NCT06852118

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

February 22, 2025

Last Update Submit

February 26, 2025

Conditions

Keywords

sciatic nerve blockFemoral nerveAdductor magnus muscleknee surgeries

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

EXPERIMENTAL

Conduct the sciatic nerve block via adductor magnus plain injection. the femoral nerve block will be conducted as well

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

Procedure: SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks

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.

AMM Group: Adductor Magnus Muscle Plane approach + Femoral Nerve Blocks

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

SG Group: Sciatic nerve block by sub-gluteal approach + Femoral nerve blocks

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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: 14980931BACKGROUND
  • 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.

    PMID: 25162033BACKGROUND
  • 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.

    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

Locations