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临床试验/CTRI/2019/10/021579
CTRI/2019/10/021579尚未招募不适用

Comparative study of effectiveness of femoral nerve block versus Intravenous Nalbuphine in positioning of patients of Intertrochanteric fractures for Spinal anaesthesia.

DrPragna Doppalapudi1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年1月11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
70
试验地点
1
主要终点
To compare the effect of femoral nerve block vs intravenous Nalbuphine for the ease of patient positioning and relief of pain in patients of intertrochanteric fractures undergoing spinal anaesthesia.

研究概览

简要总结

INTRODUCTION:

Fracture of femur is a common orthopedic problem following trauma in patients of all age groups and spinal anaesthesia is a preferred technique for providing anaesthesia.

Correct positioning during spinal anaesthesia is the pre-requisite for a successful procedure.Extreme pain and limb immobility are deterrants to an ideal positioning for performing the spinal anaesthesia.

Various modalities like the use of intravenous opioids,peripheral nerve blocks have been advocated pre-operatively to reduce the pain during positioning for anaesthesia.

There are very few literatures available regarding superiority of one technique over the other.So,we are conducting this study to compare the effectiveness of femoral nerve block versus intravenous Nalbuphine in positioning of patients of intertrochanteric fractures for spinal anaesthesia.

AIMS AND OBJECTIVES OF STUDY:

Aim: To evaluate the effectiveness of femoral nerve block versus Intravenous Nalbuphine in positioning of the patients with intertrochanteric fractures for spinal anaesthesia

Primary objective: Ease of positioning of patients for spinal anaesthesia

---Quality of patient position as assessed by anaesthesiologist satisfaction.(0=not satisfactory;1=satisfactory;2=good;3=optimal)

---Assessment of pain carried out by Visual analogue scale before and during procedure of positioning.

Secondary objective:

---Time taken to perform spinal anaesthesia between both groups of patients

---Patient satisfaction  while positioning.(yes/no)

 Methodology and Materials:

Place of study: The study will be conducted in Department of Anaesthesiology at Kalinga institute of medical sciences,Bhubaneswar, Odisha.

Instituitional approval and informed consent from patients will be taken before performing the procedure and prior to the study.

Study design**:** Randomized study

Sample size**:**Considering the power of study to be 80% and level of significance (alpha=0.05) estimated required sample size is 70, 35 being in each group.

Inclusion criteria:

-Age group 18-80 years;of either sex

ASA I,II scheduled for intertrochanteric fracture surgeries under spinal anaesthesia.

-patients who give a valid informed consent

Exclusion criteria:

-Any contra-indication for spinal anaesthesia, femoral nerve block or use of opioids/ local anaesthetics

-patients with polytrauma,infection over injection site

-patients who refuse for participation in study

Randomisation and allocation:

Randomization will be done by computer generated randomization list.Then patients will be allocated to one one of the two groups by opaque sealed envelope technique and will recieve either of two regimen.

Methodology:

Patients will be shifted to pre-operative area.Monitor with NIBP,SpO2,ECG will be connected.Then,

patients will be classified into two groups:

Group A: patients will receive intravenous(IV) Nalbuphine in a dose of 0.1mg/kg bodyweight 15 minutes prior to positioning

  Group B: patients will receive PNS guided using B braun nerve stimulator or USG GUIDED Femoral nerve block(FNB) with 20ml of 0.2% Ropivacaine 15 minutes prior to positioning for spinal anaesthesia. Then patients will be shifted to operation theatre. Monitors will be placed and thereafter, a spinal block will be performed . Block will be given in L2-L3 or L3-L4 space via midline/paramedian approach in sitting position. Pain assessment will be done before and during positioning using Visual analogue scale(0=NO pain to 10=max. Pain)

-The time taken to perform the spinal anaesthesia;

-Anaesthesiologist’s satisfaction with patient position maintained for spinal block

Satisfaction scores marked on visual analog scale

VAS     SATISFACTION SCORE

0    -  Not satisfactory

1    -  satisfactory

2    -  good

3    -  optimal

-Patient satisfaction will also be noted in both groups of patients(Yes/No)

-Vital parameters:Heart rate,SBP,DBP,MAP,Spo2 will be monitored.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age group 18-80 years;of either sex -ASA I,II scheduled for intertrochanteric fracture surgeries under spinal anaesthesia.
  • patients who give a valid informed consent.

排除标准

  • Any contra-indication for spinal anaesthesia, femoral nerve block or use of opioids/ local anaesthetics -patients with polytrauma,infection over injection site -patients who refuse for participation in study.

结局指标

主要结局

To compare the effect of femoral nerve block vs intravenous Nalbuphine for the ease of patient positioning and relief of pain in patients of intertrochanteric fractures undergoing spinal anaesthesia.

时间窗: 0,2,5,10,15,20 minutes,during positioning

次要结局

  • To assess the time taken to perform spinal anaesthesia between both groups of patients.(To assess patients acceptance.)

研究者

发起方
DrPragna Doppalapudi
申办方类型
Other [self]

研究点 (1)

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