Clinical trial
The Preventive Value of Continuous Perineural Methylene Blue Infusion in Patients Undergoing Lower Limb Amputation Surgery
Name
36264PR174/4/23
Description
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
Trial arms
Trial start
2023-05-01
Estimated PCD
2024-05-01
Trial end
2024-05-01
Status
Recruiting
Treatment
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
Arms:
Bupivacaine methylene blue group
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
Arms:
Bupivacaine saline group
Size
72
Primary endpoint
Degree of postoperative pain
3 days after surgery
Eligibility 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open Label'}}, 'enrollmentInfo': {'count': 72, 'type': 'ESTIMATED'}}
Updated at
2024-05-08
1 organization
1 product
3 indications
Organization
Tanta UniversityProduct
BupivacaineIndication
PerineuralIndication
Methylene BlueIndication
Lower Limb Amputation