| CTRI Number |
CTRI/2026/04/107679 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparitive study between two medicines-dexmedetomidine and fentanyl for treating severe headaches in mothers after a caesarean section |
|
Scientific Title of Study
|
A comparative study between the use of nebulized Dexmedetomidine and nebulized Fentanyl in parturients experiencing post-dural puncture headache (PDPH) following caesarean section under spinal 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 |
Spandan Paul |
| Designation |
Post Graduate Trainee |
| Affiliation |
KPC Medical College and Hospital |
| Address |
Room 233
Department Of Anaesthesiology
KPC Medical College and Hospital
1F Raja Subodh Chandra Mullick Road
Jadavpur Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
7003280347 |
| Fax |
|
| Email |
spandan.paul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sourabh Roy |
| Designation |
Professor and Head of the Department |
| Affiliation |
KPC Medical College and Hospital |
| Address |
Room 233
Department Of Anaesthesiology
KPC Medical College and Hospital
1F Raja Subodh Chandra Mullick Road
Jadavpur
Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9836275531 |
| Fax |
|
| Email |
drsourabhroy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Spandan Paul |
| Designation |
Post Graduate Trainee |
| Affiliation |
KPC Medical College and Hospital |
| Address |
Room 233
Department Of Anaesthesiology
KPC Medical College and Hospital
1F Raja Subodh Chandra Mullick Road
Jadavpur Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
7003280347 |
| Fax |
|
| Email |
spandan.paul@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC Medical College and Hospital
1F Raja Subodh Chandra Mullick Road
Jadavpur
Kolkata 700032
West Bengal
India |
|
|
Primary Sponsor
|
| Name |
KPC Medical College and Hospital |
| Address |
1F Raja Subodh Chandra Mullick Road
Jadavpur Kolkata
700032 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Spandan Paul |
KPC Medical College and Hospital |
Gyne and Obstetrics OT Complex, Block 2, Ground Floor
1F, Raja Subodh Chandra Mullick Road
Jadavpur
Kolkata
WEST BENGAL |
7003280347
spandan.paul@gmail.com |
| Dr Spandan Paul |
KPC Medical College and Hospital |
Obstetric-1 Ward, Block 2, 1st floor
1F, Raja Subodh Chandra Mullick Road
Jadavpur
Kolkata
WEST BENGAL |
7003280347
spandan.paul@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: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulised Dexmedetomidine |
1 mcg/kg in 4 ml 0.9 % normal saline nebulization 12 hourly |
| Comparator Agent |
Nebulised Fentanyl |
1 mcg/kg in 4 ml 0.9 % normal saline nebulization 12 hourly |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Patients belonging to ASA Grade II and III
Patients giving informed written valid consent.
Subjects that qualified the PDPH criteria as per International Headache Society with headache severity scores of greater than 4
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years and more than 35 years
Known allergy to the anesthetic agents involved in the study
Known case of cardiovascular disorders, specifically bradyarrhythmias.
Patients with chronic treatment of headache of other causes, history of migraine, history of epilepsy, history of substance abuse and current opioid use.
Patients who are uncooperative or disoriented.
Parturients with Body mass index greater than 25 kg/m2
Known cases of gestational hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache severity as measured using Numeric Pain Rating Scale (NPRS) after 24 hours of the first nebulisation using Dexmedetomidine versus Fentanyl |
At baseline,1,6,12,24,48 and 72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of PDPH while using 12 hourly nebulization of dexmedetomidine versus fentanyl.
|
At baseline,1,6,12,24,48 & 72 hours |
| To compare the hemodynamics after 24 hours of nebulization using dexmedetomidine versus fentanyl |
At baseline,1,6,12,24,48 & 72 hours |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/04/2026 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Post
Dural Puncture Headache (PDPH) is a potential complication, attributed to
lumbar puncture, characterized by a bilateral frontal or occipital headache.
These clinical manifestations arise as a consequence of traction on nociceptive
regions subjected to reduced cerebrospinal (CSF) pressure, termed as
intracranial hypotension, subsequent to a sustained CSF leak at the dural
puncture site. The incidence of post-dural puncture headache (PDPH) following
spinal anaesthesia in the obstetric population is around 0.5%–2%.
This study
aims to compare nebulized dexmedetomidine versus nebulized fentanyl for the conservative
treatment of PDPH in parturients after caesarean section under spinal
anesthesia.
|