search
Back to results

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

Primary Purpose

Postoperative Pain, Acute, Shoulder Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
intercostobrachial nerve block
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain, Acute

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Active intercostobrachial nerve block

    Sham intercostobrachial nerve block

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    time spent in PACU (recovery room)
    amount of opioid pain medications required to control postoperative pain

    Secondary Outcome Measures

    pain scores (1-10 out of 10)

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    September 15, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06042608
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Acute, Shoulder Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    74 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Active intercostobrachial nerve block
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Sham intercostobrachial nerve block
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    intercostobrachial nerve block
    Intervention Description
    injection of local anesthetic to target the intercostobrachial nerve in the axilla
    Primary Outcome Measure Information:
    Title
    time spent in PACU (recovery room)
    Time Frame
    0-2 hours after surgery
    Title
    amount of opioid pain medications required to control postoperative pain
    Time Frame
    0-3 days after surgery
    Secondary Outcome Measure Information:
    Title
    pain scores (1-10 out of 10)
    Time Frame
    0-3 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lisa Gu
    Phone
    214-648-6400
    Email
    lisa.gu@utsouthwestern.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs