Pain management after mastectomy with reconstruction
Comparison Between Paravertebral Block and Usual Analgesia in Patients Undergoing Unilateral Total Mastectomy With Immediate Reconstruction
NA · CHU de Quebec-Universite Laval · NCT06276257
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | CHU de Quebec-Universite Laval (other) |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT06276257 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-70 scheduled for unilateral mastectomy with immediate reconstruction.
Not a fit: Patients undergoing axillary dissection or those with severe hepatic or kidney issues may not benefit from this study.
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 performed: Previous studies have shown that regional anesthesia techniques like paravertebral blocks can effectively reduce postoperative pain, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Québec, Quebec
- 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
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: Postoperative Pain