NCT05830630

Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery

The Preventive Value of Continuous Perineural Methylene Blue Infusion in Patients Undergoing Lower Limb Amputation Surgery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Perineural
• Methylene Blue
• Lower Limb Amputation

Interventions

Type	Name	Description
DRUG	Bupivacaine methylene blue	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
DRUG	bupivacaine saline	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

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-08-01
• Completion: 2027-05-01
• First posted: 2023-04-26
• Last updated: 2025-07-09

Locations

1 site across 1 country: Egypt