| CTRI Number |
CTRI/2025/09/095251 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Ropivacaine epidural infusion versus Intravenous Dexmedetomidine infusion for post surgery pain management and vitals of patient in open Urological surgeries |
|
Scientific Title of Study
|
Comparative study of Ropivacaine epidural infusion versus IV Dexmedetomidine infusion for postoperative pain management and hemodynamic stability in open Urological 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 |
Supreet kaur |
| Designation |
Pg resident |
| Affiliation |
Adesh institute of medical science and research. |
| Address |
Department of anaesthesiology and intensive care, adesh institute of medical science and research , bathinda, Punjab, India.
Department of anaesthesiology and intensive care, adesh institute of medical science and research , bathinda, Punjab, India.
Bathinda
PUNJAB
151001
India |
| Phone |
6283520612 |
| Fax |
|
| Email |
Kaursupreet1504@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ankush singla |
| Designation |
Professor |
| Affiliation |
Adesh institute of medical science and research |
| Address |
Department of anaesthesiology and intensive care, adesh institute of medical science and research , bathinda, Punjab, India.
Department of anaesthesiology and intensive care, adesh institute of medical science and research , bathinda, Punjab, India.
Bathinda
PUNJAB
151001
India |
| Phone |
9814367676 |
| Fax |
|
| Email |
ankush.singla54@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Supreet kaur |
| Designation |
Pg resident |
| Affiliation |
Adesh institute of medical science and research |
| Address |
Department of anaesthesiology and intensive care, adesh institute of medical science and research , bathinda, Punjab, India.
Department of anaesthesiology and intensive care, adesh institute of medical science and research , bathinda, Punjab, India.
Bathinda
PUNJAB
151001
India |
| Phone |
6283520612 |
| Fax |
|
| Email |
Kaursupreet1504@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh institute of medical sciences and research,Bathinda,Punjab,151001 India |
|
|
Primary Sponsor
|
| Name |
Supreet kaur |
| Address |
Adesh institute of medical sciences and research,Bathinda,Punjab |
| 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 Supreet kaur |
Adesh institute of medical sciences and research, bathinda, punjab |
Department of Anaesthisiology and Critical Care,in collaboration with the department of urology
Bathinda
PUNJAB |
6283520612
Kaursupreet1504@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee,Adesh University,Bathinda |
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 |
| Comparator Agent |
dexmedetomidine and ropivacaine |
Comparision of epidural infusion of 0.2% ropivacaine at a rate of 6-8ml/hour for 48 hours and intravenous infusion of dexmedetomidine 0.5microgram/kg/hour for 48 hours for pain management in open urological surgeries |
| Intervention |
epidural infusion versus intravenous infusion |
Comparision of analgesic and hemodynamic properties |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA physical status 1-3
2)Scheduled for elective open urological surgeries(nephrectomy,pyeloplasty,radical nephrectomy,radical cystectomy)
3)Willing to give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with known allergy to local anesthetics or dexmedetomidine
2. Contraindications to epidural catheter placement (coagulopathy, infection at insertion site, severe spinal deformity)
3. Severe cardiovascular disease (uncontrolled hypertension, heart block, cardiac failure)
4. Severe hepatic or renal impairment
5. History of chronic pain requiring regular analgesics
6. Psychological disorders that may affect pain assessment
7. Pregnancy or lactation9
8. Unable to comprehend visual analog scale (VAS)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • Postoperative pain scores using VAS . |
baseline
2hours
4hours
6hours
12hours
24hours
36hours
48hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to first rescue analgesic requirement.
2. Total consumption of rescue analgesics in the first 48 hours postoperatively.
3. Hemodynamic parameters (heart rate, systolic blood pressure, diastolic blood pressure) at specified intervals.
4. Sedation scores using the Ramsay Sedation Scale.
5. Incidence of adverse effects (hypotension, bradycardia, respiratory depression, nausea, vomiting, pruritus).
6. Patient satisfaction with pain management (assessed on a 5-point Likert scale: 1 = very dissatisfied, 2 = dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = satisfied, 5 = very satisfied).
|
baseline
2 hours
4 hours
6 hours
12 hours
24 hours
36 hours
48 hours |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="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
|
Effective postoperative pain management is essential for early recovery, reduced morbidity and patient satisfaction. Ropivacaine a long acting amide local anesthetic , administered via epidural infusion ,provides effective segmental analgesia, reduced systemic opioid requirement. on the other hand , Dexmedetomidine , a highly selective alpha 2- adrenergic agonist ,when given intravenously, offers analgesia and sedation thereby maintaining hemodynamic stability with opioid sparing effects. This comparative study aims to evaluate the efficacy and safety of continuous epidural infusion of Ropivacaine verses intravenous infusion of Dexmedetomidine in patients undergoing open urological surgeries. The primary objective includes assessment of post operative pain scores and hemodynamic parameters, while secondary outcomes will focus on sedation levels and requirement of rescue analgesic. |