| CTRI Number |
CTRI/2022/12/048286 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
19/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
THE ADVANTAGE OF FENTANYL PATCH FOR PAIN RELIEF IN CESAREAN SECTION |
|
Scientific Title of Study
|
EVALUATION OF EFFICACY OF FENTANYL PATCH IN AN ADDITION TO TAP BLOCK IN
POSTOPERATIVE ANALGESIA FOR PATIENTS UNDERGOING LSCS UNDER SPINAL
ANAESTHESIA. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR V Ezhilrajan |
| Designation |
professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
department of anaesthesia
Aarupadai veedu medical and hospital
Kirumampakkam
PUDUCHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9843030074 |
| Fax |
|
| Email |
ezhilrajan96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR E Shanmugavalli |
| Designation |
Associate professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
no 66 PL Suga villa first floor
sindhu street
mangalakshmi nagar
shanmugapuram
puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR E Shanmugavalli |
| Designation |
Associate professor |
| Affiliation |
Aarupadai veedu medical college and hospital |
| Address |
no 66 PL Suga villa first floor
sindhu street
mangalakshmi nagar
shanmugapuram
puducherry
Pondicherry
PONDICHERRY
605009
India |
| Phone |
9940882722 |
| Fax |
|
| Email |
vallijegan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu Medical College and Hospital,Puducherry |
| material support |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and hospital |
| Address |
Aarupadai veedu medical college kirumampakkam
puducherry 607402 |
| Type of Sponsor |
Private 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 E Shanmugavalli |
Aarupadai veedu medical college |
A block ,no.5 ,dept. of anaesthesiology,Aarupadai veedu medical college
pondicherry
Pondicherry
PONDICHERRY |
9940882722
vallijegan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aarupadai veedu medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA I and ASA II |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
drug patch application |
fentanyl drug patch used in one group
placebo patch will be used in one group |
| Comparator Agent |
fentanyl drug patch |
POST CESAREAN SECTION FENTANYL PATCH WILL BE APPLIED TO THE PATIENT |
| Intervention |
fentanyl patch |
applied only once at the end of cesarean section and patient monitored for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
caesarean section |
|
| ExclusionCriteria |
| Details |
complicated pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Better postoperative analgesia |
BASELINE AND 24 HOURS IN THE POSTOPERATIVE PERIOD |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| EARLY AMBULATION,BETTER NEWBORN CARE |
DURING 48 HOURS OF POST OPERATIVE PERIOD |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
20/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/12/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vallijegan@gmail.com].
- For how long will this data be available start date provided 02-01-2023 and end date provided 18-01-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
A STUDY DONE TO EVALUATE THE EFFICACY OF FENTANYL PATCH FOR POST OPERATIVE PAIN RELIEF FOR PATIENTS UDERGOIG CAESAREAN SECTION .SO THAT PATIENT WILL HAVE LESS PAIN AFTER SURGERY AND BETTER QUALITY OF LIFE . |