Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Using methylene blue to manage pain after lower limb amputation

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

Run by Tanta University · NCT05830630 · Data updated 2026-11-12

This study is testing if a combination of methylene blue and bupivacaine can help reduce pain after lower limb amputation and prevent long-term phantom pain for patients.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment72 (estimated)
SponsorTanta University
Academic / other
Locations1 site (Tanta, Gharbia Governorate)
StatusRecruiting
StartedMay 1, 2023
Main results expectedFebruary 1, 2027
Study endsNovember 1, 2027
Registry record updatedJuly 6, 2026
Trial IDNCT05830630 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients of both genders with vascular insufficiency scheduled for above or below knee amputation.

Probably not a fit

Patients with allergies to local anesthetics or methylene blue, or those on anticoagulants, may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of continuous perineural infusion of methylene blue combined with bupivacaine in reducing acute postoperative pain and preventing chronic phantom pain in patients undergoing lower limb amputation. It is a prospective randomized controlled trial that aims to address the challenging issue of post-amputation pain management. Methylene blue is known for its analgesic properties and ability to block pain transmission, making it a potential candidate for improving pain outcomes in this patient population.

Why it matters

Potential benefit: If successful, this approach could significantly reduce both acute and chronic pain for patients undergoing lower limb amputation.

How similar studies have gone: While the use of methylene blue in pain management is promising, this specific application in lower limb amputation is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Tanta University
    Tanta, Gharbia Governorate, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.