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This prospective randomized controlled study will be conducted to evaluate the analgesic effect of continuous perineural infusion of methylene blue with bupivacaine on acute postoperative pain and to evaluate its preventive role against chronic phantom pain in patients undergoing lower limb amputation surgery
Post amputation pain remains an extremely challenging pain condition to treat, so the prevention of phantom pain is our goal to decrease its incidence.
Methylene blue, an inhibitor of nitric oxide synthase and guanylate cyclase, has been widely applied for a variety of pain-related diseases due to its characteristic abilities, such as the blocking of pain transmission, antioxidant, and anti-inflammatory effects. Methylene blue can maintain local anesthesia for approximately 20 days so it can be used as a nerve block to relieve pain, especially refractory neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine methylene blue group | Experimental | Patients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml methylene blue 1% (10 mg) plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of methylene blue plus bupivacaine 0.25% (1 ml of methylene blue added to each 49 ml of bupivacaine 0.25%) will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively |
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| Bupivacaine saline group | Active Comparator | Patients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml normal saline plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of bupivacaine 0.25% will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine methylene blue | Drug | Patients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml methylene blue 1% (10 mg) plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of methylene blue plus bupivacaine 0.25% (1 ml of methylene blue added to each 49 ml of bupivacaine 0.25%) will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of postoperative pain | Degree of postoperative pain will be assessed using visual analogue scale which is a 10 cm scale ranging from (0 = no pain to 10 = worst possible pain) | 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of phantom limb pain | Incidence of phantom limb pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery | 9 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of stump pain | Incidence of stump pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery | 9 months after surgery |
| Postoperative opioid consumption | Morphine consumption in the 1st 3 days after surgery will be recorded |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Osama M Rehab, MD | Contact | 00201095210806 | osamarehab@med.tanta.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University | Recruiting | Tanta | Gharbia Governorate | 31527 | Egypt |
The data will be available upon a reasonable request from the corresponding author
The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year
The data will be available upon a reasonable request from the corresponding author
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Open Label
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| bupivacaine saline | Drug | Patients in this group will receive the following regimen through the perineural catheter: Bolus dose of 1 ml normal saline plus 19 ml bupivacaine 0.25% will be given intraoperatively before wound closure, and perineural infusion of bupivacaine 0.25% will be started in the recovery room at a rate of 2-5 ml/hour for 72 hours postoperatively |
|
| 3 days after surgery |