| CTRI Number |
CTRI/2021/05/033653 [Registered on: 17/05/2021] Trial Registered Prospectively |
| Last Modified On: |
13/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of postoperative pain relief by using fentanyl given as transdermal patch and epidural infusion |
|
Scientific Title of Study
|
Effectiveness Of Transdermal And Epidural Fentanyl, Along With Epidural Ropivacaine On Post Operative Pain Among The Patients Undergoing Major Infra Umbilical Abdominal Surgeries: A Cross-Sectional, (Two Group) Comparative Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiran K |
| Designation |
PG Resident |
| Affiliation |
MOSC Medical College Kolenchery |
| Address |
Dept. Of Anaesthesia
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9995789860 |
| Fax |
|
| Email |
kirankizhakkini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shaloo Ipe |
| Designation |
Professor and HOD |
| Affiliation |
MOSC Medical College Kolenchery |
| Address |
Dept. Of Anaesthesiology and Critical Care
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9495126722 |
| Fax |
|
| Email |
shaloo_ipe@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kiran K |
| Designation |
PG Resident |
| Affiliation |
MOSC Medical College Kolenchery |
| Address |
Dept. Of Anaesthesia
MOSC Medical College
Kolenchery
Ernakulam
KERALA
682311
India |
| Phone |
9995789860 |
| Fax |
|
| Email |
kirankizhakkini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. Of Anaesthesiology and Critical Care
MOSC Medical College
Kolenchery
Ernakulam 682311 |
|
|
Primary Sponsor
|
| Name |
Dept Of Anaesthesiology and Critical Care |
| Address |
MOSC Medical College
Kolenchery
Ernakulam Pin : 682311 |
| 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 |
| Kiran K |
MOSC Medical College |
Operating room and ICU,
Dept. Of Anaesthesiology and Critical Care
Ernakulam
KERALA |
9995789860
kirankizhakkini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18-60 years
2. ASA I-II
3. Body mass index 20 - 35kg/m2
4. Laparotomy with below umbilicus incision. |
|
| ExclusionCriteria |
| Details |
1. Known allergy to the study drug
2. Contraindication to neuraxial blockade
3. Patients with cognitive impairment
4. Uncontrolled cardiovascular / hepatic / renal disease or impaired pulmonary function.
5. Patients having intolerance to opioid
6. Pregnant and breastfeeding females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post-operative pain scores in patients receiving transdermal and epidural fentanyl |
24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the adverse events in patients receiving transdermal and epidural fentanyl |
24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
24/05/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
post operative analgesia is important for early postoperative recovery. In this study, I am comparing two different routes of administration of fentayl. ie, transdermal and epidural routes, in patients undergoing major infra umbilical abdominal surgeries. |