| CTRI Number |
CTRI/2026/02/103465 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| 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
|
Comparing Low vs. High Doses of a Safe Sedative Added to Numbness Medicine for Knee Surgery Pain Relief After Total Knee Replacement |
|
Scientific Title of Study
|
Comparison of two different doses of dexmedetomidine as an adjuvant to levo-bupivacaine in ultrasound guided adductor canal block for postoperative analgesia in total knee replacement-A Prospective randomized double blinded Study |
| 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 Kanagalla Mary Shalini |
| Designation |
Junior resident |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Room number 3,Speciality block ot,3rd floor ,Department of Anaesthesia ,Nizams institute of Medical Sciences , Punjagutta,Hyderabad
Hyderabad
TELANGANA
500082
India |
| Phone |
9032808553 |
| Fax |
|
| Email |
maryshalini2801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monu Yadav |
| Designation |
Professor |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room no 1 :1st floor MOT, Department of anaesthesia, Outpatient building,Nizams Institute of Medical Sciences,punjagutta,Hyderabad-500082,India
Hyderabad
TELANGANA
500082
India |
| Phone |
9490213460 |
| Fax |
|
| Email |
monubalbir@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monu Yadav |
| Designation |
Professor |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room no 1 :1st floor MOT, Department of anaesthesia, Outpatient building,Nizams Institute of Medical Sciences,punjagutta,Hyderabad-500082,India
Hyderabad
TELANGANA
500082
India |
| Phone |
9490213460 |
| Fax |
|
| Email |
monubalbir@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Nizams Institute Of Medical Sciences,Hyderabad-500082,India |
|
|
Primary Sponsor
|
| Name |
Kanagalla Mary Shalini |
| Address |
Room no 3,Speciality block OT,3rd floor ,Department of Anaesthesia, Nizams institute of Medical Sciences,Punjagutta ,Hyderabad-500082 |
| 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 Mary Shalini |
Nizams Institute of Medical Sciences |
Main Operation Theatre
Old Block
Nizams Institute of Medical Sciences, Hyderabad
Hyderabad
TELANGANA |
90328 08553
maryshalini2801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nizams Institute 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ultrasound guided adductor canal block with levobupivacaine and dexmedetomidine |
Ultrasound guided adductor canal block performed at the end of surgery using 15ml of 0.25 % levobupivacaine with dexmedetomidine 0.5mcg/kg
route of administration: perineural injection
Frequency : single dose
Total duration of intervention:single administration at the end of surgery |
| Comparator Agent |
Ultrasound-guided adductor canal block with levobupivacine and dexmedetomidine |
Ultrasound guided adductor canal block performed at the end of surgery using 15ml of 0.25% levobupivacaine with dexmedetomidine 1mcg/kg
Route :perineural injection
Frequency :single dose
total duration of intervention: single administration at the end of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective TKR
Patient’s belonging to American society of Anaesthesiologist class 1 and 2 |
|
| ExclusionCriteria |
| Details |
Patient who does not give consent for the study
Patient with any active infection at the site of administration of block
Emergency surgeries
Patients with local anesthetic allergy
Presence of any pre-existing neuropathies
Anticoagulation or bleeding disorders
Patient with beta blockers
Patient with cardiac diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of analgesia provided by the two different doses of dexmedetomidine |
24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To record and compare the total amount and timing of rescue analgesia administered within 24hours.
2.To evaluate any side effects
3.Comparision of VAS score
4.To see Ramsay sedation score |
24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/02/2026 |
| 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="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 prospective randomized double blinded study aims to compare two different doses of dexmedetomidine 0.5 microgram per kilogram and 1 microgram per kilogram as an adjuvant to 0.25 percent levobupivacaine in ultrasound guided adductor canal block for postoperative analgesia in patients undergoing total knee replacement under spinal anesthesia .Fifty ASA one and two patients will be randomized into two groups. The primary outcome is duration of postoperative analgesia. Secondary outcomes include visual analogue scale scores ,total rescue analgesic consumption, sedation levels and hemodynamic adverse effects. The study seeks to identify the optimal dexmedetomidine dose that provides superior analgesia with minimal side effects. |