A Clinical Trial to compare two blocks given in the thigh in patients with fracture femur( Long bone of the lower limb)to make it easy for the patients to sit for spinal anesthesia

Phase 4

Not yet recruiting

• Conditions: Other fracture of femur,

• Registration Number: CTRI/2019/03/017964
• Lead Sponsor: Meeta Gupta

Brief Summary

This study is a comparative observational two centre trial, comparing the preoperative ultrasound guided fascia iliaca block versus femoral nerve block in proximal femur fractures before positioning for spinal anesthesia that will be conducted in two centres in India.The primary outcome measures will be level of pain relief by (VAS score) before positioning for spinal  anesthesia ( baseline and at 1, 2, 3, 4 ,5, 10, and 15 minutes) and intraoperative hemodynamics ( heart rate and mean arterial pressure) at 5,10 and 15 minutes between the two groups. The secondary outcomes will be duration of pain relief postoperatively (rescue analgesia)  by VAS score at 2,4,8,12,16,20 and 24 hours and  total analgesic requirement between the two groups in the next 24 hours .

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-03-03
• Study Start: 2019-11-03

Recruitment & Eligibility

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

Inclusion Criteria

• ASA physical status I, II ,III and Emergency patients.
• Planned for proximal femur fracture fixation.

Exclusion Criteria

Patient’s refusal History of allergy to local anaesthetics Coagulopathy or Bleeding diathesis H/o peripheral neuropathy Previous femoral bypass surgery Inguinal hernia Local skin infection.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
level of pain relief by (VAS score) before positioning for spinal anaesthesia ( baseline,at 1,2,3,4,5,10and 15 minutes) between the two groups.	March 15,2019 to December 15,2019
intraoperative hemodynamics ( Heart rate, Mean arterial pressure at 5,10 and 15 minutes) between the two groups.	March 15,2019 to December 15,2019

Secondary Outcome Measures

Name	Time	Method
To compare the duration of pain relief postoperatively (rescue analgesia) by VAS score at 2,4,8,12,16,20 and 24 hrs between the two groups.	To compare the total analgesic requirement in the next 24 hours between the two groups.

Trial Locations

Locations (2)

KMC Hospital ,Ambedkar Circle , Mangalore; 🇮🇳 Kannada, KARNATAKA, India

KMC Hospital ,Attavar, Mangalore; 🇮🇳 Kannada, KARNATAKA, India

KMC Hospital ,Ambedkar Circle , Mangalore

🇮🇳Kannada, KARNATAKA, India

Meeta Gupta

Principal investigator

91-6361214258

guptameeta2016@gmail.com