Clinical trial NCT04227912: Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
Official title: Comparison of Postoperative Analgesic Efficacy of Preemptive Ultrasound-guided Transversus Abdominis Plane Block, Ultrasound-guided Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative rescue tramadol consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Analgesic efficacy
timeFrame: 24 hours
measure: Postoperative nausea-vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Di̇yarbakir
country: Turkey
facility: University of Health Sciences Gazi Yaşargil Training and Research Hospital
state: Eyalet/Yerleşke
Study officials:
affiliation: Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
name: Fikret Salık
role: PRINCIPAL_INVESTIGATOR
References:
citation: Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.
citation: Petersen PL, Mathiesen O, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB. The effect of transversus abdominis plane block or local anaesthetic infiltration in inguinal hernia repair: a randomised clinical trial. Eur J Anaesthesiol. 2013 Jul;30(7):415-21. doi: 10.1097/EJA.0b013e32835fc86f.