Using the Adductor Magnus Plain Block As an Innovative Approach for Sciatic Nerve Block for Lower Limb Surgeries.
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.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 22, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedFebruary 28, 2025
February 1, 2025
9 months
February 22, 2025
February 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assessment of sciatic sensory 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.
At 30 minutes after the block
Assessment of sciatic motor block
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
At 30 minutes after the block
Secondary Outcomes (7)
Postoperative pain scores
At 1, 6, 12, and 24 hours post-operative
The onset of sciatic sensory blockades
Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)
The duration of the sciatic nerve block procedure
during sciatic nerve block conduction
Visibility scores for the sciatic nerve
during sciatic nerve block using sub gluteal approach conduction
Visibility scores for Adductor magnus muscle (AMM)
during sciatic nerve block using adductor magnus muscle plain block conduction
- +2 more secondary outcomes
Study Arms (2)
AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks
EXPERIMENTALConduct the sciatic nerve block via adductor magnus plain injection. the femoral nerve block will be conducted as well
SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks
ACTIVE COMPARATORConduct the sciatic nerve block via sub-gluteal approach. the femoral nerve block will be conducted as well
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- ASA (American Society of Anaesthesiologists) Physical Status I-III.
- Patients who consent to receive regional anesthesia.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculity of medicine - Al-Azhar University hospitals
Cairo, Cairo Governorate, 11884, Egypt
Related Publications (3)
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.
PMID: 14980931BACKGROUNDShanthanna 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.
PMID: 25162033BACKGROUNDWang 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.
PMID: 37346396BACKGROUND
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Lecturer of anesthesia, intensive care and pain medicine
Study Record Dates
First Submitted
February 22, 2025
First Posted
February 28, 2025
Study Start
October 1, 2024
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
February 28, 2025
Record last verified: 2025-02