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

NCT05408585 | Completed

• 1 other identifier: MEC90
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Block Success

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

  at 6, 12, 24 hours

Secondary Outcomes (1)

• Tramadol Consumption

  24 hours

Study Arms (2)

SIFIB with concentration "A"

ACTIVE COMPARATOR

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".

Other: Regional Anesthesia Techniques

SIFIB with concentration "B"

ACTIVE COMPARATOR

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"

Other: Regional Anesthesia Techniques

Interventions

Regional Anesthesia Techniques OTHER

Fascial Plane Blocks

SIFIB with concentration "A"; SIFIB with concentration "B"

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead
• Samsun Education and Research Hospital: collaborator

Study Sites (1)

Samsun University

Samsun, Turkey (Türkiye)

Location

Related Publications (2)

• Dixon WJ. Staircase bioassay: the up-and-down method. Neurosci Biobehav Rev. 1991 Spring;15(1):47-50. doi: 10.1016/s0149-7634(05)80090-9.

  PMID: 2052197 BACKGROUND

• Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.

  PMID: 9192462 RESULT

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• SERKAN TULGAR, M.D.

  CLINICAL CHIEF

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 7, 2022
• Study Start: June 7, 2022
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)