About this trial
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
This trial does not accept healthy volunteersQualifiers
18-70 years of age
woman scheduled for unilateral mastectomy with immediate reconstruction
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Paravertebral block
Procedure/SurgeryAn ultrasound-guided technique will be used to inject a volume of 40 mL of ropivacaine 0.2%, up to a maximum of 1.5 mg/kg, into the paravertebral space between the T3 and T4 vertebrae.
Usual analgesia
Procedure/SurgeryThe patient will receive analgesia as per the anesthesiologist's preferences.
Treatment groups
Trial outcomes
Primary outcomes
Evaluation of postoperative pain using the BPI
Postoperative pain will be measured using the Brief Pain Inventory (BPI)
Secondary outcomes
Total use of opioids received intraoperatively.
Total dose of narcotics received intraoperatively (in mg morphine equivalent)
Use of non-opioid analgesia intraoperatively
Analgesics other than opioids used intraoperatively
Total dose of opioids received in the PACU
Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent)
Time before first opioid
Time to first opioid dose after surgery
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