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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
Awards & highlights
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 belowSelect...
I am in good to moderate health with or without severe systemic disease.
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I am having surgery to reduce the size of both my breasts.
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I am a woman aged between 18 and 70.
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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.
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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
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 moreTrial 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.
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.
Find a Location
Who is running the clinical trial?
Western University, CanadaLead Sponsor
251 Previous Clinical Trials
53,589 Total Patients Enrolled
Abhijit Biswas, MDPrincipal InvestigatorLondon Health Sciences Center, Western University, London. Ontario. Canada
1 Previous Clinical Trials
200 Total Patients Enrolled
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