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Clinical Trials/NCT06010602
NCT06010602
Completed
Not Applicable

COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTIVENESS OF QUADRATUS LUMBORUM BLOCK and ILIOINGUINAL -ILIOHIPOGASTRIC NERVE BLOCK IN CESAREAN SECTION OPERATIONS

Gaziosmanpasa Research and Education Hospital1 site in 1 country70 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Gaziosmanpasa Research and Education Hospital
Enrollment
70
Locations
1
Primary Endpoint
Comparison of first rescue analgesia
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
February 15, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Comparison of first rescue analgesia

Time Frame: 24 hour

For all patients, postoperative analgesia was planned as paracetamol 1g four times a day for the first 24 hours after surgery. Patients with Numeric Rating Scale (NRS) scores greater than 3 at 2, 4, 8, 12, and 24 hours postoperatively will receive rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg. The time of the first administration of tramadol hydrochloride for each patient will be compared.

Secondary Outcomes

  • Comparing side effects such as postoperative nausea and vomiting(24 hours)
  • Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients(24 hours)
  • comparing the amount of total analgesic use in the first 24 hours in patients(24 hours)

Study Sites (1)

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