Nerve Blocks for Breast Surgery Pain

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Abhijit Biswas, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Western University, Canada

Must not be taking: Opioids

Disqualifiers: Psychiatric disorder, Coagulopathy, Allergy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests new methods to improve pain management and recovery for patients undergoing breast surgery. The goal is to reduce pain, potentially leading to quicker hospital discharge and better overall patient care.

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 use opioids daily over 30 mg of oxycodone or equivalent, you may not be eligible to participate.

What data supports the effectiveness of this treatment for breast surgery pain?

Research shows that combining different nerve blocks, like the serratus plane block and parasternal block, can effectively reduce pain after breast surgery. These blocks target specific nerves to provide better pain relief in areas that are often difficult to manage with other methods. ^{1 2 3 4 5}

Is the nerve block treatment for breast surgery pain generally safe for humans?

The nerve block treatments, such as the Pecto-intercostal Fascial Block (PIFB) and Serratus Plane Block (SPB), have been used in various surgeries and are generally considered safe when performed under ultrasound guidance, which helps ensure accurate placement and reduces risks. ^{1 2 3 6 7}

How does the nerve block treatment for breast surgery pain differ from other treatments?

This treatment is unique because it uses nerve blocks like the Parasternal Block (PSB) and Thoracic Transversus Plane Block (TTP) to specifically target and relieve pain in the internal mammary region, which other common nerve blocks like the Pectoral Nerve Block (PECS) and Serratus Plane Block (SPB) do not effectively address. ^{1 2 4 8 9}

Research Team

Abhijit Biswas, MD

Principal Investigator

London Health Sciences Center, Western University, London. Ontario. Canada

Eligibility Criteria

This trial is for women aged 18-70, with a physical status classified as ASA I to III, undergoing bilateral breast reduction surgery as a day procedure. It's not specified who can't join the trial.

Inclusion Criteria

I am undergoing or have undergone day surgery procedures.

I am in good to moderate health with or without severe systemic disease.

I am having surgery to reduce the size of both my breasts.

Exclusion Criteria

Pregnancy

Allergy to local anesthetic

Psychiatric disorder affecting patient assessment

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Management

Participants receive preoperative ultrasound-guided nerve blocks and standard monitoring

1 day

1 visit (in-person)

Intraoperative Management

Participants undergo surgery with standardized general anesthesia and nerve blocks

1 day

Postoperative Management

Participants receive postoperative pain management and are monitored for recovery

24-48 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain and recovery assessments

6 months

Follow-up meeting at 6 months post-surgery

Treatment Details

Interventions

• Bilateral parasternal infrapectoral block (Procedure)
• Bilateral serratus plane block (Procedure)

Trial Overview The study is testing two types of nerve blocks—serratus plane block and parasternal infrapectoral block—against placebo, all in combination with general anesthesia for breast reduction surgery. The goal is to see if these blocks improve recovery and reduce hospital stay.

Participant Groups

Group I: Study Group Active Control 2 Interventions

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.5% ropivacaine.

Group II: Control Group Placebo Group 2 Interventions

Ultrasound guided unilateral serratus plane block and unilateral parasternal infrapectoral block with 0.9% saline.

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Dr. Robin Farias-Eisner

Western University, Canada

Chief Executive Officer since 2022

PhD in Molecular Biology from UCLA, MD from the Royal College of Surgeons in Dublin, MBA from Pepperdine University

James Tweedy

Western University, Canada

Chief Medical Officer since 2020

MBA from Trinity Western University

Findings from Research

A case study of a 60-year-old man with persistent post-thoracotomy pain showed that using Parasternal Block (PSB) and Thoracic Transversus Plane Block (TTP) effectively eliminated pain in the internal mammary region after previous treatments with Pectoral Nerves Block (PECS) and Serratus Plane Block (SPB).

The pain relief achieved with PSB and TTP, combined with hydrodissection using triamcinolone and Ropivacaine, was sustained for at least 3 months, suggesting this approach could be a valuable option for managing residual pain in similar patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Guided Transversus Thoracic Plane block, Parasternal block and fascial planes hydrodissection for internal mammary post thoracotomy pain syndrome. Piraccini, E., Biondi, G., Byrne, H., et al.[2019]

The addition of the pectointercostal fascial plane block (PIFB) to the ultrasound-guided serratus anterior plane block (SAPB) significantly reduced the need for intraoperative fentanyl and resulted in lower mean arterial blood pressure and heart rate during surgery, indicating improved hemodynamic stability.

Despite these benefits, both groups showed similar postoperative pain scores and opioid consumption, suggesting that while PIFB may enhance intraoperative analgesia, it does not significantly impact overall postoperative pain management compared to SAPB alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesic Effect of Addition of Pectointercostal Block to Serratus Anterior Plane Block in Breast Surgeries: A Randomized, Controlled Trial. Hozien, AI., Helmy, AM., Koptan, HM., et al.[2023]

The serratus-intercostal plane block (SIPB) provides effective perioperative analgesia for patients undergoing partial mastectomy, with sensory loss extending over multiple intercostal spaces for 12 to 24 hours after administration.

In a study involving more than 20 patients, SIPB did not result in sensory loss at the T1 dermatomal distribution, indicating that additional analgesic methods may be necessary when performing axillary dissection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Serratus-Intercostal Plane Block for Brest Surgery]. Ohgoshi, Y., Yokozuka, M., Terajima, K.[2018]

In a study of 61 women undergoing modified radical mastectomy, the combination of pectoral nerve block I (PECS I) and serratus-intercostal plane block (SPB) significantly reduced pain scores and opioid consumption compared to general anesthesia alone.

Patients receiving the PECS I + SPB treatment reported better sleep quality and higher satisfaction with pain relief, indicating that this multimodal analgesic strategy enhances postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Pectoral Nerve Block I and Serratus-Intercostal Plane Block Alleviate Postoperative Pain in Patients Undergoing Modified Radical Mastectomy. Wang, W., Song, W., Yang, C., et al.[2020]

In a study of 40 female patients undergoing radical mastectomy, the ultrasound-guided serratus anterior plane block (SAPB) provided significantly longer-lasting pain relief compared to the thoracic paravertebral block (TPVB), with patients in the SAPB group waiting an average of 255.3 minutes for their first rescue analgesia versus 146.8 minutes for the TPVB group.

Patients receiving SAPB also consumed less total analgesics (diclofenac) in the first 24 hours and reported lower postoperative pain scores, along with a reduced incidence of postoperative nausea and vomiting (PONV), indicating that SAPB is a safer and more effective option for managing post-surgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of serratus anterior plane block versus thoracic paravertebral block for postoperative analgesia after breast cancer surgery - a randomized trial. Arora, S., Ovung, R., Bharti, N., et al.[2022]

In a study of 108 patients undergoing open cardiac surgery, those who received bilateral Pecto-intercostal Fascial Block (PIFB) experienced significantly less postoperative pain and required less pain medication compared to those who did not receive the block.

The PIFB group also had faster recovery times, including shorter ICU stays and overall hospital stays, along with lower levels of insulin and inflammatory markers three days post-surgery, indicating improved recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of bilateral Pecto-intercostal Fascial Block for perioperative pain management in patients undergoing open cardiac surgery: a prospective randomized study. Zhang, Y., Gong, H., Zhan, B., et al.[2022]

In a study involving 39 cardiac surgery patients, both the bilateral pectointercostal fascial block (PIFB) and transversus thoracic muscle plane block (TTMPB) were found to be equally effective in reducing morphine consumption and pain scores within the first 24 hours post-surgery.

However, patients receiving the PIFB experienced a longer time before their first request for analgesia compared to those receiving TTMPB, suggesting that while both techniques are effective, PIFB may provide a delayed onset of pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Ultrasound-Guided Pecto-intercostal Fascial Block and Transversus Thoracic Muscle Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery: A Prospective, Randomized, Double-Blind Pilot Study. Kaya, C., Dost, B., Dokmeci, O., et al.[2022]

In a study involving 64 women undergoing unilateral modified radical mastectomy, the pectoralis-serratus interfascial plane block resulted in higher postoperative morphine consumption and a shorter time to first analgesic request compared to the thoracic paravertebral block, indicating it may not be as effective for pain management.

While both techniques provided low pain intensity in the early postoperative hours, the thoracic paravertebral block showed significantly better pain control at 8, 16, and 24 hours post-surgery, suggesting it is the superior option for managing postmastectomy pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pectoralis-serratus interfascial plane block vs thoracic paravertebral block for unilateral radical mastectomy with axillary evacuation. Hetta, DF., Rezk, KM.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Ultrasound Guided Transversus Thoracic Plane block, Parasternal block and fascial planes hydrodissection for internal mammary post thoracotomy pain syndrome. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Analgesic Effect of Addition of Pectointercostal Block to Serratus Anterior Plane Block in Breast Surgeries: A Randomized, Controlled Trial. [2023]

3. Japan pubmed.ncbi.nlm.nih.gov

[Serratus-Intercostal Plane Block for Brest Surgery]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Pectoral Nerve Block I and Serratus-Intercostal Plane Block Alleviate Postoperative Pain in Patients Undergoing Modified Radical Mastectomy. [2020]

5. Brazil pubmed.ncbi.nlm.nih.gov

Efficacy of serratus anterior plane block versus thoracic paravertebral block for postoperative analgesia after breast cancer surgery - a randomized trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Effects of bilateral Pecto-intercostal Fascial Block for perioperative pain management in patients undergoing open cardiac surgery: a prospective randomized study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Comparison of Ultrasound-Guided Pecto-intercostal Fascial Block and Transversus Thoracic Muscle Plane Block for Acute Poststernotomy Pain Management After Cardiac Surgery: A Prospective, Randomized, Double-Blind Pilot Study. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Pectoralis-serratus interfascial plane block vs thoracic paravertebral block for unilateral radical mastectomy with axillary evacuation. [2022]