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临床试验/CTRI/2022/09/045414
CTRI/2022/09/045414招募中不适用

A Prospective Randomised Study to Compare the Efficacy of Intrathecal Bupivacaine 0.5% and Intrathecal 0.75% Ropivacaine in Lower Abdominal and Lower Limb Surgeries

Dr Rochana Bakhshi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年9月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Onset and duration of motor and sensory block

研究概览

简要总结

This prospective randomised studywill be conducted in Dr D.Y.Patil hospital & medical college , Navi Mumbai,Department of Anesthesiology, after institutional ethics committee clearance.

The study population will berandomly divided into two groups.

Group 1(SR) ,n=45: will receive3.2ml of 0.75% Ropivacaine heavy

Group 2(SB), n=45: will receive3.2ml of 0.5% Bupivacaine heavy

The patients will be subjected to apreoperative anesthesia check.

Written informed consent willbe obtained before starting any study procedures.

Proper fasting guidelines will beexplained a day prior to surgery.

On the day of surgery Afterchecking the patient’s written informed consent and adequate NBM status, thepatient will be wheeled in operation theatre. The baseline preoperativeparameters would be recorded before inducing anaesthesia. ,intravenous cannula20gauge(G) or 18 gauge will be inserted on the upper extremity.Intravenous  fluid ,ringer lactate will be started.

Routine  IntraoperativeMonitoring such as

pulse oximeter (SpO2),

electrocardiogram (ECG),

non -invasive blood pressure(NIBP) will be done

Hypotension (20% decrease in MAP),if any, will be treated with intermittent boluses of intravenous ephedrine (6mg)

Bradycardia (HR < 50/ minute)will be treated with intravenous atropine 0.6 milligram (mg) or Glycopyrrolate0.2mg.

Patients will receive spinalanesthesia in sitting position, under aseptic precautions with 25G, Quincketip, spinal needle, by a qualified anesthesiologist.

Group 1 will receive intrathecal3.2 ml of 0.75% Ropivacaine and group 2 will receive intrathecal 3.2ml of 0.5% Bupivacaine.

Patients will be positioned supineimmediately.

Sensory block and level will bechecked using a 25 G hypodermic needle.

Heart rate (HR), systolic (SBP) , diastolic(DBP)and mean arterial pressure (MAP) will be measured every 2 mins from theonset of block for the first 20 mins, thereafter every 10 minutes till the endof the procedure.

Onset of motor blockwill be defined as time frominjection till motor paralysis equivalent to Bromage score 3.

Duration of sensory blockwill be defined as thetime between onset of sensory block to return of touch sensation at L1.

Duration of motor blockwill be defined as thetime between onset of motor block to complete return of motor power (Bromage 0).

Duration of analgesia will be defined as the timefrom commencement of block to time when patient first demand rescue analgesia(VAS > 4).

Pain assessment will be done by using visual analogue scale

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing lower limb and lower abdominal surgeries 2.

排除标准

  • ASA III & IV
  • Patients not consenting for spinal anesthesia
  • Spine abnormalities in the patient
  • Coagulation disorders
  • Patients with recent history of raised intracranial pressure.

结局指标

主要结局

Onset and duration of motor and sensory block

时间窗: Immediate (Every two minutes for 20 minutes after administration)

次要结局

  • Hemodynamic parameters (SBP, DBP, MAP, HR)(Immediate (Every two minutes for 20 minutes after administration))
  • Adverse events(From time of administration till wearing off of spinal anesthesia)

研究者

发起方
Dr Rochana Bakhshi
申办方类型
Other [self]

研究点 (1)

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