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临床试验/NCT02893423
NCT02893423终止不适用

The Dose Dependent Effect of Ropivacaine Transversus Abdominis Plane Blocks on Postoperative Analgesia After Cesarean Section

Maimonides Medical Center1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
51
试验地点
1
主要终点
POSTOPERATIVE PAIN

研究概览

简要总结

With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section).

详细描述

With this research the investigators hope to determine the lowest dose of ropivacaine used in transversus abdominis plane (TAP) blocks that can effectively treat pain in women after cesarean section (c-section). The TAP is a space between the muscle layers of the abdominal wall that houses nerves supplying the abdominal skin. The investigators will inject the local anesthetic ropivacaine into this space to freeze these nerves and prevent pain following c-section. The investigators will compare three different doses of ropivacaine (0.5%, 0.25%, 0%) to determine the lowest dose that controls pain with the fewest side effects. Participants in this study will receive 0.5% (Group 1), 0.25% (Group 2), or 0% (Group 3) ropivacaine TAP blocks to control pain after c-section. At 2, 6, 12, 24, and 48 hours after cesarean section visual analog pain scores (VAS) for pain on movement, pain at rest, and pain with cough will be collected along with the time to first postoperative analgesic request, patient satisfaction scores, and patient demographics. The analgesic regimen will be considered effective if it provides lower average visual analog scores for pain with movement. Secondary outcomes will be higher patient satisfaction, better pain control, fewer postoperative analgesic requests, and fewer side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Pregnant patients undergoing elective c-section
  • Exclusion criteria:
  • Allergy to local anesthetics
  • Contraindication to tap blocks

排除标准

  • 未提供

研究组 & 干预措施

Group 1 - 0.5% Ropivacaine

Active Comparator

Patients will receive 0.5% Ropivacaine for the TAP block Procedure: Ultrasound guided TAP BLOCK Drug: 0.5% ropivacaine 20ml of 0.5% ropivacaine is used to perform the TAP block Other Names: •Naropin

干预措施: Ropivacaine (Drug)

Group 2 - 0.25% Ropivacaine

Active Comparator

Patients will receive 0.25% for the TAP block Procedure: ULTRASOUND GUIDED TAP BLOCK Drug: 0.25% ropivacaine 20ml of 0.25% ropivacaine is used to perform the TAP block Other Names: •Naropin

干预措施: Ropivacaine (Drug)

结局指标

主要结局

POSTOPERATIVE PAIN

时间窗: 48 hours

Severity of postoperative pain will be assessed using(VAS) scale. Post-operative pain scale name: Visual Analog Scale (0-10) with 0 being no-pain and 10 being maximum pain.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

kalpana tyagaraj

Residency Program Director

Maimonides Medical Center

研究点 (1)

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