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The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section

Primary Purpose

Anesthesia; Sexual, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Patients undergoing transversalis fascia plane block
Patients undergoing transversus abdominis plane block
Sponsored by
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia; Sexual focused on measuring anesthesia recovery period, cesarean section, obstetric anesthesia, spinal anaesthesia, postoperative analgesia

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 20-50 years old pregnant woman ASAII-III Patients accepting spinal anesthesia Exclusion Criteria: Morbid obesity(BMI >40) Patients who are switched to general anesthesia in an unexpected perioperative situation Patients with placental anomaly Patients with bupivacaine allergy Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia

Sites / Locations

  • Başakşehir Çam and Sakura City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Grup 1: Transversalis Fascia Plane Block (TFPB)

Grup 2: Transversus Abdominis Plane Block (TAPB)

Arm Description

Transversalis Fascia Plane Block (TFPB)

Transversus Abdominis Plane Block (TAPB)

Outcomes

Primary Outcome Measures

time of first analgesic need
Our primary goal was to meet the initial analgesic requirement times.

Secondary Outcome Measures

visuel analog scale
Our secondary aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Visual analog scale(VAS) was used to assess postoperative pain.6th, 12th, 24th hour VAS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.

Full Information

First Posted
February 20, 2023
Last Updated
July 13, 2023
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05758233
Brief Title
The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section
Official Title
Comparison of the Effectiveness of Ultrasound-guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Pain in Caesarean Section : a Prospective Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training 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
The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia. The main question[s] it aims to answer are: [Is transversalis fascia plane block more effective in postoperative analgesia? ] [Is there a difference between the duration of postoperative first analgesia requirement? ] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.
Detailed Description
This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A total of 150 patients were divided into two groups: transversal fascia plane block (TFPB group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic requirement, analgesic requirements, nausea & vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia; Sexual, Analgesia
Keywords
anesthesia recovery period, cesarean section, obstetric anesthesia, spinal anaesthesia, postoperative analgesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomize study
Masking
None (Open Label)
Masking Description
prospective randomize study
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Grup 1: Transversalis Fascia Plane Block (TFPB)
Arm Type
Experimental
Arm Description
Transversalis Fascia Plane Block (TFPB)
Arm Title
Grup 2: Transversus Abdominis Plane Block (TAPB)
Arm Type
Experimental
Arm Description
Transversus Abdominis Plane Block (TAPB)
Intervention Type
Procedure
Intervention Name(s)
Patients undergoing transversalis fascia plane block
Intervention Description
The investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.
Intervention Type
Procedure
Intervention Name(s)
Patients undergoing transversus abdominis plane block
Intervention Description
The investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.
Primary Outcome Measure Information:
Title
time of first analgesic need
Description
Our primary goal was to meet the initial analgesic requirement times.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
visuel analog scale
Description
Our secondary aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Visual analog scale(VAS) was used to assess postoperative pain.6th, 12th, 24th hour VAS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
20-50 age
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 20-50 years old pregnant woman ASAII-III Patients accepting spinal anesthesia Exclusion Criteria: Morbid obesity(BMI >40) Patients who are switched to general anesthesia in an unexpected perioperative situation Patients with placental anomaly Patients with bupivacaine allergy Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duygu Akyol, M.D
Organizational Affiliation
Basaksehir Cam & Sakura Şehir Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Başakşehir Çam and Sakura City Hospital
City
Istanbul
State/Province
Basaksehir
ZIP/Postal Code
3268
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35455750
Citation
Ryu C, Choi GJ, Jung YH, Baek CW, Cho CK, Kang H. Postoperative Analgesic Effectiveness of Peripheral Nerve Blocks in Cesarean Delivery: A Systematic Review and Network Meta-Analysis. J Pers Med. 2022 Apr 14;12(4):634. doi: 10.3390/jpm12040634.
Results Reference
background
PubMed Identifier
31653797
Citation
Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print.
Results Reference
result

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The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section

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