| CTRI Number |
CTRI/2024/10/075613 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Which transdermal patch is better for post operative analgesia:fentanyl or buprenorphine? |
|
Scientific Title of Study
|
A Comparative study between transdermal patches of buprenorphine and fentanyl for post operative analgesia following infraumbilical surgeries under regional anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sailee Mahale |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department Of Anaesthesiology, Goa Medical College Bambolim Goa
North Goa
GOA
403507
India |
| Phone |
9637336356 |
| Fax |
|
| Email |
mahalesailee10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharmila Borkar |
| Designation |
Associate Professor |
| Affiliation |
Goa Medical College |
| Address |
Department Of Anaesthesiology Goa Medical College
North Goa
GOA
403202
India |
| Phone |
9922851257 |
| Fax |
|
| Email |
drsharmila_borkar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharmila Borkar |
| Designation |
Associate Professor |
| Affiliation |
Goa Medical College |
| Address |
Department Of Anaesthesiology Goa Medical College
North Goa
GOA
403202
India |
| Phone |
9922851257 |
| Fax |
|
| Email |
drsharmila_borkar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College
Bambolim Goa India
403202 |
|
|
Primary Sponsor
|
| Name |
GOA MEDICAL COLLEGE |
| Address |
Goa Medical College Bambolim Goa India
403202 |
| Type of Sponsor |
Government 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 SaileeMahale |
Goa Medical College |
Operation Theatre and ward Goa Medical College Bambolim North Goa
North Goa
GOA |
09637336356
mahalesailee10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOA MEDICAL COLLEGE INSTITUITIONAL 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 |
transdermal patch buprenorphine |
transdermal buprenorphine patch of 10mg releasing fentanyl @10mcg/hr will be applied 12 hrs prior to surgery.
Patient will be induced with spinal anaesthesia with 3cc of 0.5% heavy bupivacaine and pulse NIBP nad SpO2 will be monitored at every 15 mins interval and postoperative for 3 days |
| Comparator Agent |
Transdermal patch fentanyl |
Transdermal patch of fentanyl of 3mg releasing fentanyl @25mcg/hr will be applied 12 hrs prior to surgery
Patient will be induced with 3cc of 0.5% heavy bupivacaine and pulse NIBP and SpO2 will be monitored at every 15 mins interval and post operative for 3 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 21 years to 60 years giving informed consent
ASA I and II |
|
| ExclusionCriteria |
| Details |
Patients allergic to buprenorphine and fentanyl
Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see whether fentanyl or buprenorphine transdermal patch is a good analgesic |
12 hrs
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare whether transdermal fentanyl or buprenorphine patch is associated with more side effects |
12 hrs
3 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2024 |
| 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 Yet Recruiting |
| 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
|
Patients will be randomly divided into 2 groups. • Transdermal patch will be applied 12 hours prior to the surgery. • Buprenorphine patch of 10mg releasinf buprenorphine at the rate of 10mcg/hr and fentanyl patch of 3mg releasing fentanyl at the rate of 25mcg /hr will be used. • For induction, spinal anaesthesia with 3cc of 0.5% heavy bupivacaine will be given . No adjuncts will be added. • Intraoperatively,pulse, noninvasive blood pressure,ECG and SpO2 will be monitored at every 15 minutes interval. • Post operatively, pulse , blood pressure and respiratory rate , total duration of analgesia, requirement of rescue analgesic(iv paracetamol 1 gm) and side effects like nausea ,vomiting ,pruritis, sedation and respiratory depression will be noted for 3 days. • Patients will be explained about Visual Analogue Scale (VAS), which is a 10cm scale, where in 0:No pain 1-3:mild pain 4-7:moderate to severe pain 8-9:very severe pain 10:worst pain ever
Statistical analysis:Data collected will be analyzed using the latest SPSS software to find out clinical and statistical significance. A p value of <0.05 will be considered as statistically significant. |