin.ahmed@utsouthwestern.edu
name: Farzin Ahmed
role: STUDY_DIRECTOR
References: