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Completed

NCT Number: NCT05408585

MEC90 for Supra-inguinal Fascia Iliaca Block Performed Under Ultrasound Guidance in Arthroscopic Knee Surgery

In this study, the minimum effective concentration required for supra-inguinal fascia iliaca block applied in patients undergoing arthroscopic knee surgery is aimed. The same volume will be used in all of the block applications in the study, and the local anesthetic concentration used will be determined by increasing or decreasing according to the success of the previous block. The primary goal of the study is block success.

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Key information

Conditions

Pain Management Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsun University

Samsun, Turkey (Türkiye)

About this study

For patients included in the study, 40 mL of local anesthetic will be used for SIFIB. The local anesthetic concentration will be randomized using the biased-coin design up-down sequential method, as suggested by Durham et al. and described by Dixon.

The primer outcome of this study is block success. Also, the incidence of motor block formation in the quadriceps muscle (to be defined as paresis or paralysis in knee extension), the amount of tramadol needed in 24 hours, opioid-related side effects (postoperative nausea/vomiting, itching), length of hospital stay and complications that may develop related to the block will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing arthroscopic knee surgery under spinal anesthesia will be included in the study.

Exclusion criteria

  • Conditions where regional anesthesia is contraindicated (coagulopathy, infection..)
  • Patients who underwent general anesthesia for the surgical procedure
  • Patients who do not want to be included in the study by not signing the voluntary consent form.
  • Patients with advanced dementia, orientation-cooperation problems
  • History of allergy to local anesthetic drugs
  • Infection status at the injection site

Treatment and study plan

Regional Anesthesia Techniques

Other

Fascial Plane Blocks

Primary outcomes

  1. Block Success

    Time frame: at 6, 12, 24 hours

    Block success will be evaluated on the post-operative period in the antrior and lateral of thigh using pinprick test.

Secondary outcomes

  1. Tramadol Consumption

    Time frame: 24 hours

    Tramadol Consumption in 24 hours

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Collaborators

  • Samsun Education and Research Hospital

Registry information

Official study title

Minimum Effective Concentration (MEC90) for Supra-inguinal Fascia Iliaca Block Performed Under Ultrasound Guidance in Arthroscopic Knee Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 7, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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