| CTRI Number |
CTRI/2024/07/070850 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study to demonstrate effectiveness between medicine given at lower back region and
medicine given at mid thigh and lower back thigh region. |
|
Scientific Title of Study
|
Prospective Randomised Comparative Study Efficacy of Ultrasound Guided Popliteal Sciatic Nerve & Adductor Canal Block Versus Unilateral Subarachnoid Block as a Sole Anaesthetic Technique for Lower Limb Surgeries |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avanish kumar vishwakarma |
| Designation |
Junior resident |
| Affiliation |
LLRM Medical College |
| Address |
LLRM Medical College, ground Floor ,roon No-g10, Department Of Anaesthesiology LLRM Medical College,jagriti Vihar Meerut.
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8584998729 |
| Fax |
|
| Email |
akvish92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayant kumar |
| Designation |
Assistant Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of anesthesia, ground floor, room no- G10, Garh Road, LLRM Medical College, Jagriti Vihar Meerut.
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8090038206 |
| Fax |
|
| Email |
malikvijayant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Avanish kumar vishwakarma |
| Designation |
junior resident |
| Affiliation |
LLRM MEDICAL COLLEGE |
| Address |
LLRM Medical College, ground Floor ,roon No-g10, Department Of Anaesthesiology LLRM Medical College, jagriti Vihar, Meerut.
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8584998729 |
| Fax |
|
| Email |
akvish92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology, LLRM medical college, SVBP hospital, meerut, UP, India pin code-250004 |
|
|
Primary Sponsor
|
| Name |
Dr Avanish kumar vishwakarma |
| Address |
LLRM Medical College, ground Floor ,roon No-g10, Department Of Anaesthesiology LLRM Medical College,jagriti Vihar Meerut,UP,India,pin code-250004 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Avanish kumar vishwakarma |
Sardar Vallabhbhai patel hospital |
LLRM Medical college,Department of GROUND FLOOR ,ROON NO-G10, beside IT parking,Jagritivihar, MEERUT,UP,INDIA,Pin code-250004
Meerut
UTTAR PRADESH |
8584998729
akvish92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the principal, LLRM medical college, meerutInstitutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: V021||Pedestrian injured in collision with two- or three-wheeled motor vehicle in traffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Levobupivacaine 0.75% total 30 ml drugs will be given , |
Inj Levobupivacaine 0.75% will be given(10 ml each patient) in Adductor canal block single shot injection (frequency once time) in supine slightly abducted position and( 20 ml each patient ) popliteal sciatic nerve block, single shot(frequency once time) in lateral position , drug will be deposited around neural sheath after negative aspiration under USG guidance |
| Comparator Agent |
Inj. Levobupivacaine 0.75% Heavy (in SAB),1.5 ml |
Inj Levobupivacaine heavy 0.75% ( 1.5ml each patient) will be given in Sub arachnoid space at L3-L4 spinal segment in lateral position at mid line of spinous process,in one single shot(frequency once time),effect will be checked assessed. |
| Intervention |
Ultrasound guided block |
Adductor canal block and Popleteal sciatic Block will be performed with the help of USG |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Asa 1&2 Patient ,patients Undergoing Elective Lower Limb Surgeries And Patient With Inform Consent |
|
| ExclusionCriteria |
| Details |
Patient Refusal,infection At Injection Site,coagulopathy,heart Block Patient,peripheral Neuropathy,known Allergy Or Hypersensitivityto Local Anaesthetic Drugs,patient With Peripheral Vascular Disease,patient With Any Containdication To Regional Anaesthesia. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assess The Quality Of Block Either-
Compelete Block
Incomplete Block |
Assess the quality of block at 0 min, 5 min, 10 min, 15 min, 20 min, 25 min, and 30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the Heamodynamic changes, Onset of sensory and motor block, Postoperative analgesia requiring first dose of rescue analgesia and complication if any |
Assess the quality of block at 0 min, 5 min, 10 min, 15 min, 20 min, 25 min, and 30 min |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/07/2024 |
| 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 Yet Recruiting |
| 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
|
This study is a Prospective Randomised Comparative Study of Efficacy of Ultrasound Guided Popliteal Sciatic Nerve & Adductor Canal Block Versus Unilateral Subarachnoid Block as a Sole Anaesthetic Technique for Lower Limb Surgeries
Also we will be assessing the heamodynamic changes, quality and onset of sensory and motor block and complication if any,.during inta operative and post operative.we enrolled 30 patient in each group and using usg sonosite system intervention will be performed. |