Perineural Methylene Blue Infusion in Lower Limb Amputation Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanta University
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Patients with a history of allergy to local anesthetics.
Patients with allergy to methylene blue.
Anticoagulant use or coagulopathy.
Trial design
Design model
Parallel
Treatments tested in this trial
Bupivacaine methylene blue
DrugPatients 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
DrugPatients 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
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Bupivacaine methylene blue groupExperimental treatment 1 intervention
Group B: Bupivacaine saline groupActive comparator 1 intervention
Trial outcomes
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)
Time frame
3 days after surgerySecondary outcomes
1
Incidence of phantom limb pain
Incidence of phantom limb pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery
Time frame
9 months after surgeryOther outcomes
1
Incidence of stump pain
Incidence of stump pain at day 6 after surgery then at 1, 3, 6, 9 months after surgery
Time frame
9 months after surgery2
Postoperative opioid consumption
Morphine consumption in the 1st 3 days after surgery will be recorded
Time frame
3 days after surgerySponsors and contacts
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Source ClinicalTrials.gov