Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05830630

Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Perineural Lower Limb Amputation Methylene Blue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

Location status: Recruiting

Location contact

Doha M Bakr, MD

SUB_INVESTIGATOR

Osama M Rehab, MD

CONTACT

[email protected]

00201095210806

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Degree of postoperative pain

    Time frame: 3 days after surgery

    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)

Secondary outcomes

  1. Incidence of phantom limb pain

    Time frame: 9 months after surgery

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

Other outcomes

  1. Incidence of stump pain

    Time frame: 9 months after surgery

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

  2. Postoperative opioid consumption

    Time frame: 3 days after surgery

    Morphine consumption in the 1st 3 days after surgery will be recorded

Study contacts

Contact information is provided by the study sponsor or research team.

Osama M Rehab, MD

CONTACT

[email protected]

00201095210806

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 26, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.