| CTRI Number |
CTRI/2025/02/081042 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Post operative pain relief following hip surgeries in comparison with two commonly used blocks |
|
Scientific Title of Study
|
Analgesic Efficacy and Postoperative Pain Relief: A Comparative Study of Ultrasound-Guided PENG (pericapsular nerve group block ) and Fascia Iliaca Blocks in Hip Fracture Patients Under Spinal Anesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nivedhitha |
| Designation |
Assistant professor |
| Affiliation |
Karpaga Vinayaga institute of Medical Sciences and Research centre |
| Address |
Room no 9 , Department of anaesthesia,
Karpaga vinayaga institute of medical sciences ,chinnakolambakkam division
Madhuranthakam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9486831912 |
| Fax |
|
| Email |
nivedhithaakshaya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nivedhitha |
| Designation |
Assistant professor |
| Affiliation |
Karpaga Vinayaga institute of Medical Sciences and Research centre |
| Address |
Room no 9,departemnt of anaesthesiology,Karpaga vinayaga institute of medical sciences ,chinnakolambakkam divison,
Madhuranthakam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9486831912 |
| Fax |
|
| Email |
nivedhithaakshaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivedhitha |
| Designation |
Assistant professor |
| Affiliation |
Karpaga Vinayaga institute of Medical Sciences and Research centre |
| Address |
room no 9,department of anaesthesia,Karpaga vinayaga institute of medical sciences ,chinnakolambakkam division,
Madhuranthakam
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9486831912 |
| Fax |
|
| Email |
nivedhithaakshaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| karpaga vinayaga institute of medical sciences and research centre ,INDIA .PIN CODE -603308 |
|
|
Primary Sponsor
|
| Name |
Karpaga vinayaga institute of medical sciences |
| Address |
Karpaga vinayaga institute of medical sciences and Research centre ,chengalpattu district,tamilnadu state,INDIA
PIN CODE :603308 |
| Type of Sponsor |
Private medical college |
|
|
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 Nivedhitha |
Karpaga vinayaga institute of medical sciences and research centre |
chinnakolambakkam,chengalpattu
district,tamilnadu state,INDIA.pincode :603308
Kancheepuram
TAMIL NADU |
9486831912
nivedhithaakshaya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karpaga vinayaga institute of medical sciences and research centre ethics comitee(HUMAN STUDIES ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PENG block (PERICPSULAR NERVE GROUP ) block |
positioning for hip fracture patients with supplementary PENG block using ultrasound |
| Comparator Agent |
fascia iliaca block |
giving ultrasound guided fascia iliaca block in hip fracture patients under spinal anesthesia.
fascia iliaca block is the comparator (control) comparing with PENG block (case ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age from 18 to 60 years with hip fractures posted for surgery
Asa 1 -3 |
|
| ExclusionCriteria |
| Details |
Contraindication to regional anaesthesia a
Allergy to local anaesthetics
Not willing to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
to assess the duration of analgesia provided by each block.
to evaluate the requirement of rescue analgesia |
24 hours in the postoperative care |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the impact of both blocks on postoperative functional recovery. |
24 hours in the postoperative care |
|
|
Target Sample Size
|
Total Sample Size="73"
Sample Size from India="73"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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="0"
Months="6"
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
|
Hip fractures are common among elderly patients and are associated with significant morbidity and mortality. Effective postoperative pain management is crucial to enhance recovery and reduce complications. Regional anesthesia techniques like the Pericapsular Nerve Group (PENG) block and Fascia Iliaca Compartment Block (FICB) have gained attention due to their potential to provide superior pain relief while minimizing systemic opioid use. This study aims to compare the analgesic efficacy of these two blocks in the context of postoperative pain relief for hip fracture surgeries under spinal anesthesia |