Postoperative Pain, AcuteNCT06042608
Evaluating Intercostobrachial Nerve Block's Effect on Pain Control After Shoulder Replacement
A study testing intercostobrachial nerve block in people with Postoperative Pain, Acute and Shoulder Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Acute, Shoulder Pain
- What is being tested?
- intercostobrachial nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Effect of Adding an Intercostobrachial Nerve Block to an Interscalene Block on Postoperative Pain After Total Shoulder Arthroplasty
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.
- Conditions
- Postoperative Pain, Acute, Shoulder Pain
- Being tested
- intercostobrachial nerve block
- Medical subject headings
- Pain, Postoperative, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intercostobrachial nerve blockProcedure or surgery
injection of local anesthetic to target the intercostobrachial nerve in the axilla
| Study group | Role | What they receive |
|---|---|---|
| Active intercostobrachial nerve block | Active comparator | 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. Receives: Procedure: intercostobrachial nerve block |
| Sham intercostobrachial nerve block | Placebo comparator | 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. Receives: Procedure: intercostobrachial nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
time spent in PACU (recovery room)
Measured: 0-2 hours after surgery
amount of opioid pain medications required to control postoperative pain
Measured: 0-3 days after surgery
Secondary outcomes (1)
pain scores (1-10 out of 10)
Measured: 0-3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start10 Sep 2024
- Primary completion13 Dec 2024
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Gu, University of Texas Southwestern Medical Center
- Investigators
- Farzin Ahmed, Study director, farzin.ahmed@utsouthwestern.edu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042608
- Sponsor's protocol ID
- STU-2023-0163
- Status last verified
- Oct 2025
- First submitted
- 6 Sep 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding an Intercostobrachial Nerve Block to an Interscalene Block on Postoperative Pain After Total Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT06042608
- Acronym / sponsor ID
- STU-2023-0163
- Conditions
- Postoperative Pain, Acute, Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active intercostobrachial nerve block | Active comparator | Procedure: intercostobrachial nerve blockPatient 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. |
| Sham intercostobrachial nerve block | Placebo comparator | Procedure: intercostobrachial nerve blockPatient 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intercostobrachial nerve blockinjection of local anesthetic to target the intercostobrachial nerve in the axilla | Procedure or surgery | Active intercostobrachial nerve block, Sham intercostobrachial nerve block |
Primary outcome
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
1 secondary outcome
pain scores (1-10 out of 10)
Time frame: 0-3 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farzin Ahmed study director
farzin.ahmed@utsouthwestern.edu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intercostobrachial nerve block in people with Postoperative Pain, Acute and Shoulder Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time spent in PACU (recovery room) (time frame: 0-2 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.