We are comparing the decease in pain sensation after giving Femoral nerve block and Nalbuphine intravenously in patients with intertrochanteric fractures

Not yet recruiting

• Conditions: Disorder of continuity of bone,

• Registration Number: CTRI/2019/10/021579
• Lead Sponsor: DrPragna Doppalapudi

Brief Summary

**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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-10
• Study Start: 2019-01-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	0,2,5,10,15,20 minutes,during positioning

Secondary Outcome Measures

Name	Time	Method
To assess the time taken to perform spinal anaesthesia between both groups of patients.	To assess patients acceptance.

Trial Locations

Locations (1)

Kalinga institute of medical sciences; 🇮🇳 Khordha, ORISSA, India

Kalinga institute of medical sciences

🇮🇳Khordha, ORISSA, India

DrAmrita Panda

Principal investigator

9439862335

amritapanda1323@gmail.com