| CTRI Number |
CTRI/2024/12/078432 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two nerve blocks-Pericapsular Nerve Block(PENG( and Suprainguinal Fascia Iliaca Block(SFICB) outcome is to find which is better in reducing pain during positioning for Spinal Anaesthesia in Hip fracture patients |
|
Scientific Title of Study
|
Comparison of Ultrasound Guided Pericapsular Nerve(PENG) Block and Suprainguinal Fascia Iliaca(SFICB) Block for Attenuating Positioning Pain during Spinal Anaesthesia in Hip Fracture patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ROSHEEN S BABU |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
ROOM NO:301
DEPARTMENT OF ANAESTHESIA
ABVIMS AND DR RML HOSPITAL
NEW DELHI
New Delhi
DELHI
110010
India |
| Phone |
9846657401 |
| Fax |
|
| Email |
rosheensbabu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANDEEP KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
ROOM NO.301
DEPARTMENT OF ANAESTHESIA
ABVIMS AND DR RML HOSPITAL
NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9868910835 |
| Fax |
|
| Email |
drsandeeprml@gmaIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR SANDEEP KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
ABVIMS AND DR RML HOSPITAL |
| Address |
ROOM NO:301
DEPARTMENT OF ANAESTHESIA
ABVIMS AND DR RML HOSPITAL
NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9868910835 |
| Fax |
|
| Email |
drsandeeprml@gmaIL.COM |
|
|
Source of Monetary or Material Support
|
| Atal Bihari Vajpayee Institute of Medical Sciences AND DR RML Hospital.
New Delhi,India
Pin-110001 |
|
|
Primary Sponsor
|
| Name |
DR ROSHEEN S BABU |
| Address |
ROOM NO:301
DEPARTMENT OF ANAESTHESIA
ABVIMS AND DR RML HOSPITAL
NEW DELHI
110001 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DR ROSHEEN S BABU |
ABVIMS AND DR RML HOSPITAL |
ROOM NO:301
DEPARTMENT OF ANAESTHESIA,
ABVIMS AND DR RML HOSPITAL,
BABA KHARAK SINGH MARG,
CONNAUGHT PLACE,
NEW DELHI
110001
New Delhi
DELHI |
9846657401
rosheensbabu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR RML HOSPITAL NEW DELHI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pericapsular Nerve Block( PENG) and Suprainguinal Fascia Iliaca Block(SFICB) |
Preoperatively 30 minutes before positioning for Spinal Anaesthesia in Hip fracture patients, group A patients will be given Pericapsular Nerve Block( PENG) using 25ml 0.25% bupivacaine and group B patients will be given Suprainguinal Fascia Iliaca Block(SFICB) with 25ml 0.25% bupivacaine based on computer randomization. Patient will be monitored postoperatively for 24 hrs |
| Intervention |
To asses the post operative pain while comparing PENG Block and Suprainguinal fascia iliaca block |
Preoperatively 30 minutes before positioning for Spinal Anaesthesia in Hip fracture patients, group A patients will be given Pericapsular Nerve Block( PENG) using 25ml 0.25% bupivacaine and group B patients will be given Suprainguinal Fascia Iliaca Block(SFICB) with 25ml 0.25% bupivacaine based on computer randomization. Patient will be monitored postoperatively for 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing hip fracture surgeries
ASA1 and 2 |
|
| ExclusionCriteria |
| Details |
1) Known allergy to local anaesthetic agent
2)Infection at puncture site
3)known coagulopathy
4)spine deformity or previous surgery on hip or spine
5)known case of ischemic heart disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)NRS at rest and on passive 15 degree limb lifting 30 minutes after the blocks |
Baesline and 30 minutes after giving the blocks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) EOSP
2)total duration of analgesia
3)total doses of tramadol used( number of rescue doses) |
30 minutes after giving the blocks and 24 hrs post operatively |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized control trial to compare the Ultrasound guided Pericapsular Nerve Block(PENG) and Suprainguinal Fascia Iliaca Block( SFICB) for attenuating positioning pain during spinal Anaesthesia in Hip fracture patients to be conducted at ABVIMS & DR RML HOSPITAL,New Delhi-110001
Sample size:44 ( 22 in each group)
The primary objective is to compare the Ultrasound guided Pericapsular Nerve Block(PENG) and Suprainguinal Fascia Iliaca Block (SFICB) using NRS( Numerical Rating Score) for attenuating positioning pain during spinal anaesthesia in hip fracture patients.
The secondary objective is to compare duration of post op analgesia and requirement of Tramadol consumption in 24 hr period. |