| CTRI Number |
CTRI/2023/05/052299 [Registered on: 04/05/2023] Trial Registered Prospectively |
| Last Modified On: |
03/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the Efficacy of Fentanyl nasal packing on post operative pain in patients undergoing nasal surgeries vs Normal saline pack |
|
Scientific Title of Study
|
Comparing the efficacy of fentanyl nasal packing on postoperative pain in patients undergoing nasal surgeries vs normal saline pack A Randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vignesh M |
| Designation |
1st year PostGraduate |
| Affiliation |
Aarupadai veedu medical college and hospitals |
| Address |
A block first floor Department of ENT and Head and neck surgery Aarupadai veedu medical college and hospitals kirumampakkam puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
8870500311 |
| Fax |
|
| Email |
mvignes1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishanth savery |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical college |
| Address |
A block first floor Department of ENT and Head and neck surgery Aarupadai veedu medical college and hospital kirumampakkam puducherry
A block first floor Department of ENT and Head and neck surgery Aarupadai veedu medical college and hospital kirumampakkam puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894547810 |
| Fax |
|
| Email |
docnishuu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishanth savery |
| Designation |
Professor |
| Affiliation |
Aarupadai veedu medical college and hospitals |
| Address |
A block first floor Department of ENT and Head and neck surgery Aarupadai veedu medical college and hospitals kirumampakkam puducherry
A block first floor Department of ENT and Head and neck surgery Aarupadai veedu medical college and hospitals kirumampakkam puducherry
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9894547810 |
| Fax |
|
| Email |
docnishuu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai veedu medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Aarupadai veedu medical college and Hospital |
| Address |
A block first floor Department of ENT and Head and neck surgery Aarupadai veedu medical college and hospital kirumampakkam puducherry |
| 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 |
| Vignesh M |
Aarupadai veedu medical college and Hospital |
A block first floor Department of ENT and Head and neck surgery Aarupadai veedu medical college and hospital kirumampakkam puducherry
Pondicherry
PONDICHERRY |
8870500311
mvignes1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nasal packing with 25mcg 0f fenatnyl intra nassal route for post operative analgesia in patients undergoing nasal surgeries for patients undergoing nasal surgeries |
Nasal packing with twenty five mcg of fentanyl in each nose in pateints undergoing nasal surgeries for post operative analgesia for first 36 hours |
| Comparator Agent |
Nasal packing with fentanyl vs nasal packing with normal saline as placebo |
Group A will receive Nasal packing with 25mcg of fentanyl in each nostril and Group B will receive normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing nasal surgery for endoscopic polyp removal Nasal bone reduction surgery and septoplasty
Age group 18years to 50years |
|
| ExclusionCriteria |
| Details |
Patient with respiratory disorder
Patient with pyschiatric disorder
Patient with bradycardia and cardiac anamolies
Patients with migraine and vascular headache |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the post operative pain in patients undergoing nasal surgeries in the interval of 6hours 12hours 24 hours and 36 hours |
To assess the post operative pain in patients undergoing nasal surgeries in the interval of 6hours 12hours 24 hours and 36 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of postoperative analgesia |
To assess the pain at 1hour 2nd hour and 3rd hour post operative period |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
10/05/2023 |
| 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="8"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The purpose of this study is to asses the pain in patients under going nasal surgeries in the postoperative period and to find out the effect of fentanyl in intra nasal absorption as compare to routine nasal packing by keeping 25mcg of fentanyl soaked merocel pack in the each nose. |