Analgesic Efficacy of Transvers Abdominis Plane Block and Transversalis Fascia Plane Block in Cesarean Section

NCT06386978 | Completed

• 1 other identifier: 2024/209
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study was designed as a prospective, randomized observational clinical trial. A total of 90 adult women were included in the study performed elective cesarean section. After excluding patients, the care of 90 was included and 3 of these amounts were reserved. TAP Block Group (n=30,Group 1): Spinal Anesthesia + TAP block ; TFP Block group (n=30,Group 2): Spinal Anesthesia + TFP block ; Control group (n=30,Group 3); Spinal Anesthesia + No block;

Conditions

Obstetric

Keywords

ceserean section; transverse abdominis plane block; transversalis facia plane block

Outcome Measures

Primary Outcomes (1)

• VAS score evaluation

  A research asistant, bilinded to the group allocation, interviewedpatients and collected data in the24 hours postoperative period. Verbal Analog Pain Scale Score value will be the lowerst 0 and the highest 10. All the highest value, the patient's pain is at its maximum and whether higher scores mean worse outcome.

  1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period.

Secondary Outcomes (1)

• time until the first analgesic request

  1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period

Other Outcomes (1)

• Satisfaction/Dissatisfaction

  1st, 6th, 12nd, 24 hours at rest, in the first 24hr first day of postoperative period

Study Arms (3)

TAP Group

ACTIVE COMPARATOR

TAP (Transverse Abdominis Plane Block) Block was performed in Group 1 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance.

Procedure: Transverse Facia Plane Block (TAP Block)

TFP Group

ACTIVE COMPARATOR

TFP (Transversalis facia plane block ) Block was performed in Group 2 patients after negative aspiration on both sides, under aseptic conditions with bupivacaine under ultrasonography guidance.

Procedure: Transversalis Facia Plane Block (TFP Block)

Control Group

ACTIVE COMPARATOR

Patients in the Third group will be considered the control group and no block will be performed

Procedure: Control

Interventions

Transverse Facia Plane Block (TAP Block) PROCEDURE

Spinal Anesthesia + TAP block

TAP Group

Transversalis Facia Plane Block (TFP Block) PROCEDURE

Spinal Anesthesia + TFP block

TFP Group

Control PROCEDURE

Spinal anesthesia + No block

Control Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I and ASA II,
• Pregnant patients accepting spinal anesthesia and procedure

You may not qualify if:

• Those who are allergic to local anesthetics,
• Those receiving steroid treatment,
• ASA III, ASA IV and ASA V,
• Patients under the age of 18,
• Patients with preeclampsia,
• Eclampsia,
• Placenta percreta and accreta and its complications,
• Emergency patients.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University

Kayseri, 38039, Turkey (Türkiye)

Location

Related Publications (2)

• Srivastava U, Verma S, Singh TK, Gupta A, Saxsena A, Jagar KD, Gupta M. Efficacy of trans abdominis plane block for post cesarean delivery analgesia: A double-blind, randomized trial. Saudi J Anaesth. 2015 Jul-Sep;9(3):298-302. doi: 10.4103/1658-354X.154732.

  PMID: 26240550 BACKGROUND

• Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.

  PMID: 32412986 BACKGROUND

Study Officials

• Kudret Dogru, Prof.

  TC Erciyes University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 26, 2024
• Study Start: May 30, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 15, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)