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CTRI Number  CTRI/2024/06/068282 [Registered on: 04/06/2024] Trial Registered Prospectively
Last Modified On: 03/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparative study of methyprednisolone and sphenopalatine block in spinal headache after obstretrics and gynecological surgery 
Scientific Title of Study   A study to compare efficacy of oral methylprednisolone and sphenopalatine block in postdural puncture headache 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tania Singh 
Designation  consultant 
Affiliation  Command Hospital Air Force Bangalore 
Address  Dept of obstetrics and gynecology, Command Hospital Air Force Bangalore, Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  9906077562  
Fax    
Email  Singhtania151187@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohd Rasheed 
Designation  Professor 
Affiliation  Command Hospital Air Force Bangalore 
Address  Dept of obstetrics and gynecology, Command Hospital Air Force Bangalore, Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  9906904070  
Fax    
Email  rashiddr81077@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ankushsinh Bhadoria 
Designation  Post graduate 
Affiliation  Command Hospital Air Force Bangalore 
Address  Dept of obstetrics and gynecology, Command Hospital Air Force Bangalore, Bangalore

Bangalore
KARNATAKA
560007
India 
Phone  9033126361  
Fax    
Email  ankush9691@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital Air Force Bangalore,Cambridge Rd, Cambridge Layout, Jogupalya, Bengaluru, Karnataka 560007 
 
Primary Sponsor  
Name  Dr Mohd Rasheed 
Address  Dept of Obs and Gynec , Command hospital air force bangalore, Cambridge Rd, Cambridge Layout, Jogupalya, Bengaluru, Karnataka 560007 
Type of Sponsor  Other [guide] 
 
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 Nagaraja N  Command Hospital Air Force Bangalore  Room no. 1, Dept of obstetrics and gynecology, Command Hospital Air Force Bangalore, Bangalore
Bangalore
KARNATAKA 
8826152797

deptofobsgynchafb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Command Hospital (airforce) Bangalore  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  Methylprednisolone  Methylprednisolone 8 mg OD for 5 days 
Comparator Agent  Sphenopalatine block  Sphenopalatine block with Bupivacaine 2% intranasal route sos with maximum three times a day for 5 days 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Patients who developed postdural puncture headache after spinal anesthesia in obstetrics and gynaecology surgical procedure
 
 
ExclusionCriteria 
Details  Patients with h/o migraine or other types of headache
Neurological disorders
Cerebrovascular accidents
Cerebrovascular infection
Conditions where methylprednisolone is contraindicated
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Relief with symptoms by Visual Analogue scale  on day 0 followed by day 1, day 2, day 3,day 4 and day 5 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of days with headache according to visual analogue scale
2. Toal Hospitalization days due to headache  
1. On day 0(on the day of presentation), day 1, day 2, day 3,day 4 & day 5
2. Total number of days patient required to stay in hospital due to headache  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   15/06/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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 - NO
Brief Summary  

Need for the study :

The international headache society (IHS) defines PDPH(post dural puncture headache) as a headache occurring within 5 days of a lumbar puncture caused by CSF leakage through the dural puncture. PDPH is one of most common complications in spinal anesthesia after obstetrics and gynaecological surgeries.  The PDPH clinically is very characteristic, with frontal and/or occipital headache, exacerbated with orthostatism, and relieved in decubitus, which appears 6 to 72 hours after the procedure (90% starts up to 3 days after the procedure and 66% in the first 48 hours). Other symptoms may also be associated, such as nausea, dizziness, stiff neck, visual and/or auditory changes. Without any treatment, PDPH can persist for about two weeks (it is estimated that 72% of cases will resolve spontaneously after 7 days)Incidence of PDPH ranges from 4-18% in obstetrics and gynaecology surgical cases. It is often exhausting, hindering the mother from taking care of the newborn baby in obstetrics cases. This causes raised healthcare costs, extended stay in the hospital, and frequent visits to the emergency department. PDPH can be managed with conservative treatment like bed rest, good hydration, analgesics like paracetamol, methylxanthines like caffeine and gamma aminobutyric acid like pregabalin or gabapentin. Some researchers have also used corticosteroids for the management of PDPH. PDPH resistant to all therapy can be managed with epidural blood patch. Corticosteroids have been widely used for as multimodal analgesia protocols for managing postoperative pain. Oral methylprednisolone has been used for low pressure headache associated with syndrome of spontaneous intracranial hypotension (SSIH). Hence it has been used in the treatment of PDPH. Sphenopalatine ganglion block (SPGB), a non-invasive intervention with minimal adverse effects and high efficacy, had been tried as a treatment modality of PDPH. SPGB efficacy has been proved in the management of migraine and facial pain. There are a number of case reports and case series reporting the success of SPGB for the management of spinal headache in obstetric patients. But due to its minimal invasive nature along dyscomfort to patient while application and easy acceptibility of oral medication for patients, we decided to study and compare the efficacy of oral methylprednisolone and sphenopalatine ganglion block in postdural puncture headache after spinal anesthesia in obstetrics and gynaecology surgical cases.

Aim and objectives:

To observe and compare the efficacy of oral methylprednisolone and sphenopalatine ganglion block in postdural puncture headache after spinal anesthesia in obstetrics and gynaecology surgical cases

Methodology:

Patients who developed postdural puncture headache(PDPH) after obstetrics and gynaecology surgeries will be selected for study in command hospital Air Force Bangalore and randomnly assigned to two groups. Group A (n=15) cases will be managed with oral methylprednisolone 8 mg once a daily for 3 days along with other conservative treatment like bed rest, adequate hydration therapy. Group B (n=15) will be managed with sphenopalatine ganglion block using bupivacaine 2 % intranasal route for spinal headache along with other conservative treatment like bed rest and adequate hydration therapy. Both groups will be assessed with visual analogue scale(VAS) graded 0-10 for pain severity post treatment at just before starting of treatment (0 hr) then followed by at 12 hr, 24 hr, 48 hr, and 72 hr. Zero was considered as no pain and 10 as severe pain; 0-1 (no headache),2-4 (mild headache), 5-7 (moderate headache) and 8-10 (severe headache). If headache was persist even after 3 days of treatment the autologous epidural blood patch (EBP) will be given to patients. Both groups will be compared and assessed for efficacy of methylprednisolone compared to sphenopalatine block in treating PDPH.

 
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