Postoperative Pain
Conditions
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.
Interventions
PROCEDUREParavertebral block
An 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.
PROCEDUREUsual analgesia
The patient will receive analgesia as per the anesthesiologist's preferences.
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Use of non-opioid analgesia intraoperatively | During surgery | Analgesics other than opioids used intraoperatively |
| 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) |
| Total use of opioids received intraoperatively. | within 3 months after surgery | Total dose of narcotics received intraoperatively (in mg morphine equivalent) |
| 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) |
| Chronic pain | At 3 months after surgery | Presence of chronic pain at the surgical site at 3 months |
| Time before first opioid | Within 3 months after surgery | Time to first opioid dose after surgery |
Countries
Canada
Contacts
CONTACTJean-Charles Hogue
Outcome results
None listed