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临床试验/CTRI/2018/01/011163
CTRI/2018/01/011163尚未招募不适用

Evaluation of Efficacy of Ultrasound Guided Transversus Abdominis Plane Block in Multimodal Regimen for Postoperative Analgesia after Total Abdominal Hysterectomy done under Combined Spinal Epidural Anaesthesia.

Tata Motors Hospital1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2018年1月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
74
试验地点
1
主要终点
Duration of analgesia

研究概览

简要总结

This study is a randomized, double blind, parallel group, evaluating efficacy of  Ultrasound guided Transversus Abdominis Plane (TAP) block in multimodal regimen after total abdominal hysterectomy patients done under combined spinal epidural aneasthesia technique in India. Subjects randomized in to two groups, Control group will receive standard postoperative analgesic treatment while study group will receive standard postoperative analgesic treatment and TAP block. The primary outcome measure will be assessment of duration of analgesia postoperatively within 24 hours. Secondary outcomes will be epidural morphine consumption, pain severity using visual analogue scores, Incidence of nausea-vomiting, pruritus, sedation and respiratory depression, complication of TAP block, Adverse effect of drug and patient satisfaction at 0, 2, 4, 6, 8, 10, 12, 18 and 24 hours.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
Female

入选标准

  • All patients undergoing total abdominal hysterectomy under combined spinal epidural anaesthesia after obtaining informed consent.
  • ASA grade I-III.
  • Total abdominal hysterectomy performed via lower abdominal transverse (Pfannenstiel) incision.

排除标准

  • Patient refusal.
  • A history of drug allergy or local anaesthetic toxicity.
  • BMI >35kg/m2 (to limit maximum Ropivacaine dose to 3mg/kg) Contraindications to regional anaesthesia (bleeding diathesis, infection at the site of block and peripheral neuropathy) Change of anaesthetic technique to general anaesthesia.
  • Failure or complication in epidural catheter insertion.

结局指标

主要结局

Duration of analgesia

时间窗: 0,2,4,6,8,10,12,18 and 24 hr.

次要结局

  • Epidural morphine consumption.(Severity of pain.)

研究者

发起方
Tata Motors Hospital
申办方类型
Private hospital/clinic

研究点 (1)

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