Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery

Lower Limb Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830630
• Other study ID #: 36264PR174/4/23
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2024
• Source: Tanta University
• Contact: Osama M Rehab, MD
• Phone: 00201095210806
• Email: osamarehab[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lower Limb Amputation
• Methylene Blue

Intervention

Drug:
• Bupivacaine methylene blue
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
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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of stump pain	Incidence of stump pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery	9 months after surgery
Other	Postoperative opioid consumption	Morphine consumption in the 1st 3 days after surgery will be recorded	3 days after surgery
Primary	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	Incidence of phantom limb pain	Incidence of phantom limb pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery	9 months after surgery