| CTRI Number |
CTRI/2019/11/022069 [Registered on: 20/11/2019] Trial Registered Prospectively |
| Last Modified On: |
13/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Headache after spinal anaesthesia comparing two techniques for treatment of headache following spinal anaesthesia |
|
Scientific Title of Study
|
Efficacy of intranasal sphenopalatine ganglion block by lignocaine spray for the treatment of post dural puncture headache following spinal anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHUCHI SMITA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Indira gandhi institute of medical sciences |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, IGIMS,PATNA
Patna
BIHAR
800014
India |
| Phone |
8709421084 |
| Fax |
|
| Email |
smitashuchi5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHUCHI SMITA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Indira gandhi institute of medical sciences |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, IGIMS,PATNA
Patna
BIHAR
800014
India |
| Phone |
8709421084 |
| Fax |
|
| Email |
smitashuchi5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRAKASH KUMAR DUBEY |
| Designation |
PROFESSOR |
| Affiliation |
Guide |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,IGIMS, PATNA
Patna
BIHAR
800014
India |
| Phone |
|
| Fax |
|
| Email |
pkdubey@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute Of Medical Sciences, Patna |
|
|
Primary Sponsor
|
| Name |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
SHEIKHPURA ,PATNA
800014 |
| 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 |
| SHUCHI SMITA |
indira gandhi institute of medical sciences |
department of anaesthesia
first floot,ward block,IGIMS
sheikhpura
patna
Patna
BIHAR |
8709421084
smitashuchi5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, IGIMS, PATNA |
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 |
| Comparator Agent |
sphenopalatine ganglion block by conventional method |
patients will recieve normal saline spray followed by cotton soaked in lignocaine 2%. |
| Intervention |
sphenopalatine ganglion block by lignocaine spray |
intanasal spray will be done using an insulin syringe to give treatment - Lignocaine spray 10% and cotton soaked in normal saline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
asa assigned class 1 to 3, experiencing a post dural puncture headache within 7 days of dural puncture, patients giving consent to participate, vas score of pain 3 or more than 3, age 18 or more than 18 years |
|
| ExclusionCriteria |
| Details |
allergy to study medication, <18 years og age, pain score on presentation <3/10 of headache, known nasal septal deviation or abnormalities such as polyp, patients with history of any disorder of nose such as sinusitis, rhinitis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of sphenopalatine ganglion block for the treatment of post dural puncture headache following spinal anaesthesia |
Vas score will be assessed at 1/2hr,1hr,2hr,24hr,48hr,72hr and number of blocks required for relief |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effect of sphenopalatine ganglion block, if any |
upon discharge patients will be instructed for report when symptoms appear |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2019 |
| Date of Study Completion (India) |
14/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Plan to publish on completion of the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The purpose of this study is to evaluate two techniques for sphenopalatine ganglion block for post dural puncture headache. Lignocaine spray is a relatively non-invasive technique as compared to the standard technique. |