Clinical trial NCT06010602: Postoperative Analgesia in Cesarean Delivery
Official title: COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTIVENESS OF QUADRATUS LUMBORUM BLOCK and ILIOINGUINAL -ILIOHIPOGASTRIC NERVE BLOCK IN CESAREAN SECTION OPERATIONS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: cesarean section
Quadratus lumborum III block
Ilioinguinal iliohypogastric block
analgesia
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: İn this study, planned to compare the post-operative analgesic efficacy of Ilioinguinal iliohypogastric (II-IH) nerve block and Quadratus lumborum III Block in elective cesarean section operations.

this study primary aim is; To compare and evaluate the first rescue analgesia requirement times after Quadratus lumborum III and II-IH Block for postoperative analgesia after elective cesarean section operations under spinal anesthesia.

Our secondary aims are:

1. To compare the amount of total analgesic use in the first 24 hours in patients
2. To compare the NRS (Numering rating scale) values (resting and dynamic) at 2. 4. 8. 12 . 24. hours in the postoperative follow-up of the patients
3. Comparing the side effects such as postoperative nausea and vomiting

Detailed description: Patients who underwent elective cesarean section under spinal anesthesia will be divided into two groups at the end of the operation, using the closed envelope randomization method as Quadratus lumborum III and II-IH nerve block. Spinal anesthesia will be applied to all patients who will undergo elective cesarean section. At the end of the operation, they will be taken to the postoperative block room. All blocks will be performed by the same anesthesiologist under USG guidance. 20 ml of 0.25% bupivacaine will be used in the blocks. All patients will be followed in the block room for 30 minutes after the block application. Patients with a Modified Aldret score above 8 will be sent to the service because they are under spinal anesthesia at the end of the operation.At the end of the operation, when the spinal level regresses to two dermatome levels, paracetamol 1gr IV will be administered to all patients for post-op analgesia.Postoperative analgesia was planned for the patients as paracetamol 4x1 gr. Tramadol hydrochloride 1mg/kg was planned as rescue analgesia in the ward for patients with NRS scores greater than 3 in their postoperative follow-up.

Patients 2.,4.,8.,12.,24. hours will be followed by an anesthesia assistant who is different from the researcher who applied the block and who is blind for the study. The patients' first rescue analgesia times, NRS scores, postoperative side effects, and total analgesic amounts used in 24 hours will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 40
* ASA 2 risk group
* Patients at 37-41 weeks of pregnancy
* undergoing cesarean section under spinal anesthesia

Exclusion Criteria:

* The patient does not accept the procedure.
* Patients with a history of eclampsia and preeclampsia during pregnancy
* local anesthetic allergy
* Infection at the procedure site
* Anticoagulant use with bleeding disorder
* Chronic analgesia and opioid use
* Mental, psychiatric and neurological problems
* Patients with ASA 3 and above with a history of any chronic disease.

Primary outcomes:
measure: Comparison of first rescue analgesia
timeFrame: 24 hour
Secondary outcomes:
measure: comparing the amount of total analgesic use in the first 24 hours in patients
timeFrame: 24 hours
measure: Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients
timeFrame: 24 hours
measure: Comparing side effects such as postoperative nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Research and Education Hospital
Study officials:
affiliation: Gaziosmanpasa Research and Education Hospital
name: serpil sehirlioglu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Irwin R, Stanescu S, Buzaianu C, Rademan M, Roddy J, Gormley C, Tan T. Quadratus lumborum block for analgesia after caesarean section: a randomised controlled trial. Anaesthesia. 2020 Jan;75(1):89-95. doi: 10.1111/anae.14852. Epub 2019 Sep 15.
citation: Yetik F, Yilmaz C, Karasu D, Haliloglu Dastan N, Dayioglu M, Baytar C. Comparison of ultrasound-guided quadratus lumborum block-2 and quadratus lumborum block-3 for postoperative pain in cesarean section: A randomized clinical trial. Medicine (Baltimore). 2022 Dec 9;101(49):e31844. doi: 10.1097/MD.0000000000031844.
citation: Koksal E, Aygun H, Genc C, Kaya C, Dost B. Comparison of the analgesic effects of two quadratus lumborum blocks (QLBs), QLB type II vs QLB type III, in caesarean delivery: A randomised study. Int J Clin Pract. 2021 Oct;75(10):e14513. doi: 10.1111/ijcp.14513. Epub 2021 Jun 23.
citation: Staker JJ, Liu D, Church R, Carlson DJ, Panahkhahi M, Lim A, LeCong T. A triple-blind, placebo-controlled randomised trial of the ilioinguinal-transversus abdominis plane (I-TAP) nerve block for elective caesarean section. Anaesthesia. 2018 May;73(5):594-602. doi: 10.1111/anae.14222. Epub 2018 Jan 29.