| CTRI Number |
CTRI/2019/09/021121 [Registered on: 09/09/2019] Trial Registered Prospectively |
| Last Modified On: |
06/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between peripheral nerve stimulator and ultrasound for giving femoral nerve block in patients undergoing acl,pcl and meniscal repair surgeries |
|
Scientific Title of Study
|
A Comparitive Study Between Peripheral Nerve Stimulator VS Ultrasound Guided Femoral Nerve Block For Post Operative Pain Management in Knee Arthroscopy Procedures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gunupuru Bharat |
| Designation |
Post Graduate (Second Year) |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology,Kalinga Institute Of Medical Sciences,KIIT University ,Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9538948337 |
| Fax |
|
| Email |
bharat3636@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akshay Kumar Parida |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology,Kalinga Institute Of Medical Sciences,KIIT University ,Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9861007297 |
| Fax |
|
| Email |
drakparida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Kumar Parida |
| Designation |
Professor |
| Affiliation |
Kalinga Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology,Kalinga Institute Of Medical Sciences,KIIT University ,Bhubaneswar
Khordha
ORISSA
751024
India |
| Phone |
9861007297 |
| Fax |
|
| Email |
drakparida@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology,Kalinga Institute Of Medical Sciences,KIIT University,Patia,Bhubaneswar,Odhisha,752104 |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology |
| Address |
Kalinga Institute Of Medical Sciences Patia Bhubaneswar 751024 |
| 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 |
| Gunupuru Bharat |
Kalinga Institute Of Medical Sciences |
Department Of Anesthesiology
Khordha
ORISSA |
9538948337
bharat3636@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee kalinga institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral Nerve Block |
Comparison Betwwen Ultrasound and Peripheral Nerve Stimulator to Know Which Intervention has Greater Efficacy in Giving Femoral Nerve Block |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing Patients
2.Patients With ASA Physical Status 1,2&3
3.Patients Posted For Knee Arthroscopy
4.Patients Aged Between 16&65 |
|
| ExclusionCriteria |
| Details |
1.Abnormal Coagulation Profile 2.History Of Allergy to Local Anaesthetic
3.Opioid & Alcohol Abuse
4.Psychiatry Patients. 5.Obese Patients With BMI More Than Or Equal to 40 6.Patients With ASA Physical Status 4&5 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Number of repositionings required
2.Time taken to perform the technique
3.Onset and duration of effect of block
4.Effectiveness of the technique
|
0minutes,3minutes,6minutes,9minutes,12minutes,15minutes after performing the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Patient satisfaction
2.Complcations(arterial puncture,hematoma,unintended parasthesia) |
0minutes,3minutes,6minutes,9minutes,12minutes,15minutes after performing the block |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2019 |
| 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
|
To compare the efficacy of peripheral nerve stimulator vs ultrasound guided femoral nerve block for post operative pain management in knee arthroscopy procedures. |