Comparative Analysis of the Impact of Transversus Abdominis Plane Block on Post-Cesarean Pain Management Using Low Concentration Ropivacaine 0,2%
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
地位
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
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Matild Keresztes, Medical doctor
- 电话号码:+40741784066
- 邮箱:keresztesmatild@gmail.com
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
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Mureș County
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Târgu Mureş、Mureș County、罗马尼亚、547581
- 招聘中
- County Emergency Clinical Hospital of Targu Mureș
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接触:
- Matild Keresztes, MD
- 电话号码:0741784066
- 邮箱:keresztesmatild@gmail.com
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接触:
- Janos Szederjesi, MD, PhD Assoc Prof
- 邮箱:yangzi37@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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 |
|---|---|
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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).
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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:
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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.
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"Traditional" analgesia refers to our analgesia technique used in our hospital.
Regular Tramadol, Metamizol, +/- Ibuprofen/Dexketorpofen/Parecoxib
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Postoperative opioid consumption
大体时间:24 hours
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24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recovery after cesarean section using the ObsQoR-11
大体时间:24 hours
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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
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24 hours
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合作者和调查者
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
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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