| CTRI Number |
CTRI/2021/11/038020 [Registered on: 12/11/2021] Trial Registered Prospectively |
| Last Modified On: |
10/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF EPIDURAL(OUTSIDE SPINAL CORD)DEXAMETHASONE (STEROID)AND EPIDURAL MORPHINE(OPIOID)FOR POST OPERATIVE PAIN RELIEF IN TOTAL ABDOMINAL HYSTERECTOMY(REMOVAL OF UTERUS) |
|
Scientific Title of Study
|
COMPARISON OF EPIDURAL DEXAMETHASONE AND EPIDURAL MORPHINE FOR POST OPERATIVE ANALGESIA IN TOTAL ABDOMINAL HYSTERECTOMY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYANKA CHANDRAN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
| Address |
ROOM NO:8,FIRST FLOOR,VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS,SALEM
ROOM NO:8,FIRST FLOOR,VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS,SEERAGAPADI SANKARI MAIN ROAD NH47 SALEM 636308 TAMILNADU
Salem
TAMIL NADU
636308
India |
| Phone |
9789092597 |
| Fax |
|
| Email |
CPRIYANKA55@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
VIGNESHWARAN S |
| Designation |
ASSISTANT PROFFESSOR |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
| Address |
ROOM NO:8,FIRST FLOOR,VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS,SALEM
ROOM NO:8,FIRST FLOOR,VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS,SEERAGAPADI SANKARI MAIN ROAD NH47 SALEM 636308 TAMILNADU
Salem
TAMIL NADU
636308
India |
| Phone |
9789092597 |
| Fax |
|
| Email |
DRVIGNESHWARANS@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANKA CHANDRAN |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
| Address |
ROOM NO:8,FIRST FLOOR,VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS,SALEM
ROOM NO:8,FIRST FLOOR,VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS,SEERAGAPADI SANKARI MAIN ROAD NH47 SALEM 636308 TAMILNADU
Salem
TAMIL NADU
636308
India |
| Phone |
9789092597 |
| Fax |
|
| Email |
CPRIYANKA55@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
|
|
Primary Sponsor
|
| Name |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
| Address |
SEERAGAPADI,SALEM |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| VIGNESHWARAN |
ASSISTANT PROFESSOR, DEPARTMENT OF ANESTHESIA
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRIYANKA CHANDRAN |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
ROOM NO:8,FIRST FLOOR,OT COMPLEX,DEPARTMENT OF ANESTHESIA, VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS SEERAGAPADI
Salem
TAMIL NADU |
9789092597
CPRIYANKA55@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Kirupananda Variyar medical college & hospitals |
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 |
EPIDURAL DEXAMETHASONE |
8MG DEXAMETHASONE (2 ML) AS AN ADDITIVE TO 8ML 0.5% BUPIVACAINE EPIDURALLY IN ONE GROUP (ONE YEAR STUDY) |
| Comparator Agent |
EPIDURAL MORPHINE |
4 MG MORPHINE IN 2 ML NORMAL SALINE AS AN ADDITIVE TO 8ML 0.5% BUPIVACAINE EPIDURALLY IN THE OTHER GROUP(ONE YEAR STUDY) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 AND 2 PATIENTS UNDERGOING TOTAL ABDOMINAL HYSTERECTOMY UNDER EPIDURAL ANESTHESIA |
|
| ExclusionCriteria |
| Details |
PATIENTS WHO ARE NOT WILLING FOR TRIAL, ALLERGIC TO DRUGS USED IN THE TRIAL, ASA GRADE 3 & 4, PATIENTS WHO ARE CONTRAINDICATED FOR EPIDURAL ANESTHESIA, PATIENTS REQUIRING GENERAL ANESTHESIA |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO DETERMINE THE POSTOPERATIVE ANALGESIC EFFICACY OF EPIDURAL DEXAMETHASONE AND EPIDURAL MORHINE AS ADDITIVES TO BUPIVACAINE USING VISUAL ANALOG SCALE |
POST OPERATIVE ANALGESIA WILL BE ASSESSED UPTO 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE ADVERSE EFFECTS OF EPIDURAL DEXAMETHASONE AND MORPHINE |
ADVERSE EFFECTS WILL BE MONITORED FOR 24 HOURS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/11/2021 |
| 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
|
no publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 patients undergoing total abdominal hysterectomy under epidural anaeshesia will be recruited for the study. They will be randomized into two groups. One group will receive 4 mg morphine in 2 ml normal saline as an additive to 8 ml 0.5 % bupivacaine and the other group will receive 8 mg dexamethasone as an additive to 8 ml 0.5 % bupivacaine. The duration of postoperative analgesia will be assessed using visual analogue scale and the time of administration of first rescue analgesic will be noted and compared in both groups. Adverse effects will also be monitored. |