| CTRI Number |
CTRI/2025/12/099721 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing 0.25% LEVOBUPIVACAINE and 0.25% ROPIVACAINE IN PENG BLOCK FOR PATIENT POSITIONING DURING SUBARACHNOID BLOCK IN HIP FRACTURE SURGERY |
|
Scientific Title of Study
|
0.25% LEVOBUPIVACAINE VERSUS 0.25% ROPIVACAINE IN PENG BLOCK FOR PATIENT POSITIONING DURING SUBARACHNOID BLOCK IN HIP FRACTURE SURGERY: RANDOMISED COMPARATIVE STUDY. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Gupta |
| Designation |
Professor |
| Affiliation |
Rohilkhand Medical College |
| Address |
Room no 2062 Anaesthesia Department Rohilkhand Medical college Bareilly Uttar Pradesh
Bareilly Uttar Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9935312219 |
| Fax |
|
| Email |
akku165@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayur Masudi |
| Designation |
Junior Resignation |
| Affiliation |
Rohilkhand medical college bareilly Pradesh |
| Address |
Department of Anaesthesiology Rohilkhand medical college Bareilly Uttar pradesh
Rohilkhand medical college bareilly Pradesh
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9632638874 |
| Fax |
|
| Email |
Mayurm506@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayur Masudi |
| Designation |
Junior Resignation |
| Affiliation |
Rohilkhand medical college bareilly Pradesh |
| Address |
Department of Anaesthesiology Rohilkhand medical college Bareilly Uttar pradesh
Rohilkhand medical college bareilly Pradesh
UTTAR PRADESH
243006
India |
| Phone |
9632638874 |
| Fax |
|
| Email |
Mayurm506@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rohilkhand medical college bareilly Pradesh |
| Address |
Rohilkhand medical college bareilly Pradesh
243006 |
| 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 Mayur Masudi |
Rohilkhand medical college |
Department of anaesthesiology Rohilkhand medical college ,Bareilly
Bareilly
UTTAR PRADESH |
9632638874
Mayurm506@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , RMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, (2) ICD-10 Condition: I788||Other diseases of capillaries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1-2
|
|
| ExclusionCriteria |
| Details |
Allergic to LA
Infection at the site of injection
Coagulopathy and bleeding disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of drug in 12months |
Effectiveness of drug |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/01/2026 |
| 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
|
In peng block the role of positioning of patient under subarachnoid block in hip fracture surgery using levobupivacaine vs ropivacaine |