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

Not Applicable

Completed

• Conditions: Analgesia; Anesthesia; Sexual
• Interventions: Procedure: Patients undergoing transversalis fascia plane block; Procedure: Patients undergoing transversus abdominis plane block

• Registration Number: NCT05758233
• Lead Sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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 .

Study Timeline

• Study Start: 2022-01-04
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-24
• Study First Posted: 2023-03-07
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup 1: Transversalis Fascia Plane Block (TFPB)	Patients undergoing transversus abdominis plane block	Transversalis Fascia Plane Block (TFPB)
Grup 2: Transversus Abdominis Plane Block (TAPB)	Patients undergoing transversalis fascia plane block	Transversus Abdominis Plane Block (TAPB)
Grup 2: Transversus Abdominis Plane Block (TAPB)	Patients undergoing transversus abdominis plane block	Transversus Abdominis Plane Block (TAPB)
Grup 1: Transversalis Fascia Plane Block (TFPB)	Patients undergoing transversalis fascia plane block	Transversalis Fascia Plane Block (TFPB)

Primary Outcome Measures

Name	Time	Method
time of first analgesic need	24 hours postoperatively	Our primary goal was to meet the initial analgesic requirement times.

Secondary Outcome Measures

Name	Time	Method
visuel analog scale	24 hours postoperatively	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.

Trial Locations

Locations (1)

Başakşehir Çam and Sakura City Hospital; 🇹🇷 Istanbul, Basaksehir, Turkey