| CTRI Number |
CTRI/2026/02/104716 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare different medicines used for nerve block to reduce pain after knee replacement surgery |
|
Scientific Title of Study
|
Comparative study of
Ropivacaine alone
versus Ropivacaine
combined with
Dexmedetomidine and
Dexamethasone in
ultrasound Guided
Adductor canal Block
for Postoperative
Analgesia in unilateral
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 |
Nikita Rawat |
| Designation |
PG student |
| Affiliation |
Medanta the medicity |
| Address |
Medanta the medicine gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
8979495845 |
| Fax |
|
| Email |
nikitarawat201297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikita Rawat |
| Designation |
PG student |
| Affiliation |
Medanta the medicity |
| Address |
Medanta the medicity
Gurgaon
HARYANA
122001
India |
| Phone |
8979495845 |
| Fax |
|
| Email |
nikitarawat201297@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nikita Rawat |
| Designation |
PG student |
| Affiliation |
Medanta the medicity |
| Address |
Medanta the medicity gurugram
Gurgaon
HARYANA
122001
India |
| Phone |
8979495845 |
| Fax |
|
| Email |
nikitarawat201297@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Medanta The Medicity |
| Address |
Sector 38, Gurugram, Haryana 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Nikita Rawat |
Orthopaedic deparment |
Medanta The Medicity
Gurgaon
HARYANA |
8979495845
nikitarawat201297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Commeeti |
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 |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-75 years
American Society of Anaesthesiologists (ASA) physical status I or II
Scheduled for unilateral Total Knee Arthroplasty (TKA)
Patients providing voluntary written informed consent.
|
|
| ExclusionCriteria |
| Details |
Allergy to any study drugs (local anaesthetics, Dexamethasone, Dexmedetomidine).
Chronic opioid use (defined as regular opioid use for more than 7 consecutive days within the last 3 months).
Pregnancy or lactation.
Pre-existing neurological or psychiatric illness that could interfere with pain assessment or cooperation.
Inability to understand or cooperate with the study protocol or pain assessment scales.
Contraindications to Adductor Canal Block (e.g., local infection at the injection site, coagulopathy).
Patients undergoing bilateral TKA.
Patients with pre-existing motor weakness or neuropathy of the lower limb.
Patients with severe cardiac or respiratory comorbidities (ASA III and above).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia (time to first rescue analgesic requirement) between the subjects receiving 0.2% Ropivacaine alone and the subjects receiving 0.2% Ropivacaine with Dexmedetomidine (25 mcg) and Dexamethasone (6 mg) as adjuvants in Adductor Canal Block for TKA. |
Assessed 24 hour postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare opioid consumption (total intravenous fentanyl equivalent), Visual Analog Scale (VAS) pain scores at various time points (0, 2, 4, 8, 16, 24 hours), & Sedation scores between the two groups.
2. To assess haemodynamic parameters (Heart Rate, Blood Pressure), & the occurrence of adverse effects (e.g., nausea, vomiting, dizziness, bradycardia, hypotension) in both groups.
3. To compare the early ambulation (by measuring number of steps walked on postoperative day 1 after 24 hour) between the two groups.
|
Assessed 24 hour postoperatively |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
10/03/2026 |
| 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="1"
Months="0"
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
|
This study is a prospective randomized comparative study to evaluate the efficacy of 0.2 percent ropivacaine alone versus 0.2 percent ropivacaine combined with dexamethasone and dexmedetomidine in ultrasound guided adductor canal block for postoperative analgesia in patients undergoing unilateral total knee replacement surgery. The primary objective is to compare duration of postoperative analgesia between the two groups. Secondary objectives include comparison of postoperative pain scores, total rescue analgesic consumption in 24 hours, time to first rescue analgesia, and incidence of adverse effects. Patients will be randomly allocated into two groups. Group R will receive 0.2 percent ropivacaine and Group RD will receive 0.2 percent ropivacaine with dexamethasone and dexmedetomidine. Outcomes will be assessed during the first 24 hours postoperatively. |