Clinical trial NCT05408585: MEC90 for Supra-inguinal Fascia Iliaca Block Performed Under Ultrasound Guidance in Arthroscopic Knee Surgery
Official title: Minimum Effective Concentration (MEC90) for Supra-inguinal Fascia Iliaca Block Performed Under Ultrasound Guidance in Arthroscopic Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Management
Lead sponsor: Samsun University
Sponsor class: OTHER
Collaborators: name: Samsun Education and Research Hospital
First posted: 2022-06-07
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Block Success
timeFrame: at 6, 12, 24 hours
Secondary outcomes:
measure: Tramadol Consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: CLINICAL CHIEF
name: SERKAN TULGAR, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60.