Pain management technique for breast surgery
Serratus and Parasternal Infrapectoral Block for Breast Surgery. A Randomized Controlled Double Blinded Study to Measure Impact on Time to Hospital Discharge in an Outpatient Setting.
NA · Western University, Canada · NCT03708302
This study is testing if using special nerve blocks can help women have less pain and recover faster after breast surgery compared to just regular anesthesia.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Western University, Canada (other) |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT03708302 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of serratus and parasternal infrapectoral nerve blocks in managing postoperative pain for women undergoing breast surgery. It compares the addition of these regional anesthesia techniques to a placebo combined with general anesthesia. The goal is to enhance pain relief, reduce opioid consumption, and improve recovery outcomes, potentially leading to earlier hospital discharge. The study focuses on patients undergoing unilateral oncoplastic breast reduction, simple mastectomy, or lumpectomy procedures.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-80 years undergoing specific types of breast surgery at St. Joseph's Hospital.
Not a fit: Patients with chronic pain conditions or those on high doses of opioids may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and recovery for patients undergoing breast surgery.
How similar studies have performed: Other studies have shown promising results with similar regional anesthesia techniques, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London, Ontario
- St. Joseph's Hospital — London, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Abhijit Biswas, MD — London Health Sciences Center, Western University, London. Ontario. Canada
- Study coordinator: Abhijit Biswas, MD
- Email: abhijit.biswas@lhsc.on.ca
- Phone: +14168301696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Pain, Post-Op Complication, breast surgery, serratus plane block, parasternal infrapectoral block, simple mastectomy, oncoplastic reduction mammoplasty