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临床试验/CTRI/2017/05/008588
CTRI/2017/05/008588尚未招募不适用

Comparative Study Between Intrathecal Nalbuphine and Fentanyl as adjuvant with Ropivacaine in lower limb surgeries: A Prospective, Randomized,Double Blind Study

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年6月19日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Duration of Analgesia and block characteristics

研究概览

简要总结

Intrathecal opoids are synergistic with local anaesthtics and intensify the sensory block without increasing the sympathetic block. They are commonly added to local anaesthetic for potentiating their effects, reducing their doses, and thereby reducing their complication and side effect. They also prolong the duration of post operative analgesia. Few studies investigated intrathecal nalbuphine with hyberbaric bupivacaine , and as for as we know, no study had been done using isobaric ropivacaine as local anaesthetic and intrathecal nelbuphine are added as adjuant  and compared for it postoperative analgesic effects with fentanyl.

The study is a randomized, double blind, parallel group trial comparing effeicacy and safety of intrathecal nalbuphine 500mcg and Fentanyl 25mcg with newer local anaesthetics isobaric Ropivacaine. The patient will be divided randomly using computer generated number  into two equal groups (n=50) : Group RN will receive 0.75% ropivacaine (2.5ml) and 0.5ml nalbuphine (500mcg), Group RF will receive 0.75% of ropivacaine (2.5ml) 0.5ml fentanyl (25mcg). All patients are clinically assessed and routein preop. investigation will be done before procedure.  Baseline parameter will be noted on arrival to OT room or preop room. All patient will be pre-loaded with Ringer solution 10ml/kg  before procedure. Under all aseptic and antiseptic precaution dural puncture was performed in sitting position in L3-L4 interspce with a 25 G Quinke spinal needle. Intraoperatively HR, NIBP, RR, SpO2 were recorded  at 5 minute interval. Primary outcome measures will be duration of analgesia and Block characteristics ( onset and duration of sensory and motor block). The secondary outcome will be changes in hemodynamics and adverse side effects.

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
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients aged between 18 to 60 yrs with ASA I & II, of either sex, undergoing lower limb surgeries.

排除标准

  • Pre-existing neurological deficit/peripheral neuropathy -Coagulation disorders -Local infection at the site of block.
  • Pregnancy -History of allergy to amide local anesthetics -Patient refusal to participate in the study -Patient having cardio or respiratory system failure -Uncooperative patients.
  • Patient with h/o end organ damage.

结局指标

主要结局

Duration of Analgesia and block characteristics

时间窗: 12 hr.

次要结局

  • Hemodynamics and adverse event(12 hr.)

研究者

发起方
未提供

研究点 (1)

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