| CTRI Number |
CTRI/2024/07/071078 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Pericapsular nerve group block and Quadratus lumborum block in proximal femur fractures |
|
Scientific Title of Study
|
POST-OPERATIVE ANALGESIA AND OPIOID-SPARING EFFICACY OF
ULTRASOUND-GUIDED PERICAPSULAR NERVE GROUP (PENG) BLOCK
VERSUS QUADRATUS LUMBORUM BLOCK (Q.L.B.) IN PROXIMAL FEMUR FRACTURE PATIENTS: A COMPARATIVE STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAHINI VENKATA LAKSHMI NARASIMHA SESHA SAI |
| Designation |
JUNIOR RESIDENT, ANAESTHESIOLOGY |
| Affiliation |
Shri B M Patil Medical College, Vijayapura |
| Address |
Department of Anaesthesiology,Shri B M Patil Medical College,
Bangaramma Sajjan Campus,Vijayapura
Bijapur
Department of Anaesthesiology,Shri B M Patil Medical College,
Bangaramma Sajjan Campus,Vijayapura
Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
8919132777 |
| Fax |
|
| Email |
sahiniseshasai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K NIRMALA DEVI |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE & HOSPITAL |
| Address |
THIRD FLOOR OT COMPLEX
THIRD FLOOR OT COMPLEX
Bijapur
KARNATAKA
586103
India |
| Phone |
8217618954 |
| Fax |
|
| Email |
nirmalakagalkar77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahini Venkata Lakshmi Narasimha Sesha Sai |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE , Vijayapura |
| Address |
THIRD FLOOR OT COMPLEX
THIRD FLOOR OT COMPLEX
Bijapur
KARNATAKA
586103
India |
| Phone |
8919132777 |
| Fax |
|
| Email |
sahiniseshasai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College,Bangaramma Sajjan Campus,BLDE
University,Vijayapura,Karnataka,Pin 586103 |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College |
| Address |
Bangaramma Sajjan Campus,BLDE
University,Vijayapura,Karnataka,Pin 586103 |
| 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 SAHINI VENKATA LAKSHMI NARASIMHA SESHA SAI |
Shri B M Patil Medical College |
Department of
Anaesthesiology,
Bangaramma Sajjan
Campus,BLDE
University,Vijayapura,
Bijapur
KARNATAKA
Bijapur
KARNATAKA |
8919132777
sahiniseshasai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI B M PATIL MEDICAL COLLEGE & HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: W19||Unspecified fall, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMPARISON OF EFFICACY OF PERICAPSULAR NERVE GROUP BLOCK AND QUADRATUS LUMBORUM BLOCK |
TIME AT WHICH THE RESCUE ANALGESIA IS GIVEN TO PATIENT. |
| Intervention |
PENG BLOCK AND QUADRATUS LUMBORUM BLOCK |
AFTER ADMINISTERING PERICAPSULAR NERVE GROUP BLOCK TO ONE GROUP AND QUADRATUS LUMBORUM BLOCK TO ANOTHER GROUP AND COMPARED WITH NO BLOCK GROUP BY VISUAL ANALOGUE SCALE (VAS) SCORE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. PROXIMAL FEMUR SURGERIES
2. ASA GRADE I & II |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Pregnant women
3. Patients with cardiopulmonary disorders
4. Patients with hepatic and renal disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative visual analogue scale (VAS) score |
12, 24, 48 hours in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| requirement of rescue analgesia |
24 and 48hrs postoperatively |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "84"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
03/08/2024 |
| Date of Study Completion (India) |
20/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sahiniseshasai@gmail.com].
- For how long will this data be available start date provided 03-02-2024 and end date provided 03-02-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This is a comparative study for post operative analgesia and opioid sparing efficacy ultrasound guided pericapsular nerve block versus quadratus lumborum block for proximal femur fracture patients. primary outcome to compare VAS pain scores post operatively. |