Clinical Trials Logo

Clinical Trial Summary

The primary aim of our study was to use spinal anesthesia for unilateral inguinal hernia surgery and lumbar erector spina block supported by local infiltration anesthesia in terms of operation time, intraoperative hemodynamic data, motor block onset time, block termination time, analgesic need, discharge time, patient satisfaction, surgeon satisfaction. is to compare. Its second purpose is to observe nausea, vomiting, urinary retention, headache, chills, bleeding, wound infection.


Clinical Trial Description

Seventy cases of the American Society of Anesthesia physical status (ASA) I-III class between the ages of 18-75 who were hospitalized in the general surgery clinic with the diagnosis of unilateral inguinal hernia will be enrolled in this study prospectively and randomly. The entire work will be conducted in accordance with the principles of the Declaration of Helsinki. The patients will be determined one day in advance with the single-blind method and the closed envelope method, and all patients will be informed about the study plan in detail, and informed patient consent will be obtained. Patients with liver disease, allergy to anesthetic agents, local infection, recurrence, strangulated hernia, patients with a history of allergy to local anesthetics, and patients with a history of anesthesia up to two weeks ago will be excluded from the study. The general surgeon who performs the inguinal hernia repair surgery will not take part in the postoperative follow-up of the patients. Patients with a diagnosis of inguinal hernia who are operated on in our hospital are administered 0.1 mg.kg-midazolam 30 minutes before the block application. Electrocardiogram (ECG), heart rate (HR), peripheral oxygen saturation (SpO2) are monitored in the pre-anesthesia preparation room, and nasal hydration application with 2 l / min O2 and 5 ml kg hr, 0.9% NaCl is started. These patients will be randomly divided into two groups. Patients who underwent spinal anesthesia will be named as Group 1, and patients who underwent Erectile Spina Block and Tumescent anesthesia as Group 2. Group 1 (SE) (n = 35): patients undergoing spinal anesthesia of patients in our hospital to do unilateral inguinal hernia operation, is taken to a seated position on the operating table and a 25 gauge spinal needle under sterile conditions (dominant, Turkey) subarachnoid space entered% in 30 seconds 0, 5 units of levobupivacaine 3 mL is injected. The intervention is started after the patients are placed in the supine position immediately after the spinal block and the level of the sensory block is confirmed by the pin prick test to be at the T10 dermatome. Block application and the times when the sensory block reaches the T10 level are recorded. Surgery is allowed in patients who develop sensory block at the T10 level. During our study, no changes will be made to the procedure described above, which is standardized during our study, only patient data will be recorded observationally. Patients who do not have sufficient sensory block to start the procedure despite waiting 10 minutes will be registered and excluded from the study and additional anesthesia will be applied. Group 2 (Errector spina block + TA) (n = 35): To be used for each patient before the operation to apply tumescent anesthesia-assisted erectile spina block to patients undergoing unilateral inguinal hernia operation in our hospital with erectile spina block + infiltration anesthesia method. A total of 30 ml of mixture is prepared including lidocaine hydrochloride 10mg / ml, adrenaline tartarate (1: 1000) 5 μg / mL, 13 ml in total, 0.5% bupivacaine hydrochloride 13 ml, Sterile Serum 8.4% Sodium Bicarbonate 4 ml. After hemodynamic stability, the patient is placed in the lateral position and infiltration anesthesia with 2% lidocaine is applied. Following aseptic preparation of the skin and probe, a high-frequency linear USG transducer is moved 2.5 cm laterally in the parasagittal plane to visualize the transverse projection of the first lumbar (L1) vertebra. The needle, with real-time imaging of the spreading injected material, TP of L1 and at this level, just below the erector spina muscle, 5 cm, 21G peripheral nerve block needle (Pajuk®, stimuplex HNS12 Germany, Germany) is preferred. During the application, the needle is inserted perpendicular to the skin. Unilateral block is applied at T12 and L1 levels, with 10 ml in each segment. After the needle is withdrawn, pressure is applied to the injection area for 2 minutes and then, the patient is taken to the operation room, the prepared local anesthetic mixture is applied to the patient using the step-by-step technique, 5 ml under the skin and the subcutaneous area around the incision, and the other 5 ml under the fascia, the funiculus (spermatic cord). Tumescent anesthesia is applied around the area and the tissues at the base of the hernia sac. Surgery is permitted in patients who develop sensory block between T10-L1 dermatomes. In our study, patients whose sensory block is controlled by pin-prick test, and patients whose local anesthesia does not create sufficient sensory block to start the skin incision will be excluded from the study and additional anesthesia methods will be applied. The time during which the sensory blocks of the patients disappear will be recorded. During surgery, the sedation level of the patients will be monitored with the Ramsey sedation score (1: agitated, anxiosis, 2: cooperative, 3: response to verbal commands, 4: vivid response to glabella hit or loud stimulus, 5: lazy response to glabella beat or loud stimulus, 6 : no answer). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05073055
Study type Interventional
Source Nigde Omer Halisdemir University
Contact
Status Completed
Phase N/A
Start date January 1, 2021
Completion date December 25, 2022

See also
  Status Clinical Trial Phase
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT03181620 - Sedation Administration Timing: Intermittent Dosing Reduces Time to Extubation N/A
Completed NCT04579354 - Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia N/A
Recruiting NCT06007378 - Optimizing Postoperative Pain Control After Laparoscopic Colorectal Surgery N/A
Recruiting NCT05943015 - Analgesic Efficacy of Quadratus Lumborum, Paravertebral Blocks N/A
Completed NCT04544228 - Ketamine or Neostigmine for Serratus Anterior Plane Block in Modified Radical Mastectomy N/A
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03663478 - Continuous TQL Block for Elective Cesarean Section Phase 4
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Completed NCT05170477 - Influence of Apical Patency Concept Upon Postoperative Pain After Root Canal Treatment N/A
Completed NCT06425601 - A Comparison of Silicone Versus Polyvinylchloride (PVC) Drains Following VATS Lobectomy N/A
Not yet recruiting NCT04561856 - Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone Phase 4
Completed NCT03612947 - TAP Block in Laparoscopic Cholecystectomy. Phase 2
Completed NCT05974501 - Pre vs Post Block in Total Knee Arthroplasty (TKA) Phase 4
Completed NCT05995912 - Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain Phase 2
Completed NCT04571515 - Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain Phase 2
Active, not recruiting NCT04190355 - The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain N/A
Recruiting NCT05145153 - Incidence of Chronic Pain After Thoracic Surgery
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A