Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery

NCT05830630 | Recruiting

• 1 other identifier: 36264PR174/4/23
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Perineural; Methylene Blue; Lower Limb Amputation

Keywords

Perineural; Methylene blue; Lower limb amputation

Outcome Measures

Primary Outcomes (1)

• Degree of postoperative pain

  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)

  3 days after surgery

Secondary Outcomes (1)

• Incidence of phantom limb pain

  9 months after surgery

Other Outcomes (2)

• Incidence of stump pain

  9 months after surgery

• Postoperative opioid consumption

  3 days after surgery

Study Arms (2)

Bupivacaine methylene blue group

EXPERIMENTAL

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

Drug: Bupivacaine methylene blue

Bupivacaine saline group

ACTIVE COMPARATOR

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

Drug: bupivacaine saline

Interventions

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 methylene blue group

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

Bupivacaine saline group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Gharbia Governorate, 31527, Egypt

RECRUITING

Central Study Contacts

Osama M Rehab, MD

CONTACT

00201095210806; osamarehab@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesiology, surgical intensive care and pain medicine

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of study for 1 year
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)