| CTRI Number |
CTRI/2025/04/084207 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pericapsular nerve group block (an innovative nerve block) is beneficial for patients with hip fracture undergoing surgery for perioperative pain relief |
|
Scientific Title of Study
|
Study of effectiveness of Pre induction USG guided pericapsular nerve group(PENG) block in minimizing pain associated with positioning for neuraxial anesthesia in patients with hip fractures: A prospective randomized control study |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BEJOY S GEORGE |
| Designation |
DNB Trainee |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Department of Anesthesia, Operation theater, Street Number 2, near Institutional Area, Sector 3, Rohini, Delhi, 110085
North West
DELHI
110018
India |
| Phone |
8095798748 |
| Fax |
|
| Email |
bejoysgeorge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Abhijeet Khaund |
| Designation |
Senior Consultant |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Department of Anesthesia, Operation theater, Street Number 2, near Institutional Area, Sector 3, Rohini, Delhi, 110085
North West
DELHI
110085
India |
| Phone |
9958995277 |
| Fax |
|
| Email |
abhijeet72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BEJOY S GEORGE |
| Designation |
DNB Trainee |
| Affiliation |
Jaipur Golden Hospital |
| Address |
Department of Anesthesia, Operation theater, Street Number 2, near Institutional Area, Sector 3, Rohini, Delhi, 110085
North West
DELHI
110018
India |
| Phone |
8095798748 |
| Fax |
|
| Email |
bejoysgeorge@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jaipur Golden Hospital Street Number 2, near Institutional Area, Sector 3, Rohini, Delhi, 110085 |
|
|
Primary Sponsor
|
| Name |
Jaipur Golden Hospital |
| Address |
Street Number 2, near Institutional Area, Sector 3, Rohini, Delhi, 110085 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Bejoy S George |
Jaipur Golden Hospital |
Department of Anesthesia, Operation theater, Street Number 2, near Institutional Area, Sector 3, Rohini, Delhi, 110085
North West
DELHI |
8095798748
bejoysgeorge@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Ethics Committee Registry for Biomedical and Health Research |
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, (2) ICD-10 Condition: S721||Pertrochanteric fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C |
Control group will receive a intravenous dose 1 microgram per kg body weight of injection Fentanyl (with dose adjustment of 10 percent reduction at every decade after 60 years) 30 mins prior to surgery |
| Intervention |
Group P |
Pericapsular Nerve Group Block with Ropivacaine 0.25 percent 20ml for perioperative pain relief |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients consenting for the intervention (PENG block) and regional anesthesia
2. Age 20 years to 90 years of either gender
3. ASA grade1,2 or 3
|
|
| ExclusionCriteria |
| Details |
1. Patients’ refusal for regional anesthesia and if any contraindication is present.
2. Any strong contraindication for opioid analgesics like advanced chronic lung disease with respiratory failure, severe OSA etc
3. Allergy to any drug under study.
4. Patients with coagulopathy or on anticoagulants.
5. Patients with evidence of Cardiac failure.
6. Any infection at the site of block
7. Patient unable to communicate
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •To measure and compare the total duration taken for positioning till completion of neuraxial block to evaluate ease of execution and NPRS scoring |
Baseline, 30mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe numerical pain rating scale (NPRS) score, before and after intervention (PENG block/IV opioid) and during positioning for spinal anaesthesia and compare the outcome of the cases with that of control group |
Perioperative |
| To measure and compare the total duration taken for positioning till completion of neuraxial block to evaluate ease of execution. |
Perioperative |
| To study whether preoperative PENG block has any influence on post operative analgesia by noting time for first demand of analgesia after completion of surgery |
24-48 hours |
| To observe the hemodynamic changes from baseline till execution of neuraxial block in both the study and the control group and compare |
Perioperative |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
16/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study is a prospective randomized controlled study, double blind, trial comparing ultrasound guided pericapsular nerve group block with 0.25% ropivacaine and intravenous fentanyl for ease of positioning to administering neuraxial block and pain relief with patients undergoing hip fracture surgeries which will be conducted in Jaipur Golden Hospital in India. The primary outcome is to measure and compare the total duration taken for positioning till completion of
neuraxial block to evaluate ease of execution and NPRS
scores. The secondary outcome Duration
of postoperative analgesia by noting the time for first demand of analgesia
after completion of surgery |