| CTRI Number |
CTRI/2025/07/089968 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Nasal Lignocaine Spray for Relief of Post-Dural Puncture Headache in Obstetric Patients: A Randomized Controlled Trial
|
|
Scientific Title of Study
|
COMPARING THE EFFICACY OF SPHENOPALATINE
GANGLION BLOCK FOR TREATMENT OF POSTDURAL
PUNCTURE HEADACHE USING 2 percent LIGNOCAINE SPRAY
NASALLY AMONG OBSTETRIC POPULATION: RANDOMIZED
CONTROLLED TRIAL. |
| 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 Rohit Parashar |
| Designation |
Postgraduate student |
| Affiliation |
Dr. S.N Medical college, Jodhpur |
| Address |
Roomno.206 Intern pg hostel 6
MDM hospital Jodhpur, Rajasthan
Roomno.206 Intern pg hostel 6
MDM hospital Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9810145178 |
| Fax |
|
| Email |
rohitparashar400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam meena |
| Designation |
Professor |
| Affiliation |
Dr. S.N Medical college, Jodhpur |
| Address |
Main OT
Umaid hospital Jodhpur, Rajasthan
Mail ot
Umaid hospital Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8302537601 |
| Fax |
|
| Email |
neelamneki1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Parashar |
| Designation |
Postgraduate student |
| Affiliation |
Dr. S.N Medical college, Jodhpur |
| Address |
Roomno.206 Intern pg hostel 6
MDM hospital Jodhpur, Rajasthan
Roomno.206 Intern pg hostel 6
MDM hospital Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9810145178 |
| Fax |
|
| Email |
rohitparashar400@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr SN MEDICAL COLLEGE department of anaesthesiology, Sector-D, Shastri Nagar, Jodhpur,
Rajasthan 342003 India |
|
|
Primary Sponsor
|
| Name |
Dr. S.N Medical college, jodhpur |
| Address |
Residency Rd, Sector-D, Shastri Nagar, Jodhpur, Rajasthan 342003 |
| 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 |
| Dr Rohit Parashar |
MDM Hospital |
Department of
Anaesthesiology
JANANA OT
Sector-H, Shastri Nagar
Jodhpur.
Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN |
9810145178
rohitparashar400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr SNMC Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G440||Cluster headaches and other trigeminal autonomic cephalgias (TAC), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group ( standard care ) |
Conservative measures, including bed rest, hydration, caffeine intake,
and analgesics, will be provided.
If conservative measures fail, an EBP may be performed as per standard
clinical practice. |
| Intervention |
Sphenopalatine Ganglion Block (SPGB) |
The SPGB will be performed using a transnasal approach. A cotton-
tipped applicator soaked in local anesthetic (e.g., 2% lidocaine) will be
inserted into the nostril and advanced towards the sphenopalatine
ganglion.
The applicator will be left in place for 10-15 minutes to allow sufficient
time for the anesthetic to take effect. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Obstetric patients experiencing PDPH following spinal anesthesia.
• Young patients (aged 18-40) experiencing PDPH following lumbar
puncture after spinal anesthesia.
• Patients who provide informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with contraindications to SPGB, such as severe nasal septum
deviation or active nasal infection.
Patients with a history of allergy to local anesthetics.
Patients with significant comorbid conditions that may interfere with
study outcomes.
• Patients who decline to participate or withdraw consent during the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain relief, measured using a visual analog scale (VAS) for headache
intensity at multiple time points: baseline, 30 minutes, 1 hour, 6 hours,
12 hours, 24 hours, and 48 hours post-intervention. |
Pain relief, measured using a visual analog scale (VAS) for headache
intensity at multiple time points: baseline, 30 minutes, 1 hour, 6 hours,
12 hours, 24 hours, and 48 hours post-intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate the Efficiency of SPGB in Terms of Time to Relief
Determine the average time taken for SPGB to provide pain relief compared to other treatments.
Analyze the duration of pain relief provided by SPGB.
Examine Patient Outcomes Satisfaction
Assess patient-reported outcomes including pain scores, quality of life, overall satisfaction with SPGB treatment. |
Pain relief, measured using a visual analog scale (VAS) for headache
intensity at multiple time points
baseline, 30 minutes, 1 hour, 6 hours,
12 hours, 24 hours, 48 hours post intervention. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/07/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 of this study is to evaluate the efficacy and efficiency of sphenopalatine ganglion block (SPGB) in the management of post-dural puncture headache (PDPH) in obstetric patients. Primary objective 1. Assess the Efficacy of SPGB in Relieving PDPH Measure the degree of pain relief in obstetric patients following SPGB administration. Compare the pain relief outcomes of SPGB with other conventional treatments for PDPH. Secondary objective 1. Evaluate the Efficiency of SPGB in Terms of Time to Relief Determine the average time taken for SPGB to provide pain relief compared to other treatments. the duration of pain relief provided by SPGB. 2. Examine Patient Outcomes and Satisfaction Assess patient-reported outcomes including pain scores, quality of life, and overall satisfaction with SPGB treatment.
|