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Search / Trial NCT03708302

Serratus and Parasternal Infrapectoral Block for Breast Surgery.

Launched by WESTERN UNIVERSITY, CANADA · Oct 12, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Breast Surgery Serratus Plane Block Parasternal Infrapectoral Block Simple Mastectomy Oncoplastic Reduction Mammoplasty

ClinConnect Summary

This clinical trial is studying two new methods of pain management for women undergoing breast surgery, specifically focusing on how well these methods can help control pain after the procedure. The trial compares the effectiveness of two specific nerve blocks, called the serratus and parasternal infrapectoral blocks, combined with general anesthesia, to a combination of a placebo and general anesthesia. The goal is to see if using these nerve blocks can help patients recover faster, reduce pain, and improve their overall experience in the hospital.

Women aged 18 to 80 who are having certain types of breast surgeries at St. Joseph's Hospital, such as breast reduction or lumpectomy, may be eligible to participate. To join the trial, participants must be in good health and able to understand and follow instructions. Those with certain health conditions or allergies, as well as those who are pregnant or significantly overweight, cannot take part in the study. Participants can expect to receive either the new pain management technique or a placebo during their surgery and will be monitored to see how well it works. Overall, this trial aims to improve care for women undergoing breast surgery and assist them in having a more comfortable recovery.

Gender

FEMALE

Eligibility criteria

  • 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.

About Western University, Canada

Western University, located in Canada, is a leading research institution committed to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its faculty and research teams to conduct high-quality studies that address pressing medical challenges. Western University is dedicated to fostering a culture of ethical research practices, ensuring participant safety, and generating impactful findings that contribute to evidence-based medicine and improve patient outcomes. Through its robust infrastructure and commitment to excellence, Western University plays a vital role in the field of clinical research.

Locations

London, Ontario, Canada

London, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Abhijit Biswas, MD

Principal Investigator

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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