| CTRI Number |
CTRI/2025/08/092651 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical comparative bupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine as an adjuvant in thoracic epidural in abdominal surgeries |
|
Scientific Title of Study
|
A clinical comparative study of bupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine as an adjuvant in thoracic epidural for patients undergoing abdominal surgeries for post operative pain management |
| 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 Pramod Chand |
| Designation |
Associate Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anesthesia,LLRM Medical College,Meerut,
Uttar Pradesh
250004
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9557040620 |
| Fax |
|
| Email |
pcllrm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Chand |
| Designation |
Associate Professor |
| Affiliation |
LLRM Medical College |
| Address |
Department of Anesthesia,LLRM Medical College,Meerut,
Uttar Pradesh
250004
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9557040620 |
| Fax |
|
| Email |
pcllrm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Agarwal |
| Designation |
PG scholar |
| Affiliation |
LLRM Medical College, Meerut |
| Address |
Department of Anesthesia ,
LLRM Medical College,
Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8273135806 |
| Fax |
|
| Email |
agarwalricha8191@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia,LLRM MEDICAL COLLEGE Meerut |
|
|
Primary Sponsor
|
| Name |
Dr Richa Agarwal |
| Address |
LLRM MEDICAL COLLEGE,MEERUT |
| 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 Richa Agarwal |
LLRM MEDICAL COLLEGE |
Department of ANAESTHESIA , LLRM MEDICAL COLLEGE
Meerut
UTTAR PRADESH |
8273135806
agarwalricha8191@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,LLRM Medical College,Meerut |
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 |
Bupivacaine with Dexmedetomidine |
Inj Bupivacaine 0.5% 20 ml with Inj Dexmedetomidine 1mcg/kg via epidural route |
| Intervention |
Bupivacaine with Dexmedetomidine |
Inj Bupivacaine 0.5% 20 ml with Inj Dexmedetomidine 1 mcg/kg via epidural route |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 & 2 patients |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. Age less than 25 years and more than 60 years.
2. Unwilling patients not giving consent for operation.
3. ASA physical status class III or more.
4. Patients having known hypersensitivity to amide local anaesthetics and Dexmedetomidine.
5. Patients displaying sign and symptoms of systemic infection.
6.Patients having local infection in thoracic spinal region.
7. Patients with pre-existing Diabetes Mellitus, Hypertension, Ischaemic Heart Disease, COPD or any other major systemic illness.
8. Pre-existing CNS disorder-Epilepsy and raised intracranial tension.
9. Pre-existing respiratory disorder-COPD, Asthma, Chronic Bronchitis.
10. Severe renal, hepatic, cardiological, haematological, metabolic disorder.
11. Cardiovascular malformation.
12. Bleeding diathesis or coagulopathy.
13. Spinal deformity.
14. Patients on anticoagulant or antiplatelet therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia with duration of analgesia |
From the time of insertion of epidural and drug given till the time patient starts complaining pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="2"
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
|
A CLINICAL COMPARATIVE STUDY OF BUPIVACAINE WITH DEXMEDETOMIDINE AND ROPIVACAINE WITH DEXMEDETOMIDINE AS AN ADJUVANT IN THORACIC EPIDURAL FOR PATIENTS UNDERGOING ABDOMINAL SURGERIES FOR POST OPERATIVE PAIN MANAGEMENT. PRIMARY OBJECTIVE: To compare the efficacy and safety profile of ropivacaine 0.75% 20 ml and bupivacaine 0.5% 20 ml with dexmedetomidine 1 mcg/kg given via epidural route in the patients planned for abdominal surgery. SECONDARY OBJECTIVE : 1. Hemodynamic alteration 2. Intraoperative complications 3.Postoperative complications 4. Duration of analgesia |