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Postoperative Analgesia After Cesarean Section

Primary Purpose

Postoperative Pain

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Quadratus lumborum block
İlioinguinal-İliohipogastric nerve block
Sponsored by
Gaziosmanpasa Research and Education Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring cesarean section, Quadratus lumborum III block, Ilioinguinal iliohypogastric block, analgesia

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: ASA 1-2, Patients at 37-41 weeks of pregnancy - 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.

Sites / Locations

  • Gaziosmanpasa Research and Education Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Quadratus lumborum block group

İlioinguinal-İliohipogastric nerve block group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2023
Last Updated
August 20, 2023
Sponsor
Gaziosmanpasa Research and Education Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06010602
Brief Title
Postoperative Analgesia After Cesarean Section
Official Title
COMPARISON OF THE POSTOPERATIVE ANALGESIC EFFECTIVENESS OF QUADRATUS LUMBORUM BLOCK (QLB) and ILIOINGUINAL -ILIOHIPOGASTRIC (II-IH) NERVE BLOCK IN CAESER SECTION OPERATIONS
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
We 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. Our 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: To compare the amount of total analgesic use in the first 24 hours in patients 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
cesarean section, Quadratus lumborum III block, Ilioinguinal iliohypogastric block, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Quadratus lumborum block group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
İlioinguinal-İliohipogastric nerve block group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum block
Other Intervention Name(s)
Intravenous analgesic medication
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
İlioinguinal-İliohipogastric nerve block
Other Intervention Name(s)
Intravenous analgesic medication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of first rescue analgesia
Description
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.
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
comparing the amount of total analgesic use in the first 24 hours in patients
Description
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.
Time Frame
24 hours
Title
Comparing the NRS values in 2,4,8,12,24 hours in the postoperative follow-up of the patients
Description
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.
Time Frame
24 hours
Title
Comparing side effects such as postoperative nausea and vomiting
Description
To compare postoperative side effects such as nausea and vomiting within the first 24 hours.
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA 1-2, Patients at 37-41 weeks of pregnancy - 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
serpil sehirlioglu
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa Research and Education Hospital
City
Istanbul
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31523801
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.
Results Reference
result
PubMed Identifier
36626453
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.
Results Reference
result
PubMed Identifier
34117829
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.
Results Reference
result
PubMed Identifier
29377066
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.
Results Reference
result

Learn more about this trial

Postoperative Analgesia After Cesarean Section

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