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CTRI Number  CTRI/2023/12/060809 [Registered on: 27/12/2023] Trial Registered Prospectively
Last Modified On: 25/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of blocking the nerve present in the back of head and nerve present in nose for treatment of headache after spinal anaesthesia 
Scientific Title of Study   Efficacy of greater occipital nerve block versus sphenopalatine ganglion block for treatment of post dural puncture headache after spinal anaesthesia: A randomised clinical 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 R Hravei 
Designation  Junior resident  
Affiliation  Uttar Pradesh university of medical sciences  
Address  Department of Anaesthesia room no.305 UPUMS, Saifai, Etawah, UP

Etawah
UTTAR PRADESH
206130
India 
Phone  9389588809  
Fax    
Email  hraveipao50@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Urvashi Yadav 
Designation  Associate professor 
Affiliation  Uttar Pradesh university of medical sciences  
Address  Department of Anaesthesia room no.305 UPUMS, Saifai, Etawah, UP

Etawah
UTTAR PRADESH
206130
India 
Phone  7500186161  
Fax    
Email  drurvikgmu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Urvashi Yadav 
Designation  Associate professor 
Affiliation  Uttar Pradesh university of medical sciences  
Address  Department of Anaesthesia room no.305 UPUMS, Saifai, Etawah, UP

Etawah
UTTAR PRADESH
206130
India 
Phone  7500186161  
Fax    
Email  drurvikgmu@gmail.com  
 
Source of Monetary or Material Support  
Uttar Pradesh University of Medical Sciences,Department of Anaesthesiology,Saifai, Etawah 
 
Primary Sponsor  
Name  R Hravei 
Address  Swami Vivekanand hostel 5th floor B502 UPUMS Saifai Etawah 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R Hravei  Uttar Pradesh University of Medical Sciences  Department of anaesthesiology Room number 329
Etawah
UTTAR PRADESH 		 9389588809

hraveipao50@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Uttar Pradesh University of Medical Sciences, Saifai ,Etawah  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O894||Spinal and epidural anesthesia-induced headache during the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Greater occipital nerve block  Greater occipital nerve block using 2ml bupivacaine 0.5% plus 4mg dexamethasone.1 week 
Comparator Agent  Sphenopalatine ganglion block  Sphenopalatine ganglion block using 0.5% bupivacaine plus 4mg dexamethasone.1week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  BMI 18.5 to 24.9kg/m2. ASA class l and ll . Patient who developed PDPH with headache score more or equal to 4 on NRS  
 
ExclusionCriteria 
Details  Patient refusal,scalp infection, PIH, chronic headache, nasal polyp , DNS, epistaxis, major psychiatric condition 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Numerical rating scale headache score more or equal to 4  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Patient Satisfaction score  48 hours 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   15/02/2024 
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)
Modification(s)  		 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 20-09-2025 and end date provided 20-09-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
       Post Dural Puncture Headache (PDPH) is a common and severe complication following spinal anesthesia. Around10-20% of patients who have lumbar puncture for any indication experience headache. Headache is usually bilaterally symmetrical and is fronto-occipital in location, PDPH occurs due to leakage of cerebro-spinal fluid (CSF) at the site of dural puncture that exceeds the spinal fluid production resulting in low CSF pressure, this traction precipitates symptoms on pain sensitive structures such as meninges and blood vessels, cranial nerves and upper cervical nerves.
Initially PDPH is managed conservatively with bed rest, adequate hydration, analgesic anti-emetics and caffeine.
Epidural blood patch (EBP) has been considered the gold standard treatment for severe PDPH and when conservative measure failed. However, EBP is an invasive procedure with failure rate of 15-20% worsening the PDPH by inadvertently creating the dural puncture rents.
Recently, minimally invasive methods like greater occipital nerve and Sphenopalatine ganglion block had been used in the management of PDPH
This study aims to compare the efficacy of greater occipital nerve block with sphenopalatine ganglion block for post dural puncture headache after spinal anesthesia. 
Our primary objective is to compare the headache score by numerical rating score (NRS) in supine and upright position after intervention during 48 hours. 
This study will be started after getting approval from Institutional Ethical Committee. After explaining the proposed technique, informed consent will be taken from all patients. Conservative management Including bedrest, adequate hydration (oral/intravenous fluid) analgesics (inj. paracetamol IV 15mg/kg 8hrly will be given to all patients with PDPH. The patients with headache score persist ≥4 even after conservative management will be included in the study. Baseline numerical rating score of headaches will be noted both in sitting and supine position. Using a computer-generated randomization table, patients will be randomly allocated into 2 groups.

The two groups allocated are:

·GONB (Group A) –The patient will be placed in sitting position with flexion of the neck. An imaginary line will be drawn from external occipital protuberance to mastoid process and on the medial one third of the line, block will be performed using 2ml bupivacaine 0.5 % plus 4mg (1ml) dexamethasone on both sides.
·SPGB (Group B) –The patients will be placed supine with shoulders slightly elevated to flex the neck and extend the head. Long cotton nasal pack soaked with 2ml of bupivacaine 0.5% plus 4mg(1ml) of dexamethasone will be placed intranasally in the sphenopalatine region for 10 minutes.
                    Headache score will be recorded before the block (baseline),30 minutes,1h, 2h, 6h, 12h, 24h and 48h and at 1 week. After the intervention at any-time, if the headache score >4/10 on NRS score in upright position, injection diclofenac 75mg will be given as rescue analgesia and this will be considered as block failure. If there is not adequate pain relief in 48h patient will be considered for epidural blood patch in the groups.                 
 
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