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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-07

Study Completion Date

2023-02-27

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

As suggested by Durham et al and described by Dixon, study randomization will be performed using the biased-coin design up-down sequential method.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

All blocks will be performed by the same experienced anesthetist to ensure block quality and homogeneity. The anesthetist applying the block will not take part in the patient follow-up, the independent assistant following the patient will be blinded to the study.

Study Groups

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SIFIB with concentration "A"

The patients were placed in a supine position, and their skin was disinfected and draped. A linear ultrasonography probe was positioned parasagittally and slightly medially on the anterior superior iliac spine. The sartorius, iliacus, internal oblique muscles and deep circumflex iliac artery were visualized. A 80-mm peripheral nerve block needle was advanced, using the in-plane technique, from cranial to caudal until the tip was positioned between the internal oblique and iliacus muscles. Suprainguinal fascia iliaca block will be performed with concentration "A".

Group Type ACTIVE_COMPARATOR

Regional Anesthesia Techniques

Intervention Type OTHER

Fascial Plane Blocks

SIFIB with concentration "B"

The patients were placed in a supine position, and their skin was disinfected and draped. A linear ultrasonography probe was positioned parasagittally and slightly medially on the anterior superior iliac spine. The sartorius, iliacus, internal oblique muscles and deep circumflex iliac artery were visualized. A 80-mm peripheral nerve block needle was advanced, using the in-plane technique, from cranial to caudal until the tip was positioned between the internal oblique and iliacus muscles.Suprainguinal fascia iliaca block performed with concentration "B"

Group Type ACTIVE_COMPARATOR

Regional Anesthesia Techniques

Intervention Type OTHER

Fascial Plane Blocks

Interventions

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Regional Anesthesia Techniques

Fascial Plane Blocks

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No