Using methylene blue to manage pain after lower limb amputation
The Preventive Value of Continuous Perineural Methylene Blue Infusion in Patients Undergoing Lower Limb Amputation Surgery
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Trial ID | NCT05830630 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients of both genders with vascular insufficiency scheduled for above or below knee amputation.
Not a fit: Patients with allergies to local anesthetics or methylene blue, or those on anticoagulants, may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Tanta, Gharbia Governorate
- Tanta University — Tanta, Gharbia Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Osama M Rehab, MD
- Email: osamarehab@med.tanta.edu.eg
- Phone: 00201095210806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.