- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684107
Sciatic Nerve Block, Adductor Canal Block, or IPACK Block
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mostafa saieed saieed mansour, MD
- Phone Number: 01225484055
- Email: mostafa.said@med.menofia.edu.eg
Study Locations
-
-
Menoufia
-
Shibīn Al Kawm, Menoufia, Egypt, 32511
- Recruiting
- Faculty of Medicine, University Hospitals
-
Contact:
- Ghada Ali, MD
- Phone Number: 01001775783
- Email: ghadaali132@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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artery, negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn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
|
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
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change of visual analogue scale
Time Frame: 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
|
change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
time for fisrt analgesic request
Time Frame: up to 48 hours
|
when VAS is 4 or more longer time means a better outcome
|
up to 48 hours
|
|
total morphine consumption
Time Frame: up to 48 hours
|
intraoperative and post operative higher consumption means a worse outcome
|
up to 48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10/2022ANETH2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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