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临床试验/NCT06858891
NCT06858891尚未招募不适用

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

Adiyaman University Research Hospital0 个研究点目标入组 132 人开始时间: 2025年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
132
主要终点
Perceived Maternal Parenting Self-Efficacy (PMP S-E) score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

Control group

No Intervention

standard pain management

Block group

Experimental

standard pain management + Bilateral TAP block

干预措施: Transversus abdominis plane (TAP) block (Procedure)

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Visual Analog scale (VAS) score(Postoperative 2th, 4th, 6th, 12th and 24th hours)

研究者

发起方
Adiyaman University Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nezir Yılmaz

Associate Professor

Adiyaman University Research Hospital

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