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临床试验/CTRI/2022/11/047402
CTRI/2022/11/047402尚未招募不适用

To evaluate the effect of epidural volume extension with saline in combined spinal epidural for lower limb surgeries using intrathecal ropivicaine with fentanyl

SARDAR PATEL MEDICAL COLLEGE, BIKANER1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月20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
60
试验地点
1
主要终点
SENSORY- LEVEL ,ONSET ,DURATION

研究概览

简要总结

We will conduct a study in 60 patients belonging ASA grade I and II aged between 45 to 65 years undergoing lower limb surgeries in Sardar Patel medical college, Bikaner(Rajasthan). This study will be aimed to identify the effectiveness of block profile provided by extending the epidural volume with normal saline for lower limb orthopaedic surgeries using a low dose intrathecal hyperbaric ropivacaine without causing hemodynamic changes. The majority of lower extremity orthopaedic surgery patients are old age and have multiple coexisting medical problems. Ensuring hemodynamic stability in these patients requires selection of appropriate techniques of regional anaesthesia, focussing on maintaining a safe and desirable level of blockade and limiting extensive sympathectomy.Combined spinal epidural anaesthesia will be given to both groups.Spinal anaesthesia will be given low dose isobaric 0.75% Ropivicaine. Group A will receive 10 ml of normal saline after 5 mins of intrathecal drug administration(EVE). Group B will not receive EVE

A. PRIMARY AIM-

• To assess and to compare the sensory blockade in terms of onset, level and regression.

• To assess and to compare the motor blockade in terms of onset level and recovery. • To compare the time at which first rescue analgesia is given epidurally.

B. SECONDARY AIM-

• To observe the haemodynamic parameters. • To observe patient and surgeon satifaction. • To observe any side effects and complications related to drugs.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Investigator Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • ASA 1 AND 2 HEIGHT 150 TO 170 CM WEIGHT 40 TO 75 PATIENT UNDERGOING ELECTIVE LOWER LIMB SURGERIES.

排除标准

  • ASA 3 AND 4, PATIENT REFUSAL,PRE-EXISTING NEUROLOGICAL DISEASE, COAGULOPATHY, SURGEREIES MORE THAN 3 HRSINFECTION AT INJECTION SITE,.

结局指标

主要结局

SENSORY- LEVEL ,ONSET ,DURATION

时间窗: O MIN, 5 MINS 10 MINS 15 MINS, 30 MINS 45 MINS, 60 MINS 2HRS 4 HRS 6 HRS 8 HRS

MOTOR-ONSET,DURATION

时间窗: O MIN, 5 MINS 10 MINS 15 MINS, 30 MINS 45 MINS, 60 MINS 2HRS 4 HRS 6 HRS 8 HRS

次要结局

  • HAEMODYNAMIC PARAMETERS,PATIENT SATISFACTION,SIDE EFFECTS(FIRST 24 HOURS)

研究者

发起方
SARDAR PATEL MEDICAL COLLEGE, BIKANER
申办方类型
Government medical college

研究点 (1)

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