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临床试验/NCT00801528
NCT00801528已完成4 期

The Analgesic Efficacy of Continuous Wound Instillation With Diclofenac or Ropivacaine Following Cesarean Section: a Randomized, Double-blind, Placebo Controlled Study

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
75
试验地点
1
主要终点
1)Pain intensity 2)"Rescue" analgesia requirements

研究概览

简要总结

A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound infusion using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision.

详细描述

Study Objective: To assess the analgesic efficacy of diclofenac or ropivacaine when administered via wound infusion.

Design: Prospective, randomized, double-blind, placebo-controlled study. Setting: Large referral hospital. Patients: 75 women recovering from Cesarean section performed via a Pfannenstiel incision.

Interventions: On completion of the surgical procedure, a 15 cm 19G infusion catheter (PAINfusor™, Baxter) will be placed below the fascia. According to a computer generated randomization schedule, patients will be divided into one of three treatment groups (n = 25).

  • In Group Control water for injection will be administered.
  • In Group Ropivacaine 0.2 % ropivacaine will be administered.
  • In Group Diclofenac diclofenac (300 mg/240 ml of water for injection) will be administered.

During the first 6 postoperative hours, a co-investigator will administer "rescue" analgesia (10 ml bolus of infusion drug or rescue morphine). Thereafter, the catheter will be connected to an elastometric pump (LV 10 Infusor, Baxter) filled with either water for injection, ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection). The fluid will be administered as a constant infusion rate (10 mL/hr). Continuous wound infusion will be continued for the subsequent 18 postoperative hours. During this 18 hour period, subcutaneous morphine 4 mg will be administered on patient request for additional analgesia.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Patients undergoing Cesarean section

排除标准

  • A history of clinically significant disease:
  • cardiovascular
  • pulmonary
  • neurologic
  • psychiatric
  • metabolic disease

研究组 & 干预措施

Ropivacaine

Active Comparator

Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr

干预措施: Ropivacaine, Diclofenac, Water for injection (Drug)

Diclofenac

Active Comparator

Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr

干预措施: Ropivacaine, Diclofenac, Water for injection (Drug)

Water for injection

Placebo Comparator

Continuous wound instillation of water for injection at a rate set of 10 mL/hr

干预措施: Ropivacaine, Diclofenac, Water for injection (Drug)

结局指标

主要结局

1)Pain intensity 2)"Rescue" analgesia requirements

时间窗: 24 hours

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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