| CTRI Number |
CTRI/2025/08/093839 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing pain relief from intravenous vs nerve block dexmedetomidine with bupivacaine in ultrasound guided adductor canal block for knee replacement surgery |
|
Scientific Title of Study
|
A randomized comparative study to evaluate the analgesic effect of intravenous versus perineural dexmedetomidine as an adjuvant to bupivacaine in ultrasound-guided adductor canal block in patients undergoing total knee arthroplasty.
|
| 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 Harsimrat Kaur |
| Designation |
junior resident |
| Affiliation |
Sawai Maan Singh Medical college |
| Address |
Anesthesia department
Sawai Maan Singh medical college
Jaipur
Rajasthan
India
Jaipur
RAJASTHAN
302004
India |
| Phone |
7710655001 |
| Fax |
|
| Email |
harsimrat1310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anaesthesiology SMS Medical College and Hospital
Jaipur Rajasthan 302004 India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Senior professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department of Anaesthesiology SMS Medical College and Hospital
Jaipur Rajasthan 302004 India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sawai maan medical college
Jaipur
Rajasthan
Pincode 302004
India
rajasthan |
|
|
Primary Sponsor
|
| Name |
Sawai Maan Singh medical college |
| Address |
Jawahar Lal Nehru Marg
Jaipur
Rajasthan
302004 |
| 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 Mamta Khandelwal |
SMS Medical College and Hospital |
Department of Anaesthesiology SMS Medical College and Hospital Jaipur Rajasthan 302004 Jaipur
Jaipur
RAJASTHAN |
9929338174
drmamtakhandelwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of intravenous DEXMEDETOMIDINE for duration of one year |
A randomized comparative study to evaluate the analgesic effect of intravenous dexmedetomidine as an adjuvant to bupivacaine in ultrasound-guided adductor canal block in patients undergoing total knee arthroplasty duration of one year
|
| Comparator Agent |
EFFECT OF PERINEURAL DEXMEDETOMIDINE as an adjuvant to bupivacaine duration of one year |
A randomized comparative study to evaluate the analgesic effect of perineural dexmedetomidine as an adjuvant to bupivacaine in ultrasound-guided adductor canal block in patients undergoing total knee arthroplasty duration of one year .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Undergoing total knee replacement
Informed written conscent
American society of anesthesiologists grade 1,2 and 3 |
|
| ExclusionCriteria |
| Details |
Psychiatric illness
Peripheral sensorineural deficit
Allergic to study drugs
Infection at site of block
Compartment syndrome |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| no significant difference in onset of sensory block between IV and perineural administration of dexmedetomidine as an adjuvant to bupivacaine in USG guided adductor canal block in patients undergoing total knee arthroplasty. |
5min ,10mins,15 mins,20 mins postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/09/2025 |
| 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
|
The purpose of study is to compare which route between IV and perineural administration of Dexmedetomidine as an adjuvant to bupivacaine in USG guided adductor canal block is better for the onset of sensory block and analgesic effect.
We are doing this study because Total Knee Arthroplasty is associated with severe post operative pain and Adductor Canal Block is primarily a sensory block. Dexmedetomidine is a highly selective alpha-2 adrenergic agonist that is effectively used as a safe analgesic adjuvant. By finding which route (IV vs Perineural ) is better we can use dexmedetomidine as an adjuvant by that route safely. |