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Clinical Trials/NCT05758233
NCT05758233CompletedNot Applicable

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 Hospital2 sites in 1 country150 target enrollmentStarted: January 4, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
150
Locations
2
Primary Endpoint
time of first analgesic need

Study 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 .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Masking Description

prospective randomize study

Eligibility Criteria

Ages
20 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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)

Investigators

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

Duygu Akyol

Principal Investigator

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Study Sites (2)

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