| CTRI Number |
CTRI/2025/02/080423 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare 3 different drug combination for post operative analgesia for patients undergoing knee surgeries |
|
Scientific Title of Study
|
A Randomized control Trail Comparing Post operative Analgesic Effect of Dexmeditomidine vs Nalbuphine as an Adjuvant with Ropivacaine in USG Guided Adductor Canal Block in Patients Undergoing Knee 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 |
Dr T Shalini |
| Designation |
Postgraduate ( MD Anaesthesiology) |
| Affiliation |
SRM Medical College and Research Institute |
| Address |
B-BLOCK
2nd floor
Department of anesthesiology SRM Medical college and Research Institute
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
621216
India |
| Phone |
9600826518 |
| Fax |
|
| Email |
shalinithiyagarajan99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Karthik |
| Designation |
Professor of Department of Anaesthesiology |
| Affiliation |
SRM Institute Of Science and Technology |
| Address |
Room no:209, B-BLOCK, 2nd floor, Department of anesthesiology,
SRM Medical college and Research Institute
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Karthik |
| Designation |
Professor of Department of Anaesthesiology |
| Affiliation |
SRM Institute Of Science and Technology |
| Address |
Room no:209, B-BLOCK, 2nd floor, Department of anesthesiology,
SRM Medical college and Research Institute
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884360796 |
| Fax |
|
| Email |
karthikkrishnamoorthy1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| BBLOCK
2nd floor
Department of anesthesiology
SRM Medical college and Research Institute
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
|
|
Primary Sponsor
|
| Name |
SRM MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
B BLOCK
2nd floor
Department of anesthesiology
SRM Medical college and Research Institute Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| 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 |
| Dr K Karthik |
SRM MEDICAL COLLEGE AND RESEARCH INSTITUTE |
B-BLOCK
2nd floor
Department of anesthesiology
SRM Medical college and Research Institute
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU |
9600826518
shalinithiyagarajan99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee- Students |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ropivacaine with nalbuphine |
ultrasound guided adductor canal block with ropivacaine (0.5% 20ml)with nalbuphine(10mg) and post operative pain assessed for the first 24 hours |
| Intervention |
ropivacaine with dexmeditomidine |
ultrasound guided adductor canal nerve block with ropivacaine(0.5% 20ml) with dexmeditomidine(50mcg)and postoperative pain within the first 24 hours is asseseed |
| Comparator Agent |
ultrasound guided adductor canal block with plain ropivacaine |
plain ropivacaine(0.5% 20ml)given and post operative pain assessed for the first 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-65
ASA PS 1-2
All patients undergoing knee surgeries.
Both sexes
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindications to regional nerve block:
Cellulitis / infection at the local site
Coagulopathy
Allergy to local anaesthetic agents
Patients with pre existing nerve injury.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to first rescue analgesia demand. If VAS score more than 3 Inj.paracetamol and if VAS 3-6 Inj. tramadol 100mg in 100ml NS.
|
1st hour,2nd hour,3rd hour,4th hour,5th hour,6th hour,12th hour,18th hour,24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requirement of total analgesic doses in first 24hours.
VAS score for first 24hours
Early ambulation based on TUG TEST.
|
1st hour,2nd hour,3rd hour,4th hour,5th hour,6th hour,12th hour,18th hour,24th hour |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/02/2025 |
| 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="1"
Months="0"
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
|
A total of 120 patients belonging to age group 18 to 65 years , ASA class I and II scheduled for knee procedures will be prospectively studied. In this double-blinded randomized control trial,a total of 120 participants will be allocated into three groups - Randomisation into 3 groups by computer generated randomisation –Group D,Group N,GROUP R. GROUP D- Patients receive Inj. Ropivacaine 0.5% 20ml +Inj. Dexmedetomidine 50mcg/kg.GROUP N- Patients receive Inj. Ropivacaine 0.5% 20ml + Inj. Nalbuphine 10ml.Group R – Patients receive Inj.ropivacaine0.5% plain 20ml +10ml of distilled water.Under ASP, spinal anesthesia given with 0.5% of bupivacaine(H) 3ml @L3-L4 space with Quincke 25g needle to the assigned group.Under ASP, Adductor canal block will be given to the assigned group.Post operative pain will be assessed for the 1st 24 hours.Data collection will be done by observation and measurement of various parameters. |