The Effect of TAP Block on Maternal-Infant Bonding

March 4, 2025 updated by: Nezir Yılmaz, Adiyaman University Research Hospital

The Effect of Transversus Abdominis Plane Block on Maternal-Infant Bonding in Cesarean Sections Performed Under Spinal Anesthesia

Cesarean delivery is a common surgical procedure that is typically performed under spinal anesthesia. Postoperative pain management has a significant impact on both the mother's physical recovery and the quality of maternal-infant bonding. The quality of maternal-infant bonding is influenced by various factors, including postoperative pain, early mobilization, initiation of breastfeeding, stress, psychological status, and hormonal balance. Studies have reported that adequate postoperative pain management, early breastfeeding, and early mobilization have positive effects on maternal-infant bonding.

Transversus abdominis plane (TAP) block is a regional anesthesia technique known for its efficacy in controlling postoperative pain. Bilateral TAP block performed after cesarean section has been associated with lower pain scores, reduced analgesic consumption, and shorter hospital stays. However, its impact on maternal-infant bonding has not been fully elucidated.

This study aims to investigate the effect of bilateral TAP block on maternal-infant bonding in women undergoing cesarean section under spinal anesthesia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study aims to investigate the effect of TAP block on maternal-infant bonding in women undergoing cesarean section under spinal anesthesia. Participants will be randomly assigned to two groups: one group will receive a TAP block in addition to standard care, while the other group will receive only standard pain management. Maternal-infant bonding will be assessed using the maternal bonding scale and behavioral evaluations at 48 hours and one month postpartum.

The primary outcome is to evaluate whether the TAP block improves early bonding by reducing pain and enhancing maternal comfort. Secondary outcomes include maternal pain scores, mobilization time, and initiation of breastfeeding. This study aims to contribute to the optimization of pain management strategies in cesarean deliveries, ultimately improving both maternal recovery and neonatal outcomes.

Study Type

Interventional

Enrollment (Estimated)

132

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 Contact

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
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 aged or older patients,
  • Agree to participate in the study
  • Pregnant women without any maternal or fetal pathology during the pregnancy.

Exclusion Criteria:

  • <18 age
  • Deny to participate in the study
  • maternal or fetal pathology during the pregnancy
  • Allergy to local anesthetics
  • local ingection at block side

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: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
standard pain management
Experimental: Block group
standard pain management + Bilateral TAP block
Procedure: Transversus abdominis plane (TAP) block
Under ultrasound guidance, 20 cc of 0.25% bupivacaine was planned to be administered between the internal oblique and transversus abdominis fascial planes on both lateral aspects of the anterior abdominal wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Maternal Parenting Self-Efficacy (PMP S-E) score
Time Frame: Postoperative 48th hour, based on a single assessment
The PMP S-E is a questionnaire consisting of 18 questions that assess the mother's bond with her baby and her sense of parenthood. Each question consists of 4 options and will be scored on a scale from 0 to 3. The total score of the questionnaire will range from 0 to 54.
Postoperative 48th hour, based on a single assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog scale (VAS) score
Time Frame: Postoperative 2th, 4th, 6th, 12th and 24th hours
Postoperative pain scores will be assesed with visual analog scale at postoperative period. Vas score will range to 0-10. O refers to no pain and 10 refers to the worst pain ever had.
Postoperative 2th, 4th, 6th, 12th and 24th hours

Collaborators and Investigators

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

Sponsor

Adiyaman University Research Hospital

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 (Estimated)

March 10, 2025

Primary Completion (Estimated)

April 5, 2025

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ADYU-NYILMAZ--007

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Cesarean Section

Clinical Trials on Transversus abdominis plane (TAP) block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe