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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral block | Experimental | Preoperative paravertebral block on the side of mastectomy in addition to usual analgesia. |
|
| Usual analgesia | Active Comparator | Usual analgesia, as per anesthesiologist's preferences. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of postoperative pain using the BPI | Postoperative pain will be measured using the Brief Pain Inventory (BPI) | 24 hours, 28 hours, 72 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total use of opioids received intraoperatively. | Total dose of narcotics received intraoperatively (in mg morphine equivalent) | within 3 months after surgery |
| Use of non-opioid analgesia intraoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Charles Hogue | Contact | 418-525-4444 | jean-charles.hogue@crchudequebec.ulaval.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Quebec - Universite Laval | Recruiting | Québec | Quebec | G1H5B8 | Canada |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Usual analgesia | Procedure | The patient will receive analgesia as per the anesthesiologist's preferences. |
|
Analgesics other than opioids used intraoperatively
| During surgery |
| Total dose of opioids received in the PACU | Total dose of narcotics received in the post-anesthesia care unit (PACU) (in mg morphine equivalent) | During PACU stay |
| Time before first opioid | Time to first opioid dose after surgery | Within 3 months after surgery |
| Total opioids consumed in the 48 hours following surgery | Total quantity of opioids consumed in the 48 hours following surgery (in morphine equivalent) | Within 48 hours after surgery |
| Chronic pain | Presence of chronic pain at the surgical site at 3 months | At 3 months after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |