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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05684107
Other study ID # 10/2022ANETH2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date December 1, 2023

Study information

Verified date January 2023
Source Menoufia University
Contact mostafa saieed saieed mansour, MD
Phone 01225484055
Email mostafa.said@med.menofia.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria: - ASA I or II physical status - undergoing elective major knee surgery Exclusion Criteria: - refusal of the patients to give informed consent, - preexisting coagulation disorders, - known allergies to aminoamide local anesthetics, - local infection at the site of the block, - morbid obesity, - hepatic and renal diseases - patients with psychological disorders

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
IPACK block
the probe is applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe is slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared. a spinal needle 22G x 3.5 inches is advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reached the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
adductor canal block
the transducer is placed anteromedially, approximately at the junction between the middle and distal third of the thigh or somewhat lower. The saphenous nerve block should be performed at the most distal level where the artery still lies immediately deep to the sartorius muscle, thus minimizing the amount of motor nerve block of the vastus medialis; an adductor canal nerve block is typically performed more proximally, around the mid-thigh level. The needle is inserted in-plane in a lateral-to-medial orientation and advanced toward the femoral artery. Once the needle tip is visualized anterior to the artery and after careful aspiration, 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
sciatic nerve block
patient in a supine position with the hip and knee on the operated side flexed and the leg externally rotated at approximately 45 degrees. The ultrasound transducer is first positioned perpendicular to the skin approximately 8 cm distal to the inguinal crease. The location is then scanned by sliding and tilting the transducer until a clear transverse image of the hyperechoic sciatic nerve located posterior and medial to the lesser trochanter is obtained. a spinal needle 22G x 3.5 inches is advanced parallel and in line with the ultrasound transducer while the sciatic nerve is kept in the middle of the screen. The needle is advanced slowly under real-time ultrasound guidance until it is near the nerve then negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn

Locations

Country Name City State
Egypt Faculty of Medicine, University Hospitals Shibin Al Kawm Menoufia

Sponsors (1)

Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary change of visual analogue scale a scale from 0 to 10 as the patient will be asked to express his pain on the scale higher scale means a worse outcome change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement
Secondary time for fisrt analgesic request when VAS is 4 or more longer time means a better outcome up to 48 hours
Secondary total morphine consumption intraoperative and post operative higher consumption means a worse outcome up to 48 hours
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