| CTRI Number |
CTRI/2020/07/026782 [Registered on: 25/07/2020] Trial Registered Prospectively |
| Last Modified On: |
18/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of pericapsular nerve group block with fascia iliaca block in adult patients undergoing hip surgeries |
|
Scientific Title of Study
|
Comparison of pericapsular nerve group block with fascia iliaca block in adult patients undergoing hip surgeries - A double blinded randomized control 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 Vanishree Alwandikar |
| Designation |
MD ANAESTHESIA POST GRADUATE STUDENT |
| Affiliation |
S NIJALINGAPPA MEDICAL COLLEGE |
| Address |
1st year anaesthesia resident
department of anaesthesia
S N Medical college
bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9480714333 |
| Fax |
|
| Email |
vani.alwandikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Y Hulakund |
| Designation |
Professor and Head of department |
| Affiliation |
S NIJALINGAPPA MEDICAL COLLEGE |
| Address |
Department of anaesthesiology
S N Medical college
bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9901098533 |
| Fax |
|
| Email |
hulkunds@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanishree Alwandikar |
| Designation |
MD ANAESTHESIA POST GRADUATE STUDENT |
| Affiliation |
S NIJALINGAPPA MEDICAL COLLEGE |
| Address |
1st year anaesthesia resident
department of anaesthesia
S N Medical college
bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9480714333 |
| Fax |
|
| Email |
vani.alwandikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL AND RESEARCH CENTER |
|
|
Primary Sponsor
|
| Name |
S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL AND RESEARCH CENTER |
| Address |
S NIJALINGAPPA MEDICAL COLLEGE AND HSK HOSPITAL
BAGALKOT 587102 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| vanishree alwandikar |
HSK Hospital |
Department of anaesthesiology
2nd floor Major OT complex S Nijalingappa Medical College and HSK Hospital Bagalkot
Bagalkot
KARNATAKA |
9480714333
vani.alwandikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC instituitional ethics committee on human subjects 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
procedure :Fascia iliaca block |
Fascia iliaca block given with 30ml of 0.25% inj.bupivacaine under ultrasound guidance |
| Intervention |
Procedure :pericapsular nerve group block |
pericapsular nerve group block given with 20ml of 0.25% inj. bupivacaine under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2
body mass index <30
patients undergoing hip surgeries |
|
| ExclusionCriteria |
| Details |
Patients refusal to give consent
Infection at the site of injection
Allergy to local anesthetics
patients receiving opioids for chronic analgesic therapy
coagulopathy
patients with inguinal hernias on the same side of hip pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score will be assesed at rest and with passive leg raise to 15 degrees |
30 minutes after block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate
Non invasive blood pressure(NIBP)
Respiratory rate |
30 minutes after block |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
31/07/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The objective of this randomized control study is to compare the analgesic effect provided by pericapsular nerve group block and fascia iliaca block prior to positioning of patients for hip surgeries under spinal anaesthesia. |