Serratus and Parasternal Infrapectoral Block for Breast Surgery. (NCT03708302) | Clinical Trial Compass
UnknownNot Applicable
Serratus and Parasternal Infrapectoral Block for Breast Surgery.
Canada120 participantsStarted 2019-07-01
Plain-language summary
Effective pain control is important following breast surgery as it improves quality of recovery, decreases the risk of chronic pain development and reduction of overall health care cost. Current strategies of pain management for breast surgery include use of opioid medication or addition of regional anesthesia along with general anesthesia. Serratus block and parasternal infrapectoral blocks are newly developed fascial plane blocks that are technically easy to perform, effective and safe based on our daily clinical practice and published evidence. We are comparing the addition of serratus and parasternal infrapectoral nerve block with general anesthesia to a combination of placebo and general anesthesia for breast reduction surgery. We propose that this would result in an improved efficiency resulting in early hospital discharge and improve quality of patient care, following breast reduction surgery.
Who can participate
Age range
18 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* women aged 18-80 years
* ASA I to III (American Society of Anesthesiologists Physical Status Classification System)
* Undergoing unilateral oncoplastic breast reduction mammoplasty, simple mastectomy surgery, or lumpectomy at St. Joseph's Hospital.
* Day surgery procedures
Exclusion Criteria:
* Inability to understand or to provide consent
* Inability or unwillingness to comply with required follow-up assessments
* Psychiatric disorder affecting patient assessment
* Contraindication to regional anesthesia, e.g. coagulopathy
* Allergy to local anesthetic
* Chronic pain and/or chronic use of opioids with a daily use of over 30 mg oxycodone or equivalent per day
* Contraindication to a component of multimodal analgesia
* Preexisting neuropathy with motor or sensory deficits in the area of the anterolateral chest wall
* Infection near injection site
* Pregnancy
* BMI\>40
* Complication or adverse events unrelated to the study intervention that precludes evaluation of the primary and secondary outcomes.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.