NCT06276257 Paravertebral Block for Mastectomy With Immediate Reconstruction
| NCT ID | NCT06276257 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Postoperative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-08-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Following a mastectomy, patients may develop chronic pain, called post-mastectomy pain syndrome (PMPS). This syndrome manifests itself as complex neuropathic pain that seems linked to nerve damage suffered either during surgery, during healing or by nervous system dysfunction. However, the exact pathophysiology remains unknown. Typically, the pain is located on the ipsilateral side of the surgery and projects to the anterior thorax to the lateral thorax and may affect the proximal part of the arm. This pain persists for more than three months following the procedure and has the characteristics of neuropathic pain: burning sensation, tingling, electric shock, hyperalgesia, etc. The prevalence of PMDS varies between 2% and 78%; this disparity comes from the fact that there are no clear criteria in the literature for making the diagnosis. One of the risk factors for developing PMDS is the presence of acute pain immediately postoperatively. The main objective of this study is to compare two analgesic modalities, namely BPV (study modality) and usual analgesia (control modality), in patients undergoing total mastectomy with immediate reconstruction under general anesthesia with the aim of to evaluate their functional pain score at 24, 48 and 72 hours following the surgical procedure.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06276257 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Postoperative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06276257 currently recruiting?
Yes, NCT06276257 is actively recruiting participants. Contact the research team at jean-charles.hogue@crchudequebec.ulaval.ca for enrollment information.
Where is the NCT06276257 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT06276257 clinical trial?
NCT06276257 is sponsored by CHU de Quebec-Universite Laval. The trial plans to enroll 60 participants.