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Clinical Trials/NCT05758233
NCT05758233
Completed
N/A

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

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 site in 1 country150 target enrollmentJanuary 4, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anesthesia; Sexual
Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Enrollment
150
Locations
1
Primary Endpoint
time of first analgesic need
Status
Completed
Last Updated
2 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
January 4, 2022
End Date
June 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Responsible Party
Principal Investigator
Principal Investigator

Duygu Akyol

Principal Investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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

Outcomes

Primary Outcomes

time of first analgesic need

Time Frame: 24 hours postoperatively

Our primary goal was to meet the initial analgesic requirement times.

Secondary Outcomes

  • visuel analog scale(24 hours postoperatively)

Study Sites (1)

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