Nerve Blocks for Breast Surgery Pain

Recruiting at 1 trial location

Overseen By Abhijit Biswas, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Western University, Canada

Must not be taking: Opioids

Disqualifiers: Psychiatric disorder, Coagulopathy, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods for managing pain after breast surgery. It compares two types of nerve blocks—serratus (also known as the bilateral serratus plane block) and parasternal infrapectoral blocks—with a placebo to determine their effectiveness in aiding recovery and reducing hospital stays. Women undergoing certain breast surgeries, such as reduction or lumpectomy, who do not have chronic pain or allergies to anesthetics, may qualify. The trial aims to discover better pain control methods that improve recovery and reduce opioid use. As an unphased trial, it allows patients to contribute to innovative pain management strategies that could enhance recovery experiences for future patients.

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 prior data suggests that these nerve block techniques are safe for breast surgery pain management?

Research has shown that both the serratus plane block and the parasternal infrapectoral block are generally safe for managing pain after breast surgery. Studies have found that the serratus plane block effectively reduces postoperative pain without causing harmful side effects.

Research indicates that the parasternal infrapectoral block also provides strong pain relief and aids recovery after surgery. Reports of negative side effects are absent, suggesting it is well-tolerated by patients.

Overall, these nerve blocks are considered safe and effective for managing pain in breast surgery. They are easy to perform, making them a reliable choice for controlling pain and improving recovery quality. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these nerve block techniques for breast surgery pain because they offer a potentially more precise and effective way to manage postoperative discomfort. Traditional pain management often relies heavily on opioids, which can have significant side effects and dependency issues. In contrast, these nerve blocks use targeted delivery of ropivacaine, a local anesthetic, to specific nerve areas, which may provide longer-lasting pain relief with fewer side effects. By directly blocking the pain pathways, these methods could reduce the need for systemic medications and improve recovery experiences for patients.

What evidence suggests that these nerve blocks are effective for breast surgery pain?

In this trial, participants will receive either a sham or active nerve block treatment to manage pain after breast surgery. Research has shown that certain nerve blocks, such as the serratus and parasternal infrapectoral blocks, can effectively manage pain. Specifically, studies indicate that the serratus block reduces pain and lessens the need for opioid painkillers after surgery, while also decreasing the risk of nausea and vomiting. When combined with other blocks, the parasternal infrapectoral block provides even better pain relief and aids in recovery. These procedures are easy to perform and considered safe, potentially leading to better pain control and faster recovery after breast surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Abhijit Biswas, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

Allergy to local anesthetic

Pregnancy

Psychiatric disorder affecting patient assessment

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bilateral parasternal infrapectoral block
• Bilateral serratus plane block

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

The pectoral nerve (PECS) block significantly reduced postoperative pain levels and the need for propofol during breast cancer surgery, indicating its efficacy in pain management.

However, the PECS block did not improve the overall quality of recovery (QoR) scores on the first postoperative day, suggesting that while it helps with immediate pain relief, other factors may influence recovery that are not captured by pain scores alone.

NCBI (Pubmed)

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. Kamiya, Y., Hasegawa, M., Yoshida, T., 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11952172/

Pectoral nerve block and pecto-intercostal fascial ... This study aimed to compare the analgesic efficacy of ultrasound-guided Pecs-PIFB with thoracic PVB in patients undergoing modified radical mastectomy (MRM).

2. withpower.com withpower.com/trial/phase-mastodynia-2-2019-bb46f

Nerve Blocks for Breast Surgery Pain This N/A medical study run by Western University, Canada is evaluating whether Bilateral parasternal infrapectoral block and Bilateral serratus plane block ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03708302

Serratus and Parasternal Infrapectoral Block for Breast ... Serratus block and parasternal infrapectoral blocks are newly developed fascial plane blocks that are technically easy to perform, effective and safe based on ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7201222/

Parasternal Intercostal Block Complementation Contributes ... The combination of PECS I block, SIPB, and PSI block provides superior pain relief and postoperative recovery for patients undergoing MRM.

5. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02432-w

Comparison of the effects of transversus thoracic muscle ... The aim of the current study is to compare the effects of transversus thoracic muscle plane block (TTMPB) and pecto-intercostal fascial plane block (PIFB) upon ...