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Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%

2026年5月17日 更新者:Matild Keresztes

The goal of this clinical trial is to evaluate whether the addition of a Transversus Abdominis Plane (TAP) block improves postoperative outcomes in women undergoing cesarean section.

The main questions it aims to answer are:

Does the TAP block reduce postoperative pain scores compared with the traditional analgesic regimen used in our hospital? Does the TAP block decrease opioid consumption within the first 24 hours? Does the TAP block improve the 24-hour quality of recovery? Researchers will compare patients receiving the traditional analgesic regimen with patients who receive the TAP block in addition to standard care to determine differences in pain management, opioid requirements, and recovery quality.

Participants will:

Receive standard anesthetic and perioperative care for cesarean delivery. Be randomized to either the TAP block group or the traditional analgesic regimen group.

Have postoperative pain scores assessed at predefined intervals. Have opioid consumption recorded within the first 24 hours. Complete a quality-of-recovery assessment at 24 hours postoperatively.

研究概览

详细说明

This study will evaluate the effectiveness of a Transversus Abdominis Plane (TAP) block for postoperative analgesia in patients undergoing cesarean section.

Participants randomized to the TAP group will receive an ultrasound-guided TAP block with ropivacaine 0.2% at a dose of 0.4 ml/kg per side. The block will be performed at the end of surgery, under spinal anesthesia, using a linear probe with a lateral approach. After aseptic preparation of the skin, sterile probe covering, and operator sterile technique, the muscle layers will be identified sonographically. A 50 mm or 100 mm needle will be inserted in-plane. Following confirmation of the fascial plane and negative aspiration for blood, local anesthetic will be administered in 5 ml increments, with repeated aspiration to avoid intravascular injection.

Postoperative analgesia in the TAP group will consist of ibuprofen every 8 hours (max 1200mg/day) and paracetamol every 6-8 hours (max 4 gr/day), with tramadol 50 mg available as rescue analgesic.

Participants in the control group (non-TAP) will receive the traditional analgesic regimen used in our hospital: metamizole every 8 hours ( max 3 gr/day), NSAIDs (ibuprofen, dexketoprofen, pareecoxib), paracetamol every 6-8 hours ( max 4 gr/day), and scheduled tramadol, every 8-12 hour ( max 300 mg/day)

Pain assessment and outcomes:

Participants will remain in the obstetric intensive care unit (ICU) for the first 12-24 hours after cesarean delivery, after which they will be transferred to the ward.

Pain will be assessed using the Numeric Rating Scale (NRS) at rest, during mobilization, during breastfeeding, and while standing/walking. The target NRS is ≤4.

Opioid consumption will be recorded during the first 24 hours.

Quality of recovery:

At 24 hours postoperatively, participants will complete the ObsQoR-11 questionnaire, a validated recovery tool consisting of 11 statements.

It comprises 11 items that assess recovery across the key domains of physical comfort, physical independence, psychological well-being, emotional state, and pain control.

Each item is rated by the patient on a 0-10 numerical rating scale, where 0 corresponds to the poorest recovery or complete disagreement with the statement, and 10 corresponds to the best possible recovery or complete agreement with the statement.

The individual item scores are summed to yield a total score ranging from 0 to 110, with higher scores reflecting a better quality of postoperative recovery. The ObsQoR-11 therefore provides a quantitative, standardized, and patient-centered measure of recovery, allowing for both within-group and between-group comparisons in clinical trials.

研究类型

介入性

注册 (估计的)

70

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Janos Szederjesi, MD, PhD Assoc Prof
  • 电话号码:+40745316221
  • 邮箱:yangzi37@gmail.com

学习地点

    • Mureș County
      • Târgu Mureş、Mureș County、罗马尼亚、547581
        • 招聘中
        • County Emergency Clinical Hospital of Targu Mureș
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

pregnant patient anaesthesia type for c-section: spinal

Exclusion Criteria:

general anaesthesia for c-section combined spinal/epidural anaethesia for c-section hipertensive emergencies in obstetrics haemorrhage emergencies in obstetrics

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Postoperative (c-section) TAP block
Post c-section TAP block under spinal anaesthesia. Local anesthetic used in TAP block: Ropivacaine 0,2 %, dose: 0,4 ml/kg per side. Postoperative analgesia regimen: Ibuprofen every 8 hours (total dose 1200 mg/24h) and Paracetamol every 6-8 hours (total dose 4 gr/24 h). Postop analgesia score: numeric rating scale ( 0-10). Rescue analgesia if score is higher then 4: tramadol 50 mg, diluated in 20 ml NaCl 0,9%, administered slow iv ( 5 min).
Postoperative (post cesarean section) TAP block using low concentration Ropivacaine ( 0,2%), volume dose weight calculated: 0,4 ml/kg per side. Total ropivacaine dose 1,6 mg/kg.
其他名称:
  • 分接块
其他:"Traditional" analgesia regimen after c-section
This arm receives the "traditional" analgesia regimen used in our hospital. This analgesia consist of: metamizol 1 gr every 8 hours, paracetamol 1gr every 8 hours, Ibuprofen every 8 hours or dexketoprofen 50 mg every 12 hours or parecoxib 40 mg every 12 hours. The use of NSAID are not mandatory and is doctor dependent. In the traditional analgesia regime we have regular opioids: tramadol 100 mg every 8-12 hours. We assess the pain scores using numeric rating scale (0-10). If pain persist usually rescue analgesia is a second opiod: meperidine 15-20 mg iv.
"Traditional" analgesia refers to our analgesia technique used in our hospital. Regular Tramadol, Metamizol, +/- Ibuprofen/Dexketorpofen/Parecoxib

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Postoperative opioid consumption
大体时间:24 hours
24 hours

次要结果测量

结果测量
措施说明
大体时间
Recovery after cesarean section using the ObsQoR-11
大体时间:24 hours
The ObsQoR-11 is an 11-item, self-report questionnaire used to assess recovery after childbirth, particularly caesarean delivery after 24 hours. It measures four key aspects of recovery: physical comfort, emotional state, physical independence, and the ability to care for the newborn. A higher ObsQoR-11 score indicates better recovery
24 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Janos Szederjesi, MD, PhD Assoc Prof、Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș
  • 首席研究员:Matild Keresztes、Department of Anesthesiology and Intensive Care, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureș

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年3月1日

初级完成 (估计的)

2026年7月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年5月17日

首先提交符合 QC 标准的

2026年5月17日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月17日

最后验证

2025年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 7633/18.04.2024 (其他标识符:Clinical Emergency County Hospital Targu Mures)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 共享支持信息类型

  • 研究方案
  • 树液

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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