| CTRI Number |
CTRI/2024/12/077797 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison between nerve block located behind nose and oral medical management for headache that occur after spinal anaesthesia in cesarean section |
|
Scientific Title of Study
|
Comparison between Sphenopalatine ganglion block versus conservative management for postdural puncture headache in cesarean section |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prema I Tondi |
| Designation |
Postgraduate |
| Affiliation |
Kodagu Institute of Medical sciences |
| Address |
Department of Anesthesiology,
Kodagu Institute of Medical sciences teaching hospital , madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
9945275198 |
| Fax |
|
| Email |
Prematondi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Taranandan A |
| Designation |
Associate professor |
| Affiliation |
Kodagu Institute of Medical sciences |
| Address |
department of anaesthesiology Kodagu Institute of Medical sciences teaching hospital , madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
9481267056 |
| Fax |
|
| Email |
drtararoshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Taranandan A |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Kodagu Institute of Medical sciences |
| Address |
Department of anaesthesiology Kodagu Institute of Medical sciences teaching hospital , madikeri
Kodagu
KARNATAKA
571201
India |
| Phone |
9481267056 |
| Fax |
|
| Email |
drtararoshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kodagu Institute of Medical Sciences Madikeri,Kodagu district madikeri 571201 karnatak india |
|
|
Primary Sponsor
|
| Name |
Kodagu institute of medical sciences |
| Address |
Kodagu Institute of Medical sciences teaching hospital 571201 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr TARANANDAN A |
Kodagu Institute of Medical Sciences, teaching hospital Madikeri 571201 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prema |
Kodagu institute of medical sciences , teaching hospital |
Postop ward in maternal and child health block. Kodagu institute of medical sciences,Madikeri ,571201,
Kodagu
KARNATAKA |
9945275198
Prematondi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kodagu Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conservative treatment |
Tablet paracetmol 500mg thrice a day |
| Intervention |
Sphenopalatine ganglion block |
Cotton swab soaked in 4% lignocaine with adernaline ,inserted through nostril directed parallel to floor of nose until resistance encountered |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Obstetric patient with diagnosed PDPH who underwent Lower segment caesarean section under subarachnoid block.
2. Age more than 18years |
|
| ExclusionCriteria |
| Details |
1. History of allergy to local anesthetic
2. Had opioid taken less than 12hrs before the study inclusion.
3. Preeclampsia, Eclampsia, chronic hypertension
4. Known coagulopathy.
5. Nasal septal deviation
6. Nasal polyp
7. History of nasal bleeding
8. Nasal and basal bone fracture |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of sphenopalatine ganglion block and conservative measures in PDPH and objective is to compare the efficacy of sphenopalatine ganglion block and conservative treatment with respect to reduction in pain score. |
15 min, 60 min, 6-hour,12 hour and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Onset of analgesia
2.Hemodynamic effects BP, PR, SpO2
3.Proportion of patient requiring rescue analgesia
4.Requirement of epidural blood patch |
15 min, 60 min, 6-hour,12 hour and 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
12/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/12/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim is comparing the efficacy of sphenopalatine ganglion block and conservative measures in PDPH and objective is to compare the efficacy of51 sphenopalatine ganglion block andconservative treatment with respect to reduction in pain score at 15 min, 60 min, 6-hour,12 hour and 24 hours in PDPH. In both the groups sphenopalatine ganglion block and conservative management will be given by my colleague in ward for patient of PDPH, after 5 min I am going to assess pain score. Patient will be assessed using NRS Numeric Pain Rating Scale 0-10 0-3 = no pain 3-7 = moderate pain 8-10 = worst possible Pain score will be assessed at 15 min, 60 min, 6-hour,12 hour and 24 hours in both groups after an intervention and time at which NRS score declines will be considered as onset of analgesia in both the groups. At 15 min, 60 min, 6-hour, 12 hour and 24-hour vital parameters like BP, PR, SPO2 will be recorded. Along with pain, patients will be asked about the sensation of nausea and vomiting. After 6 hours if NRS score is >7 it means pain is not relieved, patient will be marked as a failure, then rescue therapy will be considered. Patients in both groups without pain relief after 24 h will be considered for Epidural blood patch. Any adverse events that occur in study will be treated according to standard protocol. |