Sciatic Nerve Block, Adductor Canal Block, or IPACK Block

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05684107

Collaborator

(none)

150

Enrollment

Location

Arms

Anticipated Duration (Months)

11.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Procedure: IPACK block Procedure: adductor canal block Procedure: sciatic nerve block	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Femoral Nerve Block Combined With Sciatic Nerve Block Adductor Canal Block Or (Interspace Between The Popliteal Artery And The Capsule Of The Posterior Knee) IPACK Block For Postoperative Analgesia After Major Knee Surgeries

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IPACK block	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artery, negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
Active Comparator: sciatic nerve block	Procedure: 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
Active Comparator: adductor canal block	Procedure: 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

Arm

Intervention/Treatment

Active Comparator: IPACK block

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

Active Comparator: sciatic nerve block

Procedure: 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

Active Comparator: adductor canal block

Procedure: 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

Outcome Measures

Primary Outcome Measures

change of visual analogue scale [change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement]
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

Secondary Outcome Measures

time for fisrt analgesic request [up to 48 hours]
when VAS is 4 or more longer time means a better outcome
total morphine consumption [up to 48 hours]
intraoperative and post operative higher consumption means a worse outcome

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, University Hospitals	Shibīn Al Kawm	Menoufia	Egypt	32511

Sponsors and Collaborators

Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mostafa saieed fahim mansour, lecturer, Menoufia University

ClinicalTrials.gov Identifier:

NCT05684107

Other Study ID Numbers:

10/2022ANETH2

First Posted:

Jan 13, 2023

Last Update Posted:

Jan 13, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by mostafa saieed fahim mansour, lecturer, Menoufia University

IPACK , Sciatic nerve block , adductor canal block

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Jan 13, 2023