| CTRI Number |
CTRI/2026/01/100399 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Nasal Treatments Versus Standard Care for Headache Following Spinal Anaesthesia |
|
Scientific Title of Study
|
Hospital based prospective and double blind randomised control trial - Comparision of efficacy of sphenopalatine ganglion block with intra nasal 4% lignocaine v/s intra nasal dexmedetomidine v/s conservative treatment of post dural puncture headache in patients undergoing surgery 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 |
Shivangi sachan |
| Designation |
Junior resident |
| Affiliation |
Ganesh Shankar vidyarthi memorial medical college |
| Address |
C-1/204 Indira nagar , Kalyanpur Kanpur
Swaroop nagar . Kanpur Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH
208026
India |
| Phone |
9025153358 |
| Fax |
|
| Email |
shivangisachan11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Verma |
| Designation |
Professor , department of anaesthesia. |
| Affiliation |
Ganesh Shankar vidyarthi memorial medical college |
| Address |
GSVM MEDICAL COLLEGE , Swaroop nagar Kanpur
Swaroop nagar . Kanpur Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9336107410 |
| Fax |
|
| Email |
anil_16021976@rediffmail.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Shivangi sachan |
| Designation |
Junior resident |
| Affiliation |
Ganesh Shankar vidyarthi memorial medical college |
| Address |
C-1/204 Indira nagar , Kalyanpur Kanpur
Swaroop nagar . Kanpur Uttar Pradesh
Kanpur Nagar
UTTAR PRADESH
208026
India |
| Phone |
9025153358 |
| Fax |
|
| Email |
shivangisachan11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gsvm medical college
PIN code - 208002
India |
|
|
Primary Sponsor
|
| Name |
GSVM MEDICAL COLLEGE KANPUR |
| Address |
Gsvm medical college . Swaroop nagar . Kanpur . Pin- 208002
India |
| 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 shivangi sachan |
Gsvm medical college Kanpur |
Department of surgery
Department of orthopaedic
Department of urology
Department of OBG
Swaroop nagar Kanpur . 208002
Kanpur Nagar
UTTAR PRADESH |
9025153358
shivangisachan11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conservative (standard) management for PDPH as per institutional protocol. |
Conservative therapy is the accepted first-line management for post-dural puncture headache. It provides a standard baseline against which the efficacy of active interventions (SPG block with lignocaine or dexmedetomidine) can be measured.
Dose - 1 gm
Frequency - 3 times a day
Route of administration- intra venous
Total duration - 5 days . |
| Intervention |
Intra nasal dexmedetomidine |
Dose - 50 microgram
Frequency - whenever the patient complains of PDPH
Route of administration- intra nasal
Total duration - 5 days . |
| Intervention |
Intranasal 4% lignocaine |
Topical intranasal local anaesthetic applied to the mucosa over the pterygopalatine fossa produces a transnasal SPG block that relieves PDPH pain by interrupting parasympathetic and sensory transmission to the meninges
Dose - 60 mg
Frequency - whenever the patient complains of PDPH
Route of administration- intra nasal
Total duration - 5 days . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent .
Patients in ASA Grade 1,2,3
Pateints within 5 days of dural puncture
Patients returning to OPD with symptoms of PDPH after discharge |
|
| ExclusionCriteria |
| Details |
Patients not giving consent
Patients with chronic headache, tension headache, migraine, Cluster headache.
Patients with known nasal septal deviation or abnormalities such as polyps, intranasal tumors
Patients with a history of any disorders involving the nose such as sinusitis, rhinitis
Patients with a history of allergy to study medications (Lignocaine or Dexmedetomidine or paracetamol )
Patients on analgesic or undergoing treatment for headache.
Patients with a history of addiction i.e. alcohol abuse or substance abuse. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome of the study is to assess the Efficacy of SPGB for the treatment of PDPH and conservative management assessed by reduction in pain score |
Outcomes wil be assessed at baseline
15mins
30mins
1 hour
2 hours
6hours
12 hours
24hours
48 hours
72hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome of the study is to assess the Efficiency of the Sphenopalatine block & conservative management by the assessment of onset & duration of analgesia, as well as the development of any side effects associated with block , total dose of rescue analgesia & hospital discharge & patient satisfaction. |
Outcomes will be assessed at
Baseline
15mins
30mins
1 hour
2 hours
6 hours
12 hours
24 hours
48 hours
72 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
17/01/2026 |
| 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="0"
Months="2"
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
|
Post-dural puncture headache (PDPH) is a common and distressing complication following spinal anaesthesia. Conservative management often provides delayed relief and may prolong hospital stay. Sphenopalatine ganglion block (SPGB) using intranasal agents is a minimally invasive technique that has shown promising results in the management of PDPH. This hospital-based, prospective, double-blind randomized controlled trial aims to compare the efficacy of intranasal 4% lignocaine, intranasal dexmedetomidine, and conservative treatment in patients developing PDPH after surgery under spinal anaesthesia. The primary outcome will be the reduction in headache severity, while secondary outcomes will include duration of analgesia, need for rescue analgesics, and incidence of adverse effects. The results of this study may help identify an effective, safe, and non-invasive treatment option for PDPH.
|