| CTRI Number |
CTRI/2020/11/029247 [Registered on: 19/11/2020] Trial Registered Prospectively |
| Last Modified On: |
18/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study between two block technique that helps in pain management of hip fracture patients |
|
Scientific Title of Study
|
COMPARISON BETWEEN PERICAPSULAR NERVE GROUP
BLOCK AND FASCIA ILIACA BLOCK FOR POSITIONING IN HIP
FRACTURE PATIENTS BEFORE NEURAXIAL BLOCK– A
RANDOMIZED CONTROLLED PILOT STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SARINA K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PAIN MEDICINE AND CRITICAL CARE
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI
South
DELHI
110029
India |
| Phone |
9072024026 |
| Fax |
|
| Email |
srknandagokulum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrCHHAVI SAWHNEY |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, PAIN MEDICINE AND CRITICAL CARE,ALL INDIA INSTITUTE OF MEDICAL SCIENCES, ANSARI NAGAR EAST,NEW DELHI
South
DELHI
110029
India |
| Phone |
9818357051 |
| Fax |
|
| Email |
drchhavisawhney@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SARINA K |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,PAIN MEDICINE AND CRITICAL CARE
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI
South
DELHI
110029
India |
| Phone |
9072024026 |
| Fax |
|
| Email |
srknandagokulum@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ALL INDIA ISTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
ALL INDIA ISTITUTE OF MEDICAL SCIENCES, 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 |
| SARINA K |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY PAIN MEDICINE AND CRITICAL CARE, ANSARI NAGAR EAST, NEW DELHI, DELHI 110029
New Delhi
DELHI |
9072024026
srknandagokulum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, INSTITUTE ETHICS COMMITTEE |
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 |
COMPARISON BETWEEN PERICAPSULAR NERVE GROUP BLOCK AND FASCIA ILIACA BLOCK |
Comparison between Pericapsular nerve group block and Fascia iliaca block , with 20ml, 0.25% ropivacaine in each group before positioning for neuraxial block in hip fracture patients |
| Intervention |
PERICAPSULAR NERVE GROUP BLOCK, FASCIA ILIACA BLOCK |
Ultrasound guided Pericapsular nerve group block with 20ml 0.25% ropivacaine,Ultrasound guided fascia iliaca block with 20ml 0.25% ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age above 18 years, undergoing surgery for hip fracture under neuraxial block. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Any contraindication to neuraxial block like coagulopathy, local infection, increased ICP, spine trauma etc.
Known allergy to local anaesthetic drugs.
Peripheral neuropathy.
Hemodynamically unstable polytrauma patients.
Patients who are ASA 4 and above.
|
|
|
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 assess and compare the analgesic efficacy of USG guided pericapsular nerve group (PENG) block with fascia iliaca compartment block (FICB) using VAS score during positioning of hip fracture patients within 30 minutes before neuraxial block. |
At 10, 20, 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the quality of positioning in the two groups for neuraxial block which will be assessed by the anaesthesiologist’s satisfaction and spinal angle. |
At 30 minute |
| To compare the patient’s acceptance of the technique. |
At 24 hour |
| To study any complications associated with the block. |
24 hour monitoring |
To compare the postoperative 24-hour analgesic requirement in the two groups.
|
24 hour |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a randomized controlled trial-a pilot study to compare analgesic efiicay between pericapsular nerve group block and fascia iliaca block for positioning in hip fracture patients before neuraxial block using VAS score,sitting angle, anaesthetist satisfaction, patient satisfaction, 24 hour toatal analgesic cosumption. The drug used is 20ml 0.25% ropivacaine in each group,and procedure will be ultrasound guided.There is no comparitive study between these two block ,hence investigator proposed this trial |