Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block

Study Overview
=================
Brief Summary
-----------------
The subject of the study is to compare the analgesic efficacy of transversalis fascia plan block and erector spina plane block applied with ultrasonography in patients who have undergone inguinal hernia operation. The aim of the study is to compare two different regional anesthesia methods applied in the postoperative period in terms of 24-hour opioid consumption, pain scores, additional analgesic need, and side effects and complications in the postoperative period.

Detailed Description
-----------------
An identification number (ID) number will be randomly assigned to each patient, whose written consent was obtained before the surgery, when they are admitted to the postoperative recovery room. In the postoperative period, patients will be followed up with these numbers in patient follow-up. Which group the patients will be included in will be determined by the closed envelope method. The anesthetist, who will perform the regional block, will give the block to be applied in a sealed envelope by an assistant staff outside the study, and at the same time, the patient will not know which block has been made. The anesthesiologist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another investigator blinded to the study. Spinal anesthesia will be applied to all patients and inguinal hernia operation will be appropriate. Patients taken to the recovery room will be divided into two groups. Transversalis fascia plan block (Group T) will be applied to the patients in a group after local cleansing of the skin area, accompanied by ultrasonography. The patients in the other group will be treated with an erector spina plane block (Group E) following local cleansing of the skin area, accompanied by ultrasonography. In both block management, 0.25% bupivacaine (Buvasin Vem İlaç, Turkey) (15 ml physiological saline + 15 ml 0.5% bupivacaine) total amount of 30 ml, same volume and same concentration will be used. After the block procedure, the patient will be observed in the recovery room for side effects. Patient-controlled analgesia (PCA) will be used as a standard in the treatment of postoperative pain in patients in both groups without any complications. Tramadol HCL, which is routinely used for postoperative pain control for PCA, will be used (3 mg/ml, total volume 100 mL). Evaluation of postoperative pain will be done with numerical rating scale (NRS).Pain levels will be questioned in two different ways as rest and cough.

Official Title
-----------------
Comparison of Postoperative Analgesic Efficacy of Transversalis Fascia Plan Block and Erector Spina Plan Block

Conditions
-----------------
Regional Anesthesia

Intervention / Treatment
-----------------
* Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those who underwent unilateral inguinal hernia surgery under elective conditions 18-65 years ASA I-III Patients with written consent who agreed to participate in the study Exclusion Criteria: Body mass index > 35 kg/m², Coagulopathy and local infection or hematoma in the area to be blocked, Allergic to a local anesthetic agent or one of the drugs used in the study, Those with a history of chronic opioid and corticosteroid use, Unable to use the patient-controlled analgesia system, Those with psychiatric illness, Cases with a surgical time of less than 30 minutes and more than 120 minutes for better standardization of studies, Patients who do not agree to participate in the study will not be included in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transversalis fascia plan block (Group T)<br>After local cleaning of the skin area, the transducer will be placed on the iliac crest in the transverse plane with a low-frequency convex probe, and the skin, subcutaneous tissue, external oblique muscle will be placed with a 20 G, 100 mm needle. After visualization of the internal oblique muscle and transversus abdominis muscles and finally the deep fascia of the transversus abdominis, local anesthetic will be given unilaterally between the last part of the transversus abdominis muscle and the transversalis fascia with the out-off plan technique. | Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)<br>* A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in both groups.<br>|
| Active Comparator: Erector spina plan block (Group E)<br>After local cleaning of the skin area, a convex probe is determined to be placed longitudinally 3 cm lateral to the spinous process of the T11 vertebra, after determining the erector spina muscle, with a 20 G, 100 mm needle inplane method in the craniocaudal direction will be advanced and a local anesthetic will be administered between the erector spinae muscle and the transverse process. | Device: Low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy)<br>* A low frequency convex probe (ESAOTE Fixed Color Doppler Ultrasonography Device, Italy) device will be used while blocking in both groups.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid use | To determine the amount of analgesic consumption in the postoperative first 24 hours with PCA in the postoperative period. | Postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale | To determine the pain of the patients at rest and coughing at the 1st, 3rd, 6th, 12th, 18th and 24th hours postoperatively with Numerical Rating Scale (NRS).The NRS is a segmented numerical version in which the respondent selects an integer (0-10) that best reflects the intensity of their pain. 0: no pain 1-3: mild pain 4-6: moderate pain 7-10: severe pain. | Postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
regional analgesia, transversalis fascia plane block, erector spina plane block