The Effect of TAP Block on Maternal-Infant Bonding

NCT ID: NCT06858891

Last Updated: 2025-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-04-10

Brief Summary

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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

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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.

Conditions

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Cesarean Section Transversus Abdominis Plane (TAP) Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to two groups using the sealed-envelope method: one group will receive bilateral transversus abdominis plane (TAP) block in addition to standard care, while the other group will receive only standard pain management.
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Investigators
The researchers performing the block procedures were not involved in the postoperative assessment.

Study Groups

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Control group

standard pain management

Group Type NO_INTERVENTION

No interventions assigned to this group

Block group

standard pain management + Bilateral TAP block

Group Type EXPERIMENTAL

Transversus abdominis plane (TAP) block

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Adiyaman University Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nezir Yılmaz

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Nezir Yılmaz, Associate Professor

Role: CONTACT

+905068939496

Other Identifiers

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ADYU-NYILMAZ--007

Identifier Type: -

Identifier Source: org_study_id

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