What side effects are associated with this type of intervention?

Common side effects of local anesthetic blocks for breast pain, such as Serratus and Parasternal Infrapectoral Nerve Blocks, include local pain at the injection site, risk of infection, bleeding, and rare instances of nerve damage. Systemic side effects can include allergic reactions, toxicity symptoms like dizziness and tinnitus, and in severe cases, seizures or cardiac issues. Temporary numbness or weakness in the affected area may also occur.

What prior FDA approvals exist?

The FDA has approved various local anesthetics for pain management, including lidocaine and bupivacaine, which are commonly used in nerve blocks to inhibit nerve signal transmission and reduce pain. These anesthetics are often employed in procedures similar to the Serratus and Parasternal Infrapectoral Nerve Blocks for effective pain control following surgeries, such as breast surgery. These techniques are designed to improve recovery quality, decrease chronic pain risk, and reduce overall healthcare costs.

What other types of research exist?

Promising novel alternatives to Serratus and Parasternal Infrapectoral Nerve Blocks for breast pain management include the use of regional anesthesia techniques such as thoracic paravertebral blocks and pectoral nerve blocks (PECS I and II). These techniques are effective in providing pain relief, are relatively easy to perform, and have shown positive outcomes in clinical practice.

← Back to Search

Nerve Blocks for Breast Surgery Pain

N/A

Recruiting

Led By Abhijit Biswas, MD

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ASA I to III (American Society of Anesthesiologists Physical Status Classification System)

Undergoing bilateral breast reduction surgery

Must not have

Contraindication to regional anesthesia, e.g. coagulopathy

Contraindication to a component of multimodal analgesia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed, nerve blocks may cause discomfort at the injection site, bleeding or infection risks, and rarely nerve damage or breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

I am a woman aged between 18 and 70.

Select...

I am having a surgery that will not require an overnight stay.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot have regional anesthesia due to a bleeding disorder.

Select...

I am allergic or cannot take part of the pain management treatment.

Select...

I have nerve damage affecting movement or feeling in my chest area.

Select...

My BMI is over 35.

Select...

I have health issues that could interfere with the study's outcome assessment.

Select...

I am able to understand and give consent for my treatment.

Select...

I have an infection close to where I might get an injection.

Select...

I use more than 30 mg of oxycodone or its equivalent daily for chronic pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to hospital discharge.

Secondary study objectives

Cumulative Opioid consumption (in Intravenous Morphine equivalent).

Duration of Hospital stay in minutes.

Opioid-related side effects requiring treatment.

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Study GroupActive Control2 Interventions

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

Group II: Control GroupPlacebo Group2 Interventions

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

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for breast pain, such as Serratus and Parasternal Infrapectoral Nerve Blocks, work by administering local anesthetics to inhibit nerve signal transmission, effectively reducing pain. This mechanism is crucial for breast pain patients as it provides targeted pain relief directly at the source, minimizing the need for systemic medications like opioids, which can have significant side effects. By focusing on local pain management, these treatments can improve recovery quality, reduce the risk of chronic pain development, and enhance overall patient care.