| CTRI Number |
CTRI/2021/08/035440 [Registered on: 05/08/2021] Trial Registered Prospectively |
| Last Modified On: |
12/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision between two groups of medicines for post-operative pain management for lower abdominal surgeries |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF EPIDURAL ROPIVACAINE AND ROPIVACAINE WITH DEXMEDITOMIDINE FOR POSTOPERATIVE ANALGESIA IN LOWER ABDOMINAL SURGERIES IN TERTIARY CARE HOSPITAL, CHENGALPATTU DISTRICT-
A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sai Teja Mathi |
| Designation |
MD Anaesthesia |
| Affiliation |
Shri sathya sai medical College and research institute |
| Address |
Departmemt of Anaesthesiology,Shri sathya sai medical college
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7729090130 |
| Fax |
|
| Email |
stmsaiteja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSVijay Narayanan |
| Designation |
MD Anaesthesia |
| Affiliation |
Shri sathya sai medical College and research institute |
| Address |
Department of Anaesthesiology,Shri sathya sai medical college, Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9444877188 |
| Fax |
|
| Email |
dr.vijay@live.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sai Teja Mathi |
| Designation |
MD Anaesthesia |
| Affiliation |
Shri sathya sai medical College and research institute |
| Address |
Department of Anaesthesiology,Shri sathya sai medical college , Ammapettai
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
7729090130 |
| Fax |
|
| Email |
stmsaiteja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai medical College and research institute, Ammapettai, Chengalpattu district |
|
|
Primary Sponsor
|
| Name |
Dr Mathi Saiteja |
| Address |
Department of Anesthesiology, Shri Sathya Sai medical college and research institution, Ammapettai. |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Mathi Saiteja |
Shri sathya sai medical college and RI |
Department of Anesthesiology,Shri sathya sai medical college and RI, ammapettai, nellikuppam post, kancheepuram district. 603108
Kancheepuram
TAMIL NADU |
7729090130
stmsaiteja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri sathya sai medical college and RI ethical committee |
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 |
| Intervention |
Dexmeditomidine |
Dexmeditomidine 50micrograms is given diluting it to 1cc with distilled water along with Ropivacaine 20cc epidurally after placing the epidural catheterat the starting of the surgery intraoperatively
|
| Comparator Agent |
Dexmeditomidine with ropivacaine |
To compare the analgesic effects of the study drug dexmeditomidine when combined with ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient aged between 20-60 years of both sex
2. Patients belonging to ASA class 1 and 2 posted for elective lower abdominal surgeries.
3. Weight >50kgs.
4. Height 150-180cms.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal for regional anesthesia.
2. Pregnancy and lactation.
3. Patient posted for emergency surgeries.
4. Obese patient with BMI >30.
5. Patients having
a) Raised intra cranial pressure
b) Severe hypovolemia
c) Bleeding coagulopathy
d) Local infections
e) Uncontrolled hypertension/ diabetes mellitus
f) Neurological disorders and deformities of spine
g) Cardiac diseases, Hepatic diseases
h) Allergic to local anesthetic and Dexmedetomidine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic effect of the study drugs and control used in the post operative period |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic state of the study population in the post operative pe |
18 months |
|
|
Target Sample Size
|
Total Sample Size="121"
Sample Size from India="121"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="122" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/08/2021 |
| Date of Study Completion (India) |
23/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To study the synergistic effect of DEXMEDITOMIDINE to ROPIVACAINE 0.5% in epidural anesthesia as post operative analgesia for lower abdominal surgeries. |