- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06852118
Using the Adductor Magnus Plain Block As an Innovative Approach for Sciatic Nerve Block for Lower Limb Surgeries.
February 26, 2025 updated by: Mohammed Gaber Saad
Efficacy of Adductor Magnus Muscle Plane Injection for Sciatic Nerve Block Versus Subgluteal Approach in Combination with Femoral Nerve Block in Knee Surgeries- a Randomized Control Study.
the goal of this clinical trial is to compare the efficacy of adductor magnus muscle plane injection as an approach for sciatic nerve block to sub-gluteal approach in combination with femoral nerve blocks as perioperative analgesia in knee surgeries.
Study Overview
Status
Active, not recruiting
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cairo, Egypt, 11884
- Faculity of medicine - Al-Azhar University hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- ASA (American Society of Anaesthesiologists) Physical Status I-III.
- Patients who consent to receive regional anesthesia.
Exclusion Criteria:
- Patients with a history of allergy to local anesthetics.
- Pre-existing neurological deficits in the lower extremities.
- Coagulopathy or anticoagulation therapy that cannot be safely discontinued.
- Infection at the site of block injection.
- Severe obesity (BMI > 40).
- Patients with contraindications to regional anesthesia.
- peripheral neuropathy.
- Psychiatric disorders and communication difficulties.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks
Conduct the sciatic nerve block via adductor magnus plain injection.
the femoral nerve block will be conducted as well
|
In the supine position, the femoral nerve block will be conducted using a high-frequency ultrasound probe to identify the femoral nerve just below the fascia iliaca.
After proper sterilization, the needle will be advanced in-plane to inject 15 ml bupivacaine 0.5% around the nerve.
After performing the femoral nerve block, the adductor magnus muscle plane block will be performed using a low-frequency ultrasound probe positioned 6 cm distal to the inguinal crease to identify the sartorius muscle, femoral artery, femoral vein, and femoral nerve on the deep side of the sartorius muscle, the probe will be slide by about 2-2.5 cm distally, where we could identify the plane between the adductor magnus and the semimembranosus muscles, and after proper sterilization, the needle will be slowly advanced until the needle tip is close to the posterior surface of the AMM, 20 mL of bupivacaine 0.5% will be injected while observing fluid distribution under the posterior surface of the AMM, Then GA.
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Active Comparator: SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks
Conduct the sciatic nerve block via sub-gluteal approach.
the femoral nerve block will be conducted as well
|
While the patient is in the supine position, the femoral nerve block will be conducted using a high-frequency ultrasound probe to identify a cross-sectional view of the femoral nerve just below the fascia iliaca.
After proper sterilization, the needle will be advanced in-plane to inject 15 ml bupivacaine 0.5% around the nerve.
the patient will be turned on their sides with the operative side uppermost and flexed, the sub-gluteal sciatic nerve will be identified using a low-frequency probe, and then the same needle will be advanced the in-plane to inject 20 ml bupivacaine 0.5% around the nerve., then GA will be conducted as the other group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of sciatic sensory block
Time Frame: At 30 minutes after the block
|
It will be assessed by evaluating the sharp sensation with pinprick testing, and the presence or loss of cold-warm feeling as (2 for normal sensory perception, 1 for loss of cold-warm feeling, and 0 for loss of pinprick sensation) for ciatic in the sole of foot.
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At 30 minutes after the block
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Assessment of sciatic motor block
Time Frame: At 30 minutes after the block
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Sciatic block will be evaluated by the motion of the foot and ankle joint (3 for normal movement, 2 for unable to push or flex the foot against external resistance, 1 for unable to push or flex the foot against gravity and 0 for no motion
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At 30 minutes after the block
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain scores
Time Frame: At 1, 6, 12, and 24 hours post-operative
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Using the Visual Analog Scale (VAS)
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At 1, 6, 12, and 24 hours post-operative
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The onset of sciatic sensory blockades
Time Frame: Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)
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Time in minutes from removing of the local anesthesia needle to the start of sensory changes
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Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)
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The duration of the sciatic nerve block procedure
Time Frame: during sciatic nerve block conduction
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the time in minutes from the start of the sonographic examination for the sciatic nerve block until local anaesthetic administration.
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during sciatic nerve block conduction
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Visibility scores for the sciatic nerve
Time Frame: during sciatic nerve block using sub gluteal approach conduction
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using a 6-point visibility scale: 0: No nerve was identified
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during sciatic nerve block using sub gluteal approach conduction
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Visibility scores for Adductor magnus muscle (AMM)
Time Frame: during sciatic nerve block using adductor magnus muscle plain block conduction
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using a 6-point visibility scale for AMM: 0: No muscle was identified
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during sciatic nerve block using adductor magnus muscle plain block conduction
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Patient satisfaction
Time Frame: Before the patient discharge
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Using 4 degrees scale: excellent, good, sufficient, insufficient
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Before the patient discharge
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The onset of the Sciatic motor block
Time Frame: Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)
|
Time in minutes from removing of the local anesthesia needle to the start of motor changes
|
Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Shanthanna H, Singh B, Guyatt G. A systematic review and meta-analysis of caudal block as compared to noncaudal regional techniques for inguinal surgeries in children. Biomed Res Int. 2014;2014:890626. doi: 10.1155/2014/890626. Epub 2014 Aug 5.
- Ben-David B, Schmalenberger K, Chelly JE. Analgesia after total knee arthroplasty: is continuous sciatic blockade needed in addition to continuous femoral blockade? Anesth Analg. 2004 Mar;98(3):747-9, table of contents. doi: 10.1213/01.ane.0000096186.89230.56.
- Wang L, Qu Y, Deng Y, Li J, Liu Y, Wu C. Evaluation of a New Method of Sciatic Nerve Block: A Prospective Pilot Study. J Pain Res. 2023 Jun 16;16:2091-2099. doi: 10.2147/JPR.S404489. eCollection 2023.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 2025
Study Registration Dates
First Submitted
February 22, 2025
First Submitted That Met QC Criteria
February 26, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 26, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Anesth-.0435/2024 Med Research
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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