Postoperative Analgesia in Cesarean Delivery

Not Applicable

Completed

• Conditions: Postoperative Pain

• Registration Number: NCT06010602
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

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.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-08-20
• Study First Submitted QC: 2023-08-20
• Study First Posted: 2023-08-24
• Primary Completion: 2023-12-01
• Study Completion: 2024-02-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-30
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of first rescue analgesia	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 Outcome Measures

Name	Time	Method
Comparing side effects such as postoperative nausea and vomiting	24 hours	To compare postoperative side effects such as nausea and vomiting within the first 24 hours.
Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients	24 hours	To compare the Numeric Rating Scale (NRS) values (at rest and with movement) of the patients during postoperative follow-ups at 2, 4, 8, 12, and 24 hours.
comparing the amount of total analgesic use in the first 24 hours in patients	24 hours	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 total tramadol consumption of patients within the first 24 hours will be compared.

Trial Locations

Locations (1)

Gaziosmanpasa Research and Education Hospital; 🇹🇷 Istanbul, Turkey