Postoperative Analgesia in Cesarean Delivery

NCT06010602 | Completed

• 1 other identifier: GaziosmanpasaTREH47
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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. 1.To compare the amount of total analgesic use in the first 24 hours in patients
2. 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. 3.Comparing the side effects such as postoperative nausea and vomiting

Conditions

Postoperative Pain

Keywords

cesarean section; Quadratus lumborum III block; Ilioinguinal iliohypogastric block; analgesia

Outcome Measures

Primary Outcomes (1)

• Comparison of first rescue analgesia

  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.

  24 hour

Secondary Outcomes (3)

• comparing the amount of total analgesic use in the first 24 hours in patients

  24 hours

• Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients

  24 hours

• Comparing side effects such as postoperative nausea and vomiting

  24 hours

Study Arms (2)

Quadratus lumborum block group

ACTIVE COMPARATOR

the patient In the lateral decubitus position, a subcostal area and above the iliac crest in the mid-axillary line, a convex ultrasound probe is placed under sterile conditions. Using an in-plane technique, the quadratus lumborum and psoas major muscles, as well as the transverse process of the L4 vertebra, are visualized. 22G, 100 mm peripheral block needle is used to perform the block. The needle is directed between the quadratus lumborum muscle and the psoas major muscle in the subfascial plane, following hydrodissection for proper needle placement. Then, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc to ensure proper spread. The injection is performed under ultrasound guidance, visualizing the local anesthetic pushing the fascia. The same procedure will be repeated for the other side.

Procedure: Quadratus lumborum block

İlioinguinal-İliohipogastric nerve block group

ACTIVE COMPARATOR

the patient in the supine position, a linear ultrasound probe is placed over the spina iliaca anterior superior (SIAS) line, drawn from SIAS to the umbilicus. The probe is used to visualize the abdominal wall muscles, focusing on the fascial plane between the transversus abdominis and internal oblique muscles, where a flattened football-like appearance is seen. The iliohypogastric nerve is observed more laterally, and the ilioinguinal nerve is seen more medially. Using an in-plane technique with 22G, 100 mm peripheral block needle, local anesthetic is injected near the SIAS, between the transversus abdominis and internal oblique muscles. Again, 20 mL of 0.25% bupivacaine is injected slowly, aspirating every 5 cc, and the injection is visualized under ultrasound guidance, ensuring proper fascial spread. The same procedure will be repeated for the other side.

Procedure: İlioinguinal-İliohipogastric nerve block

Interventions

Quadratus lumborum block PROCEDURE

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 were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.

Also known as: Intravenous analgesic medication

Quadratus lumborum block group

İlioinguinal-İliohipogastric nerve block PROCEDURE

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 were administered rescue analgesia with tramadol hydrochloride at a dose of 1mg/kg.

Also known as: Intravenous analgesic medication

İlioinguinal-İliohipogastric nerve block group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31523801 RESULT

• 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.

  PMID: 36626453 RESULT

• 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.

  PMID: 34117829 RESULT

• 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.

  PMID: 29377066 RESULT

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• serpil sehirlioglu

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2023
• First Posted: August 24, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: January 1, 2024
• Last Updated: September 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)