| CTRI Number |
CTRI/2025/11/097564 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Postop Analgesia using USG guided Adductor canal block with Ropivacaine alone versus Ropivacaine with Fentanyl in knee and below knee surgeries;A Randomised Controlled Trial |
|
Scientific Title of Study
|
Comparison of postoperative analgesia using Ultrasound guided Adductor canal block with Ropivacaine alone versus Ropivacaine with fentanyl in knee and below knee surgeries; A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BONGANI MANOJ KUMAR |
| Designation |
DNB POST DIPLOMA RESIDENT |
| Affiliation |
Kalpana chawla medical college,karnal |
| Address |
DNB POST DIPLOMA RESIDENT
DEPARTMENT OF ANAESTHESIOLOGY
KALPANA CHAWLA MEDICAL COLLEGE
KARNAL,HARYANA
Karnal
HARYANA
132001
India |
| Phone |
7702109776 |
| Fax |
|
| Email |
MANOJKUMARBONGANI.28@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KIRAN SHARMA |
| Designation |
PROFESSOR |
| Affiliation |
Kalpana chawla medical college,karnal |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KALPANA CHAWLA MEDICAL COLLEGE
KARNAL,HARYANA
Karnal
HARYANA
132001
India |
| Phone |
9812712477 |
| Fax |
|
| Email |
KIRANSHARMA29@REDDIFMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
BONGANI MANOJ KUMAR |
| Designation |
DNB POST DIPLOMA RESIDENT |
| Affiliation |
Kalpana chawla medical college,karnal |
| Address |
DEPARTMENT OF ANAESTHSIOLOGY
KALPANA CHAWLA MEDICAL COLLEGE
KARNAL,HARYANA
Karnal
HARYANA
132001
India |
| Phone |
7702109776 |
| Fax |
|
| Email |
MANOJKUMARBONGANI.28@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| KALPANA CHAWLA MEDICAL COLLEGE
KARNAL,HARYANA-132001 |
|
|
Primary Sponsor
|
| Name |
KALPANA CHAWLA MEDICAL COLLEGE |
| Address |
KARNAL,HARYANA-132001 |
| Type of Sponsor |
Government 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 BONGANI MANOJ KUMAR |
Kalpana chawla medical college |
Dept of Anaesthesiology,kalpana chawla medical college,Model town,karnal,Haryana-132001
Karnal
HARYANA |
7702109776
MANOJKUMARBONGANI.28@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
adductor canal block |
adductor canal block with ropivacaine alone in one group and ropivacaine with fentanyl in another group |
| Intervention |
Adductor canal block |
Adductor canal block with usg guided in knee and below knee surgeries for 9months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-III
BMI 18-35 Kg/m2
sechduled knee and below knee surgeries |
|
| ExclusionCriteria |
| Details |
ASA III
Pregnants
Patients not willing for study
Children below 18yrs
Patients on pregabalin
history of neuropathy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the time duration and quality of postoperative analgesic effect |
AT 4hrs,8hrs,12hrs and 24hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare incidence of adverse effects in both the groups |
9 months |
| to compare rescue analgesics in both the groups |
9 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/11/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Patients are divided into 2 groups. 1 group is given Inj Ropivacaine 15ml and 1 group is given Inj Ropivacaine and fentanyl (14ml+1ml) . both the groups assessed postoperatively for 24 hrs. Combination with ropivacaine with fentanyl in lower limb surgeries. This study aims to cover this combination in knee and below knee surgeries. |