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| Name | Class |
|---|---|
| Samsun Education and Research Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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". |
|
| 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" |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional Anesthesia Techniques | Other | Fascial Plane Blocks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tramadol Consumption | Tramadol Consumption in 24 hours | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SERKAN TULGAR, M.D. | CLINICAL CHIEF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsun University | Samsun | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2052197 | Background | 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. | |
| 9192462 | Result | Durham SD, Flournoy N, Rosenberger WF. A random walk rule for phase I clinical trials. Biometrics. 1997 Jun;53(2):745-60. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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As suggested by Durham et al and described by Dixon, study randomization will be performed using the biased-coin design up-down sequential method.
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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.
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |