Comparison of two different types of pain relieving techniques in patients undergoing hip fracture surgery

Phase 3

Recruiting

• Conditions: Fracture of head and neck of femur,

• Registration Number: CTRI/2021/02/031148
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Brief Summary:

The aim of the study is to compare the analgesic effect of continuous pericapsular nerve group block (cPENG) and continuous fascia iliaca block (cFIB) in hip fracture patients. The subject and the anaesthetist performing the block will be blinded to the type of block the subject receives. Patients aged 18 years or older with hip fracture scheduled for surgical treatment only under spinal anaesthesia will be assessed for eligibility to participate in the study. Patients with allergy to local anaesthesia, severe medical illness with end-organ damage, ASA physical status Grade III and IV will be excluded from the study trial.

The followings will be assessed: subject’s vitals and numerical rating pain scale before and after nerve block at different time points (15 minutes, 30 minutes and during positioning for spinal anaesthesia). Block success is assessed 30 minutes post nerve block procedure if the patient’s pain score on the numerical rating scale drops by 2 points. Ease of positioning patient for spinal anaesthesia is assessed by a grading score and additional fentanyl requirements needed for positioning is noted. Once the block is given, catheter is inserted in both groups and ropivacaine 0.2% at 5ml/hr infusion is started. All patient will receive paracetamol 1gm, 8hourly for 48 hours post spinal placement.

Patients are monitored post their surgery at regular intervals of 2,6,12,24 and 48 hours to assess their pain scores and to note the additional fentanyl requirements they might need during this time frame. Any breakthrough pain measured with numerical rating scale more than 4 will be treated with 0.5 mcg per kg fentanyl.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-15
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1)ASA physical status grade I and II patients 2)Greater than 18 years of age 3)Patients undergoing an operation for neck of femur, sub-capital and intertrochanteric fracture under spinal anaesthesia.

Exclusion Criteria

1)Patient refusal 2)ASA physical status III and IV 3)Known allergy to local anesthetics 4)Local site infection 5)Severe kidney and liver disease 6)Severe cardiac illness (NYHA Class III and IV) 7)Pre-operative opioid tolerance 8)Intrathecal morphine receivers 9)Postoperative epidural infusion receivers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure total fentanyl requirements in continuous pericapsular nerve group block versus continuous fascia iliaca block	48 hours post operative

Secondary Outcome Measures

Name	Time	Method
To compare the following between two groups	1) To assess NRS pain scores at rest and at 15° leg elevation

Trial Locations

Locations (1)

All Institute of Medical Sciences, New Delhi, Delhi 110029; 🇮🇳 West, DELHI, India

All Institute of Medical Sciences, New Delhi, Delhi 110029

🇮🇳West, DELHI, India

Ch Parimal Patel

Principal investigator

9182030551

dr.parimalpatel@gmail.com