Paravertebral Block for Mastectomy with Immediate Reconstruction
- Conditions
- Postoperative Pain
- Interventions
- Procedure: Usual analgesiaProcedure: Paravertebral block
- Registration Number
- NCT06276257
- Lead Sponsor
- CHU de Quebec-Universite Laval
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 18-70 years of age
- woman scheduled for unilateral mastectomy with immediate reconstruction
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual analgesia Usual analgesia Usual analgesia, as per anesthesiologist's preferences. Paravertebral block Paravertebral block Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia.
- Primary Outcome Measures
Name Time Method Evaluation of postoperative pain using the BPI 24 hours, 28 hours, 72 hours after surgery Postoperative pain will be measured using the Brief Pain Inventory (BPI)
- Secondary Outcome Measures
Name Time Method Chronic pain At 3 months after surgery Presence of chronic pain at the surgical site at 3 months
Total opioids consumed in the 48 hours following surgery Within 48 hours after surgery Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent)
Use of non-opioid analgesia intraoperatively During surgery Analgesics other than opioids used intraoperatively
Time before first opioid Within 3 months after surgery Time to first opioid dose after surgery
Total use of opioids received intraoperatively. within 3 months after surgery Total dose of narcotics received intraoperatively (in mg morphine equivalent)
Total dose of opioids received in the PACU During PACU stay Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)
Trial Locations
- Locations (1)
CHU de Quebec - Universite Laval
🇨🇦Quebec City, Quebec, Canada