Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section (TAPTFPB)

April 24, 2025 updated by: Ali Ahiskalioglu, Ataturk University

Combined Transversalis Fascia and Transversus Abdominis Plane Blocks Versus Intrathecal Morphine: Effects on Postoperative Opioid Consumption and Obstetric Recovery After Cesarean Section

Cesarean delivery rates are rising globally, and effective postoperative analgesia is crucial for maternal recovery and newborn care. While intrathecal morphine offers strong analgesia, it may cause side effects such as nausea, pruritus, or respiratory depression. The transversus abdominis plane (TAP) block provides somatic pain relief but is often insufficient alone. The transversalis fascia plane block (TFPB) has been shown to enhance lower abdominal analgesia. This study aims to evaluate whether combining TAP and TFP blocks can provide analgesic efficacy comparable to intrathecal morphine in cesarean section patients who are unable to receive opioids or are at high risk of side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25100
        • Ataturk University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18-45 years old
  • American Society of Anesthesiologists physical score I or II
  • caesarean section with a Pfannenstiel incision

Exclusion Criteria:

  • additional surgical intervention, or received general anaesthesia,
  • hypersensitivity to the agents to be used
  • BMI greater than 35 kg m-2
  • coagulopathy,
  • local infection,
  • opioid addiction,
  • pregnancy-related hypertension
  • diabetes mellitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intrathecal Morphine
Procedure: Intrathecal Morphine
100 mcg morphine with local anesthetics injected intrathecally
Active Comparator: Transversalis fascia+Transversus abominis plane block
Procedure: Transversalis fascia plane block and transversus abdominis plane block
20 ml local anesthetics for Transversus Abdominis Plane block and 10 ml local anesthetics for Trasnversalis fascia plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Obstetric Quality of Recovery-10 (ObsQoR-10) Score
Time Frame: Postoperative 24 hours
The questionnaire's subscales are physical comfort (n=3 items), emotional state (n=2 items), pain (n=1 item), physical independence (n=2 items), and the ability to take care of the newborn (n=2 items). Each item is scored on a scale of 0-10, except for the first four items, which are graduated from 10 to 0. The total score is the sum of all item scores (i.e. a score ranging from 0 to 100, where 0 is the worst recovery score, and 100 indicates the best).
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption
Time Frame: Postoperative 24. hours
Patient controlled analgesia based opioid requirement
Postoperative 24. hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Investigators

  • Principal Investigator: Ali Ahiskalioglu, Prof., Atatürk University, Faculty of Medicine, Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

March 1, 2025

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUTFTAPTFP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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