| CTRI Number |
CTRI/2020/03/023754 [Registered on: 04/03/2020] Trial Registered Prospectively |
| Last Modified On: |
07/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ganglion Block for Post-dural Puncture Headache. |
|
Scientific Title of Study
|
Transnasal sphenopalatine ganglion block for post-dural puncture headache of moderate severity : an observer blind, parallel group 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 |
Dr Bimal Kumar Mandal |
| Designation |
Postgraduate Trainee |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
Institute of Post Graduate Medical Education and Research.
244 A.J.C. Bose Road, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830752592 |
| Fax |
|
| Email |
brpbm2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Ghosh |
| Designation |
Associate Professor, Dept. of Anesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research. |
| Address |
Institute of Post Graduate Medical Education and Research.
244 A.J.C. Bose Road, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9903663696 |
| Fax |
|
| Email |
dr.sujata444@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Ghosh |
| Designation |
Associate Professor, Dept. of Anesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research. |
| Address |
Institute of Post Graduate Medical Education and Research.
244 A.J.C. Bose Road, Kolkata 700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9903663696 |
| Fax |
|
| Email |
dr.sujata444@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGMER KOLKATA
244 A. J. C. Bose Road, Kolkata - 700 020 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Sujata Ghosh Associate Professor Dept of Anesthesiology |
Maternity Ward, Dept. of Gynae & Obst. |
Institute of Post Graduate Medical Education and Research.
244 A.J.C. Bose Road Kolkata 700020
Kolkata
WEST BENGAL |
9903663696
dr.sujata444@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&R Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Transnasal Sphenopalatine Ganglion Block |
Patient supine with head in sniffing position. After
visualy inspecting each nostril two long cotton tipped applicators soaked in 0.9% NS (Normal Saline) will be inserted into
one nostrin and advanced until resistance is met,
procedure will be repeated in the other nostril. The
applicator will be left in place for 10 minutes and 1 ml of 0.9% NS (Normal Salaine) will be applied to the canal of the
applicator and kept another 10 minutes after that
applicators are removed.
|
| Intervention |
Transnasal Sphenopalatine Ganglion Block |
Patient supine with head in sniffing position. After visualy inspecting each nostril two long cotton tipped applicators soaked in 2% lidocaine will be inserted into one nostrin and advanced until resistance is met, procedure will be repeated in the other nostril. The applicator will be left in place for 10 minutes and 1 ml of lidocaine will be applied to the canal of the applicator and kept another 10 minutes after that applicators are removed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
All postpartum women aged 18-40 years who received Neuraxial anaesthesia for cesarean delivery and are diagnosed with a moderately severe post dural puncture headache within 48 hours post partum. |
|
| ExclusionCriteria |
| Details |
History of Migraines and chronic headache.
Bleeding disorder.
Gross deformity or infection of the nasal septum, nasal polyp, nasal or sines surgery within the past year.
Chronic narcotic user.
Neurological disorder.
pregnancy induced hypertension.
Allergy to local anaesthetics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief of Post dural puncture headache |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effect of Drug |
Immediate |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/03/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
70 patients will be randomly devided in to two different group: SP(N=35), SS (N=35) [SP=Sphenoealatine ganglion block ; SS=Sham block] BP(SBP, DBP) Pulse Rate, VAS score will be studied at base line, 30 minutes, 4 hours, 24 hours, 48 hours after the procedure and by telephonic followup at 7th day.
For SPG block - Patients supine with sniffing position :- After visually inspecting each nostril two long cotton tipped applicators will be soaked in 2% lidocaine applied and advanced until resistance is met. The procedure will be repeated in the other nostril. The applicators will be left in place for 10 minutes and 1 ml of lidocaine reapplied through the canal of the applicator and kept for another 10 minutes, after that applicators will be removed.
For SS block :- same as the procedure of SPG block here 0.9% NS (Normal Saline) will be used instead of lidocaine.
Calculation of the study is based on anticipated difference in headache intensity scored by VAS at 48 hours following the block procedure. It is calculated that 35 patients would be required in order to detect difference of 20 mm in VAS score between groups with 80% power and 5% probability type 1 error. Sample size calculation has been done by "n Master 2.0" software (Dept. of Bio-statistics, Christian Medical College, Vellore 2011)
Study will be randomized to SPG block arm and the Sham block arm using the computer generated randomized list. Allocation concealment will be by serial number opaque sealed envelop [SNOSE] technique.
|