The Effect of TAP Block on Maternal-Infant Bonding

NCT06858891 | Not Yet Recruiting

• 1 other identifier: ADYU-NYILMAZ--007
• Study Type: interventional
• Target: 132
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cesarean Section; Transversus Abdominis Plane (TAP) Block

Keywords

cesarean section; Transversus Abdominis Plane (TAP) Block; Maternal-Infant Bonding

Outcome Measures

Primary Outcomes (1)

• Perceived Maternal Parenting Self-Efficacy (PMP S-E) score

  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 Outcomes (1)

• Visual Analog scale (VAS) score

  Postoperative 2th, 4th, 6th, 12th and 24th hours

Study Arms (2)

Control group

NO INTERVENTION

standard pain management

Block group

EXPERIMENTAL

standard pain management + Bilateral TAP block

Procedure: Transversus abdominis plane (TAP) block

Interventions

Transversus abdominis plane (TAP) block 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.

Block group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cesarean Section
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Adiyaman University Research Hospital: lead

MeSH Terms

Conditions

Bites and Stings

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Nezir Yılmaz, Associate Professor

CONTACT

+905068939496; yilmaznezir@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researchers performing the block procedures were not involved in the postoperative assessment.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 10, 2025
• Primary Completion: April 5, 2025
• Study Completion: April 10, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02