| CTRI Number |
CTRI/2023/10/059123 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| 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
|
A study to compare two medicines to decrease pain after surgery. |
|
Scientific Title of Study
|
Comparative study of epidural Bupivacaine with Dexmedetomidine vs Bupivacaine with Fentanyl on intraoperative hemodynamics and postoperative pain relief in gynaecological oncology surgeries. |
| Trial Acronym |
. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.S.Monisha |
| Designation |
MBBS,DNB ANAESTHESIA post graduate |
| Affiliation |
SRI RAMAKRISHNA HOSPITAL |
| Address |
69/1 CHERAN NAGAR 2 ,
METTUPALAYAM
COIMBATORE -641301
Department of anesthesiology,
A block second floor OT complex,
395, Sarojini Naidu Rd, Siddhapudur, New Siddhapudur, Coimbatore, Tamil Nadu 641044
Coimbatore
TAMIL NADU
641301
India |
| Phone |
9843318199 |
| Fax |
|
| Email |
sukumarmonisha96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Ramya parameshwari |
| Designation |
MBBS,DA,DNB ANESTHESIA consultant anesthesiologist |
| Affiliation |
SRI RAMAKRISHNA HOSPITAL |
| Address |
163/1 ,palaniandavar koil Street,
Ganapathy
Coimbatore.
Department of anesthesiology,
A block second floor OT complex,
395, Sarojini Naidu Rd, Siddhapudur, New Siddhapudur, Coimbatore, Tamil Nadu 641044
Coimbatore
TAMIL NADU
641006
India |
| Phone |
9566526296 |
| Fax |
|
| Email |
arjunanramya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.SMonisha |
| Designation |
MBBS,DNB ANAESTHESIA post graduate |
| Affiliation |
SRI RAMAKRISHNA HOSPITAL |
| Address |
69/1 CHERAN NAGAR 2 ,
METTUPALAYAM
COIMBATORE -641301
Department of anesthesiology
A block second floor OT complex,
395, Sarojini Naidu Rd, Siddhapudur, New Siddhapudur, Coimbatore, Tamil Nadu 641044
Coimbatore
TAMIL NADU
641301
India |
| Phone |
9843318199 |
| Fax |
|
| Email |
sukumarmonisha96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna hospital,
Department of anesthesiology,
A block second floor OT complex,
395, sarojini Naidu Rd,
Siddhapudur, New Siddhapudur, Coimbatore, Tamil Nadu 641044 |
|
|
Primary Sponsor
|
| Name |
SRI RAMAKRISHNA HOSPITAL |
| Address |
395, Sarojini Naidu Rd, Siddhapudur, New Siddhapudur, Coimbatore, Tamil Nadu 641044
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SMonisha |
Sri Ramakrishna hospital |
Department of anesthesiology A block second floor OT complex 395, Sarojini Naidu Rd, Siddhapudur, New Siddhapudur, Coimbatore, Tamil Nadu 641044
Coimbatore
TAMIL NADU |
9843318199
sukumarmonisha96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna hospital 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 |
| Comparator Agent |
40 patients given 0.08 % Bupivacaine given epidurally via epidural infusion pump at 6ml/hr for 24 hours with 0.3mcg/ml dexmedetomidine epidurally via epidural infusion pump at 6ml/hr for 24 hours |
Epidurally administered bupivacaine with dexmeditomidine for postoperative pain relief |
| Comparator Agent |
40 patients given 0.08% Bupivacaine given epidurally via epidural infusion pump at 6ml/hr for 24 hours with
1 mcg/ml fentanyl given epidurally via epidural infusion pump at 6ml/hr for 24 hours |
Epidurally administered bupivacaine with fentanyl for postoperative pain relief |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1 and 2 patients.
Patients with age group of 18 to 65years. • Patients undergoing elective gynaecology oncology surgeries.
Patients who provide consent for surgery. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
ASA >3
Patients allergic to study drug.
Patients with significant coagulopathy.
Patients with absolute contraindication for regional anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the time for first rescue analgesic requirement in patients receiving epidural bupivacaine with dexmedetomidine vs epidural bupivacaine with fentanyl in gynaecological oncology surgeries. |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of hypotension, bradycardia, pruritus in patients receiving epidural bupivacaine with dexmedetomidine vs epidural bupivacaine with fentanyl in gynaecological oncology surgeries. |
Six months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/11/2023 |
| 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)
|
Open to Recruitment |
| 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
|
Comparative study to monitor the intraoperative hemodynamics and post operative pain relief in patients receiving epidural bupivacaine with dexmeditomidine and epidural bupivacaine with fentanyl in gynecological oncology surgeries. |