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Study Group for Breast 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
day surgery procedures
ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study Summary

This trial is looking at two new methods of pain control for breast reduction surgery. They want to see if adding serratus and parasternal infrapectoral nerve blocks to general anesthesia is better than using

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.Check my eligibility
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.See study design
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
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I am undergoing or have undergone day surgery procedures.
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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 surgery to reduce the size of both my breasts.
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I am in good to moderate health with or without severe systemic disease.
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I am having a surgery that will not require an overnight stay.
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I am a woman aged between 18 and 70.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to hospital discharge.
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

Western University, CanadaLead Sponsor
239 Previous Clinical Trials
57,363 Total Patients Enrolled
Abhijit Biswas, MDPrincipal InvestigatorLondon Health Sciences Center, Western University, London. Ontario. Canada
1 Previous Clinical Trials
200 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being accepted for enrollment in this research study?

"According to the details on clinicaltrials.gov, this study is presently seeking potential participants. The trial was initially published on July 1st, 2019 and most recently revised on February 5th, 2024."

Answered by AI

Are individuals older than 35 years being considered for enrollment in this research study?

"Individuals aged between 18 and 70 years old are eligible for participation based on the specified age requirements of this clinical study."

Answered by AI

What is the current number of participants eligible for enrollment in this clinical research study?

"Indeed, the details on clinicaltrials.gov affirm that this particular trial is currently seeking eligible individuals. The trial was originally listed on July 1st, 2019 and last revised on February 5th, 2024. Recruitment aims to enlist 120 participants from a single designated site."

Answered by AI
~15 spots leftby Dec 2024