Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery

What Was Tested

In this not phased trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Bupivacaine methylene blue group (experimental) and Bupivacaine saline group (active comparator).

The registry classes the interventions as drug.

More on the Plan

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 Took Part

72 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: patients with a history of allergy to local anesthetics; patients with allergy to methylene blue; anticoagulant use or coagulopathy.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

It started in 2023-05-01 with completion listed for 2027-02-01.

It ran at 1 site in Egypt.

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Degree of postoperative pain (time frame: 3 days after surgery).

It also tracked 1 secondary outcome, for example Incidence of phantom limb pain.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 72 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.