Pain management after mastectomy with reconstruction
Official title: Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction
Run by CHU de Quebec-Universite Laval · NCT06276257 · Data updated 2026-11-12
This study tests if a special pain relief technique can help women feel less pain after having a mastectomy with reconstruction and reduce the chances of long-term pain problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Status | Recruiting |
| Started | August 5, 2024 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT06276257 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-70 scheduled for unilateral mastectomy with immediate reconstruction.
✕Probably not a fit
Patients undergoing axillary dissection or those with severe hepatic or kidney issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of a paravertebral block in managing postoperative pain in women undergoing unilateral mastectomy with immediate reconstruction. The focus is on reducing the incidence of post-mastectomy pain syndrome (PMPS), which can lead to chronic neuropathic pain. Participants will receive either the paravertebral block or usual analgesia to compare outcomes related to pain relief. The study seeks to identify the best approach to minimize acute pain immediately after surgery, potentially reducing the risk of developing PMPS.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and improve recovery for women undergoing mastectomy with reconstruction.
How similar studies have gone: Previous studies have shown that regional anesthesia techniques like paravertebral blocks can effectively reduce postoperative pain, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-70 years of age * woman scheduled for unilateral mastectomy with immediate reconstruction Exclusion Criteria: * Patients who will have an axillary dissection during surgery. * Woman with severe hepatic insufficiency (Child Pugh Classification B and above24). * Woman with kidney failure stage 4 and above25. * Body mass index (BMI) \> 40 kg/m2. * Woman with an allergy to local anesthetics. * Woman with a bleeding disorder in whom BPV is contraindicated. * Woman in whom stopping antiplatelet or anticoagulant therapy does not allow compliance with the standards of practice of neuraxial anesthesia issued by the American Society of Regional Anesthesia. * Woman with a single lung. * Pregnant woman.
Where it's running
-
CHU de Quebec - Universite Laval
Québec, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Jean-Charles Hogue
- Email: jean-charles.hogue@crchudequebec.ulaval.ca
- Phone: 418-525-4444
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.