| 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
|
|
|
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
|
|
|
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. |