Nerve Block for Postoperative Shoulder Pain

Overseen By Farzin Ahmed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must not be taking: Opioids, Liposomal anesthetics

Disqualifiers: Chronic pain, Pulmonary disease, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding an extra nerve block (a temporary numbing technique) to standard pain relief after shoulder surgery can reduce pain and the need for pain medication. Specifically, it examines how an intercostobrachial nerve block (a nerve block in the armpit area) might improve recovery after shoulder replacement surgery. Participants will receive either the active nerve block or a placebo to determine which is more effective. This trial suits those undergoing their first total shoulder replacement and planning to go home the same day after surgery. As an unphased trial, it offers a unique opportunity to contribute to understanding innovative pain management techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using opioids or have allergies to certain medications, you may not be eligible to participate.

What prior data suggests that this nerve block technique is safe for postoperative shoulder pain management?

Research has shown that using ultrasound to guide intercostobrachial nerve blocks is generally safe. This technique helps doctors achieve greater precision and reduces the risk of complications. Studies have found that this nerve block effectively relieves pain, such as the discomfort from a tight band used during some surgeries. Although some may worry about side effects, ultrasound enhances the procedure's safety and success. Overall, patients typically tolerate the intercostobrachial nerve block well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care, which usually involves an interscalene nerve block for shoulder pain, the intercostobrachial nerve block specifically targets the intercostobrachial nerve in the armpit area. Researchers are excited about this approach because it has the potential to enhance pain relief after shoulder surgery by providing targeted anesthesia in a different region than traditional methods. This could mean more comprehensive management of postoperative pain, potentially leading to improved patient comfort and faster recovery times.

What evidence suggests that adding an intercostobrachial nerve block could be effective for postoperative shoulder pain?

Research has shown that an intercostobrachial nerve block effectively relieves post-surgical pain. One study found that this nerve block can completely numb the area in most cases, significantly reducing pain. Another study demonstrated success in 90% of patients, proving its effectiveness. In this trial, participants will receive either an active intercostobrachial nerve block or a sham intercostobrachial nerve block, alongside the standard interscalene block. This approach appears promising for improving recovery and reducing the need for pain medication after shoulder surgeries. ^{1 5 6 7 8}

Who Is on the Research Team?

Farzin Ahmed

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with a BMI under 35 who are scheduled for primary total shoulder arthroplasty or reverse total shoulder arthroplasty and expect to go home the same day. They must be able to understand and agree to participate in the study.

Inclusion Criteria

You are capable of providing consent to participate in the study.

I am scheduled for a primary or reverse total shoulder replacement.

I expect to go home the same day as my surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an active or sham intercostobrachial nerve block in addition to the standard interscalene block for shoulder pain management

1 day

1 visit (in-person)

Follow-up

Participants are monitored for postoperative pain, recovery room stay time, and opioid pain medication requirement

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intercostobrachial Nerve Block

Trial Overview The study is testing if adding an intercostobrachial nerve block to the standard interscalene block can reduce pain, decrease recovery room time, and lower the need for opioid painkillers after shoulder replacement surgery.

How Is the Trial Designed?

Group I: Active intercostobrachial nerve block Active Control 1 Intervention

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.

Group II: Sham intercostobrachial nerve block Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

Published Research Related to This Trial

The anterior suprascapular nerve block (SSNB) provided slightly better pain control than the interscalene brachial plexus block (ISB) after shoulder surgery, with a mean pain level 0.32 units lower, while still being noninferior in effectiveness.

SSNB resulted in significantly less grip strength impairment, with 99% of patients maintaining unimpaired grip strength compared to only 49% in the ISB group, making SSNB a safer and more effective option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Suprascapular Nerve Block Versus Interscalene Brachial Plexus Block for Shoulder Surgery in the Outpatient Setting: A Randomized Controlled Patient- and Assessor-Blinded Trial. Wiegel, M., Moriggl, B., Schwarzkopf, P., et al.[2022]

The modified lateral approach for interscalene catheter placement in 700 patients resulted in a high success rate for anesthesia (97%) and effective postoperative pain relief (99%), indicating its efficacy for shoulder surgery.

The study reported low rates of complications, with only 0.7% experiencing local infections and minor neurologic issues observed in 2.4% of patients, while patient satisfaction averaged 9.6 out of 10, highlighting the safety and acceptability of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the lateral modified approach for continuous interscalene block after shoulder surgery. Borgeat, A., Dullenkopf, A., Ekatodramis, G., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12534738/

Landmark- vs Ultrasound-Guided Intercostobrachial Nerve ... Intercostobrachial nerve, performed at the level of the 3rd rib, can achieve complete sensory block in most cases and is effective in reducing ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03421522

Intercostobrachial Nerve Sparing to Reduce Post-Surgical ... A large, definitive trial is needed to establish whether nerve preservation techniques are effective in reducing post-surgical pain after breast cancer surgery.

3. trialx.com trialx.com/clinical-trials/listings/313997/evaluating-the-efficacy-of-pecs-ii-block-versus-axillary-ring-block-in-rotator-cuff-repair-patients/

Evaluating the Efficacy of PECS II Block Versus Axillary ... Our primary outcome is pain score at 6 hours following the block. Eligibility. Inclusion Criteria: medically optimized patients who will undergo ...

4. journals.lww.com journals.lww.com/ijpmr/fulltext/2024/34030/a_study_to_assess_the_effects_of.5.aspx

A Study to Assess the Effects of Intercostobrachial Nerve... Post hoc Bonferroni analyses observed that there was a significant difference between the baseline, 1-week (P < 0.001) and 4-week (P = 0.001) QD scores, whereas ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3141149/

A randomized comparative study of efficacy of axillary and ... Successful block was achieved in 90% of the patients in group I and in 87% of patients in group A. Intercostobrachial nerve blockade was significantly higher in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10439685/

Comparison of the Effect of Intercostobrachial Nerve Block ... The pain caused by a tourniquet can be managed by ICBN block during hand and forearm surgery. It is recommended to use US guidance for more success and safety.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0748798302914095

Long term results of a randomised prospective study ... At 4 and 9 months after surgery, incidence of chronic painful symptoms not present preoperatively was 68% and 63%, respectively.

8. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06042608?keyword=%22Postoperative%20Pain%2C%20Acute%22

Evaluating Intercostobrachial Nerve Block's Effect on Pain ... Interscalene blocks are frequently performed to decrease postoperative pain after shoulder surgeries and are considered the gold standard for pain control ...