Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Other: Transversus abdominis plane block; Other: Local anesthetic infiltration; Other: Intravenous dexketoprofen

• Registration Number: NCT04227912
• Lead Sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Brief Summary

This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs.

Detailed Description

Currently, multimodal techniques are used in inguinal hernia repairs in addition to pharmacological and regional techniques for postoperative analgesia.TAP block is performed on the principle of hydrodissection of the fascia between the internal oblique and transversus abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic drug is also used as pharmacological postoperative analgesia method in most clinics.

Study Timeline

• Study Start: 2019-02-11
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Study First Posted: 2020-01-14
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subject who aged 18-75 years
• American Society of Anesthesiologist (ASA) I-III
• Subject undergoing unilateral or bilateral inguinal hernia repair

Exclusion Criteria

• Subject under 18 and over 75 years of age
• ASA IV
• History of allergy to agents
• Analgesic drug use in the last 48 hours
• Morbid obese (BMI> 35)
• Confusion
• Coagulopathy
• Local infection at the injection site
• Subject with heart, lung, hematologic, metabolic and endocrine disease
• Subject who did not want to be included in the study
• Subject who refused the spinal anesthesia
• Subject who failed the spinal anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TAP	Transversus abdominis plane block	Ultrasound-guided TAP Block
Group Local	Local anesthetic infiltration	Ultrasound-guided Local Infiltration
Group Dexketoprofen	Intravenous dexketoprofen	Intravenous Dexketoprofen

Primary Outcome Measures

Name	Time	Method
Postoperative rescue tramadol consumption	24 hours	The mean tramadol consumption in the first 24 post-operative hours

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea-vomiting	24 hours	Postoperative nausea-vomiting was evaluated with a 3-point system (0: no nausea and vomiting, 1: nausea, but no vomiting, 2: nausea with or without nausea) 24 hours postoperatively.
Analgesic efficacy	24 hours	Postoperative visual analog scale score recorded 0-10 (0 = no pain, 10 = severe pain) at 30. min, 1, 2, 4, 8, 12, 16 and 24 hours postoperatively

Trial Locations

Locations (1)

University of Health Sciences Gazi Yaşargil Training and Research Hospital; 🇹🇷 Di̇yarbakir, Eyalet/Yerleşke, Turkey