RecruitingNot ApplicableNCT05830630

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


Sponsor

Tanta University

Enrollment

72 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • 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 Criteria3

  • Patients with a history of allergy to local anesthetics.
  • Patients with allergy to methylene blue.
  • Anticoagulant use or coagulopathy.

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Interventions

DRUGBupivacaine 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

DRUGbupivacaine 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


Locations(1)

Tanta University

Tanta, Gharbia Governorate, Egypt

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NCT05830630


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