| CTRI Number |
CTRI/2025/11/097688 [Registered on: 19/11/2025] Trial Registered Prospectively |
| Last Modified On: |
19/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of low dose and standard dose of fentanyl patch on adult patients undergoing spine surgery for post operative pain relief |
|
Scientific Title of Study
|
A comparison of transdermal fentanyl patch 12.5 microgram versus 25 microgram for post operative analgesia in adults undergoing spine surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jamie Ann Varghese |
| Designation |
Post Graduate |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8281987912 |
| Fax |
|
| Email |
jamie.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Malavika Kulkarni |
| Designation |
Head of department, Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
9844241620 |
| Fax |
|
| Email |
malavika.kulkarni@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Jamie Ann Varghese |
| Designation |
Post Graduate |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology,
Kasturba Medical College, Manipal-576104
Udupi
KARNATAKA
576104
India |
| Phone |
8281987912 |
| Fax |
|
| Email |
jamie.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal. Tiger Circle Road, Madhav Nagar, Manipal. Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Self sponsor |
| Address |
Kasturba Medical College, Manipal-576104 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Jamie Ann Varghese |
Kasturba Medical College |
Department of Anaesthesiology, Kasturba Medical College, Manipal - 576104, Karnataka, India
Udupi
KARNATAKA |
8281987912
jamie.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (3) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 undergoing elective posterior spine instrumentation and stabilisation surgery under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Opioid -dependent and sensitive patients, patients on antidepressant drugs, haemodynamically unstable, morbidly obese patients, peptic ulcers, uncontrolled systemic illness (Systemic hypertension and diabetes mellitus), impaired kidney or liver functions, history of intake of non-steroidal anti- inflammatory drugs or opioids within 24h before surgery or allergy to the used medications, coagulation defect, local infection at the site of application of transdermal patch, patient refusal will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Comparison of mean Numerical Rating Scale at different time intervals
2. First time of asking for rescue analgesia
3. Consumption of total Diclofenac and Tramadol consumption in 72 hours
4. Assessment of post operative sedation using Ramsay Sedation Score |
30 minutes for the first two hours, 4 hour intervals for the next 12 hours, 12 hourly interval until 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Post operative hemodynamics - Mean arterial pressure, heart rate
2. POst operative side effects - post operative nausea and vomiting, skin irritation and itching at the site of application of patch, hypotension, bradycardia, dyspnea, urinary retention |
72 hours |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/12/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The purpose of the study is to compare the efficacy of 12.5 mcg/h and 25 mcg/h fentanyl patches in controlling post operative pain in patients that undergo posterior spine stabilisation and instrumentation surgeries. |