CTRI Number |
CTRI/2021/02/031148 [Registered on: 09/02/2021] Trial Registered Prospectively |
Last Modified On: |
22/04/2021 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of two different types of pain relieving techniques in patients undergoing hip fracture surgery |
Scientific Title of Study
|
Comparison of continuous pericapsular nerve group block versus continuous fascia iliaca block in patients undergoing hip fracture surgery- a randomized double- blind study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Ch Parimal Patel |
Designation |
Junior Resident (Postgraduate trainee) |
Affiliation |
All India Institute of Medical Sciences, New Delhi |
Address |
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All Institute of Medical Sciences, Ansari Nagar East, New Delhi Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All Institute of Medical Sciences, Ansari Nagar East, New Delhi, 110029 South West DELHI 110049 India |
Phone |
9182030551 |
Fax |
|
Email |
dr.parimalpatel@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Kanil Ranjith Kumar |
Designation |
Assistant Professor |
Affiliation |
All Institute of Medical Sciences, New Delhi |
Address |
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All Institute of Medical Sciences, Ansari Nagar East, New Delhi Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All Institute of Medical Sciences, Ansari Nagar East, New Delhi, 110029 South West DELHI 110029 India |
Phone |
8800314575 |
Fax |
|
Email |
kanil.aiims@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Kanil Ranjith Kumar |
Designation |
Assistant Professor |
Affiliation |
All Institute of Medical Sciences, New Delhi |
Address |
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All Institute of Medical Sciences, Ansari Nagar East, New Delhi Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All Institute of Medical Sciences, Ansari Nagar East, New Delhi, 110029 South West DELHI 110029 India |
Phone |
8800314575 |
Fax |
|
Email |
kanil.aiims@gmail.com |
|
Source of Monetary or Material Support
|
Room 5011, Teaching block, Department of Anaesthesiology, Pain medicine and Critical care
All Institute of Medical Sciences, Ansari Nagar East, New Delhi |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences |
Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Ch Parimal Patel |
All Institute of Medical Sciences, New Delhi, Delhi 110029 |
Room 5011, Department of Anaesthesia, Academic block, AIIMS New Delhi 110029 South West DELHI |
9182030551
dr.parimalpatel@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics committee for postgraduate research, AIIMS |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Continuous Fascia iliaca block (cFIB) |
Under USG guided cFIB with 30 ml 0.25% Ropivacaine followed by 0.2% ropivacaine at 5 ml/hr infusion |
Intervention |
Continuous Pericapsular nerve group block
(cPENG) |
Under USG guided cPENG with 20 ml 0.25% Ropivacaine followed by 0.2% ropivacaine at 5 ml/hr infusion |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
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
|
|
ExclusionCriteria |
Details |
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
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To measure total fentanyl requirements in continuous pericapsular nerve group block versus continuous fascia iliaca block |
48 hours post operative |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare the following between two groups
1) To assess NRS pain scores at rest and at 15° leg elevation
2) To compare block related adverse events, in terms of local anaesthetic systemic toxicity, hematoma formation and injection site infections.
|
At 0,15 minutes,30 minutes during surgery and 2, 6, 12, 24 and 48 hours post surgery |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 3/ Phase 4 |
Date of First Enrollment (India)
|
15/02/2021 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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. |