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

Sponsor
Samsun University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05408585
Collaborator
Samsun Education and Research Hospital (Other)
50
Enrollment
1
Location
2
Arms
3.1
Anticipated Duration (Months)
16
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Regional Anesthesia Techniques
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
As suggested by Durham et al and described by Dixon, study randomization will be performed using the biased-coin design up-down sequential method.As suggested by Durham et al and described by Dixon, study randomization will be performed using the biased-coin design up-down sequential method.
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Supportive Care
Official Title:
Minimum Effective Concentration (MEC90) for Supra-inguinal Fascia Iliaca Block Performed Under Ultrasound Guidance in Arthroscopic Knee Surgery
Actual Study Start Date :
Jun 7, 2022
Anticipated Primary Completion Date :
Aug 10, 2022
Anticipated Study Completion Date :
Sep 10, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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".

Other: Regional Anesthesia Techniques
Fascial Plane Blocks
Active Comparator: 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"

Other: Regional Anesthesia Techniques
Fascial Plane Blocks

Outcome Measures

Primary Outcome Measures

  1. Block Success [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 Outcome Measures

  1. Tramadol Consumption [24 hours]

    Tramadol Consumption in 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsun University Samsun Turkey

Sponsors and Collaborators

  • Samsun University
  • Samsun Education and Research Hospital

Investigators

  • Study Director: SERKAN TULGAR, M.D., CLINICAL CHIEF

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Samsun University
ClinicalTrials.gov Identifier:
NCT05408585
Other Study ID Numbers:
  • MEC90
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Anesthetics

Study Results

No Results Posted as of Jun 8, 2022