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Not yet recruiting NCT06858891

The Effect of TAP Block on Maternal-Infant Bonding

No phase Interventional Cesarean Section Transversus Abdominis Plane (TAP) Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transversus abdominis plane (TAP) block.
Who it may be relevant to
Registry conditions: Cesarean Section, Transversus Abdominis Plane (TAP) Block. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Perceived Maternal Parenting Self-Efficacy (PMP S-E) score [Time frame: Postoperative 48th hour, based on a single assessment]
Secondary outcome measures (1)
  • Visual Analog scale (VAS) score [Time frame: Postoperative 2th, 4th, 6th, 12th and 24th hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06858891 · ADYU-NYILMAZ--007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗