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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05408585
• Other study ID #: MEC90
• Status: Completed
• Phase: N/A
• Start date: June 7, 2022
• Est. completion date: February 27, 2023

Study information

• Verified date: February 2023
• Source: Samsun University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Management

Intervention

Other:
• Regional Anesthesia Techniques
Fascial Plane Blocks

Locations

Country	Name	City	State
Turkey	Samsun University	Samsun

Sponsors (2)

Lead Sponsor	Collaborator
Samsun University	Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Tramadol Consumption	Tramadol Consumption in 24 hours	24 hours