Adductor Magnus Plain Injection for Sciatic Nerve BlockNCT06852118
Using the Adductor Magnus Plain Block as an Innovative Approach for Sciatic Nerve Block for Lower Limb Surgeries.
A study testing AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks and SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks in people with Adductor Magnus Plain Injection for Sciatic Nerve Block, run by Mohammed Gaber Saad at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adductor Magnus Plain Injection for Sciatic Nerve Block
- What is being tested?
- AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks and SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anaesthesiologists) Physical Status I-III.
- Patients who consent to receive regional anesthesia.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculity of medicine - Al-Azhar University hospitals
Cairo, Cairo Governorate, 11884
About this study
Official title: 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.
- Being tested
- AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks, SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks
- Keywords
- sciatic nerve block, Femoral nerve, Adductor magnus muscle, knee surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve BlocksProcedure or surgery
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.
SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocksProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks | Experimental | Conduct the sciatic nerve block via adductor magnus plain injection. the femoral nerve block will be conducted as well Receives: Procedure: AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks |
| SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks | Active comparator | Conduct the sciatic nerve block via sub-gluteal approach. the femoral nerve block will be conducted as well Receives: Procedure: SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: At 30 minutes after the block
Secondary outcomes (7)
Postoperative pain scores
Using the Visual Analog Scale (VAS)
Measured: At 1, 6, 12, and 24 hours post-operative
The onset of sciatic sensory blockades
Time in minutes from removing of the local anesthesia needle to the start of sensory changes
Measured: 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
the time in minutes from the start of the sonographic examination for the sciatic nerve block until local anaesthetic administration.
Measured: during sciatic nerve block conduction
Visibility scores for the sciatic nerve
using a 6-point visibility scale: 0: No nerve was identified
- Nerve identified with a high probability
- Nerve identified but most of it was not visible
- Nerve identified and more than 50% of its borders were precisely distinguished from the surrounding structures
- Nerve completely visible but fascicles poorly defined
- Nerve completely visible and multiple fascicles identifiable
Measured: during sciatic nerve block using sub gluteal approach conduction
Visibility scores for Adductor magnus muscle (AMM)
using a 6-point visibility scale for AMM: 0: No muscle was identified
- Muscle identified with a high probability
- Muscle identified but most of it was not visible
- Muscle identified and more than 50% of its epimysium were precisely distinguished from the surrounding structures
- Muscle completely visible but perimysium poorly defined
- Muscle completely visible and multiple perimysium identifiable
Measured: during sciatic nerve block using adductor magnus muscle plain block conduction
Patient satisfaction
Using 4 degrees scale: excellent, good, sufficient, insufficient
Measured: Before the patient discharge
The onset of the Sciatic motor block
Time in minutes from removing of the local anesthesia needle to the start of motor changes
Measured: Every 3 minutes with maximum time 30 minutes (if no changes within 30 min the patient will be excluded from the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adductor Magnus Plain Injection for Sciatic Nerve BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Gaber Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammed Gaber Saad, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852118
- Sponsor's protocol ID
- Anesth-.0435/2024 Med Research
- Status last verified
- Feb 2025
- First submitted
- 22 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 14980931Shanthanna 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.
PubMed 25162033Wang 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.
PubMed 37346396
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06852118
- Acronym / sponsor ID
- Anesth-.0435/2024 Med Research
- Keywords
- sciatic nerve block, Femoral nerve, Adductor magnus muscle, knee surgeries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mohammed Gaber SaadUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks | Experimental | Procedure: AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve BlocksConduct 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 comparator | Procedure: SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocksConduct the sciatic nerve block via sub-gluteal approach. the femoral nerve block will be conducted as well |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anaesthesiologists) Physical Status I-III.
- Patients who consent to receive regional anesthesia.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve BlocksIn 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. | Procedure or surgery | AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks |
| SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocksWhile 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 | Procedure or surgery | SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks |
Primary outcome
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.
Assessment of sciatic motor block
Time frame: At 30 minutes after the 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
7 secondary outcomes
Postoperative pain scores
Time frame: At 1, 6, 12, and 24 hours post-operative
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)
The duration of the sciatic nerve block procedure
Time frame: during sciatic nerve block conduction
Visibility scores for the sciatic nerve
Time frame: during sciatic nerve block using sub gluteal approach conduction
Visibility scores for Adductor magnus muscle (AMM)
Time frame: during sciatic nerve block using adductor magnus muscle plain block conduction
Patient satisfaction
Time frame: Before the patient discharge
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Results publication: PubMed 14980931Ben-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.
- Results publication: PubMed 25162033Shanthanna 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.
- Results publication: PubMed 37346396Wang 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks and SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks in people with Adductor Magnus Plain Injection for Sciatic Nerve Block, run by Mohammed Gaber Saad at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of sciatic sensory block (time frame: At 30 minutes after the block). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06852118, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.