Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery

Tanta University72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Perineural Methylene Blue Lower Limb Amputation

Interventions

Bupivacaine methylene blueDRUG

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

bupivacaine salineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of both genders, suffering from vascular insufficiency of one or both lower limbs and scheduled for above or below knee amputation under general anesthesia. Exclusion Criteria: * Patients with a history of allergy to local anesthetics. * Patients with allergy to methylene blue. * Anticoagulant use or coagulopathy.

Locations (1)

Tanta University

Tanta, Gharbia Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 3 days after surgery

Secondary Outcomes

Incidence of phantom limb pain

Incidence of phantom limb pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery

Time frame: 9 months after surgery

Central Contacts

Osama M Rehab, MD

CONTACT

00201095210806 osamarehab@med.tanta.edu.eg

Data from ClinicalTrials.gov

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