| CTRI Number |
CTRI/2021/11/038165 [Registered on: 22/11/2021] Trial Registered Prospectively |
| Last Modified On: |
17/11/2021 |
| 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 LEVOBUPIVACAINE AND ROPIVACAINE GIVEN FOR PAIN RELIEF IN KNEE SURGERY PATIENTS |
|
Scientific Title of Study
|
Comparison of Levobupivacaine with Ropivacaine in adductor canal block for post operative analgesia in arthroscopic anterior cruciate ligament reconstruction ; a prospective,randomised double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
kotana siva rama krishna |
| Designation |
DNB first year resident |
| Affiliation |
DR B L KAPUR MEMORIAL HOSPITAL |
| Address |
DR B L KAPUR MEMORIAL HOSPITAL
New Delhi
DELHI
110005
India |
| Phone |
9490669650 |
| Fax |
|
| Email |
srkkotanambbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHETAN SARAYA |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
delhi medical council |
| Address |
DR B L KAPUR MEMORIAL HOSPITAL
Central
DELHI
110005
India |
| Phone |
9871531845 |
| Fax |
|
| Email |
chetansaraya@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kotana siva rama krishna |
| Designation |
DNB first year resident |
| Affiliation |
DR B L KAPUR MEMORIAL HOSPITAL |
| Address |
DR B L KAPUR MEMORIAL HOSPITAL
DELHI
110005
India |
| Phone |
9490669650 |
| Fax |
|
| Email |
srkkotanambbs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B l kapur memorial hospital, pusa road, new delhi 110005, |
|
|
Primary Sponsor
|
| Name |
Dr siva rama krishna |
| Address |
Dr B L Kapur memorial hospital,pusa road , new delhi. |
| Type of Sponsor |
Other [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 Kotana Siva Rama Krishna |
DR B L KAPUR MEMORIAL HOSPITAL |
Department of anesthesiology and pain management, 2nd floor, pusaroad ,new delhi 110005.
Central
DELHI |
9490669650
srkkotanambbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr B L kapur memorial hospital ethics committee |
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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ADDUCTOR CANAL BLOCK |
ADDUCTOR CANAL BLOCK IN POST OPERATIVE ACL RECONSTRUCTION PATIENTS |
| Comparator Agent |
ADDUCTOR CANAL BLOCK WITH
20ml 0.25%LEVOBUPIVACAINE in group L 20ml 0.375% ROPIVACAINE in group R given single dose in adductor canal |
LEVOBUPIVACAINE, ROPIVACAINE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
elective acl repair surgeries under subarachnoid block and giving consent for post operative adductor canal block.
american society of anaesthesiologists physical health status (ASA grade 1 and 2 )
|
|
| ExclusionCriteria |
| Details |
ASA 3,4 and 5
allergy to study drugs.
pregnant females
morbidly obese patients with BMI >35
with height <160cm and >180cm. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine duration of analgesia and total rescue analgesic requirement over 24 hrs. |
0,1st,2nd,4th,8th and 24 th hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
patient satisfaction score
hemodynamic stability
early mobilization |
0,1st,2nd,4th,8th and 24 th hours. |
|
|
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)
|
01/12/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Local anaesthetics agents are selected for peripheral nerve block for prolonged post operative pain relief with minimum motor blockade. Therefore we wish to conduct this randomized prospective trail to compare effectiveness,duration,and quality of sensory block of levobupivacaine and ropivacaine in appropriate concentrations for post operative analgesia when used for adductor canal block ,performed with ultrasound guidance in patients undergoing arthroscopic anterior cruciate ligament reconstruction surgery. |