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CTRI Number  CTRI/2022/05/042612 [Registered on: 18/05/2022] Trial Registered Prospectively
Last Modified On: 09/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Sphenopalatine Ganglion Block For Post-Dural Puncture Headache In Obstetric Parturients  
Scientific Title of Study   Sphenopalatine Ganglion Block For Post-Dural Puncture Headache In Obstetric Parturients: A Randomized Controlled Study 
Trial Acronym  SPG Block for PDPH in Obstetric Parturients 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjeleena Kumar Gupta 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Room no 10, SSRB 5th floor, Institute of Anaesthesiology, Pain and Perioperative Medicine,Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, Delhi 110060

Central
DELHI
110060
India 
Phone  9818422867  
Fax    
Email  anjeleenasgrh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjeleena Kumar Gupta 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Room no 10, SSRB 5th floor, Institute of Anaesthesiology, Pain and Perioperative Medicine,Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, Delhi 110060

Central
DELHI
110060
India 
Phone  9818422867  
Fax    
Email  anjeleenasgrh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjeleena Kumar Gupta 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Room no 10, SSRB 5th floor, Institute of Anaesthesiology, Pain and Perioperative Medicine,Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, Delhi 110060

Central
DELHI
110060
India 
Phone  9818422867  
Fax    
Email  anjeleenasgrh@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram Hospital, New Delhi-110060 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital 
Address  Sir Ganga Ram Hospital, Old Rajinder Nagar,New Delhi, Delhi 110060 
Type of Sponsor  Research institution and hospital 
 
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 Anjeleena Kumar Gupta  Labour Room, 1st Floor, Old Building SGRH  Sir Ganga Ram Hospital, Old Rajinder Nagar, New Delhi, Delhi 110060
Central
DELHI 
9818422867

anjeleenasgrh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O745||Spinal and epidural anesthesia-induced headache during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Paracetamol   1g 8 hrly IV 
Intervention  Sphenopalatine Ganglion Block  1. The patient will be placed supine, with a folded sheet below both the shoulders and head in sniffing position. 2. Intervention • Two long cotton-tipped applicators will be soaked in 4% lidocaine for 30 sec to absorb approximately 0.5 ml fluid. After visual inspection of each nostril for any sign of deformity or blockage, the block will be performed. 3. Distance from the opening of the nares to the mandibular notch directly below the zygoma will be used to estimate the depth of the application.12 4. A cotton-tipped applicator will be inserted into one nostril along the superior edge of middle concha to the posterior wall of the nasopharynx until resistance is met. Lidocaine (4%) 0.5ml will be injected through the hollow cotton swab via a syringe. The procedure will be repeated in the other nostril. If the patient experiences any pain or discomfort, the physician will stop and redirect the applicator. The applicators will be left in place for 5 min in each nostril and then removed.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  All consenting obstetric parturients aged 18-45 years who receive neuraxial block for labour or caesarean delivery with development of PDPH within 72 h of dural puncture will be eligible to participate. 
 
ExclusionCriteria 
Details  Parturient with chronic neurological disorder (epilepsy), bleeding disorder, allergy to local anaesthetics, deformity of the nasal septum, nasal polyps, frequent nosebleeds, those with nasal or sinus surgery within the past year or refusal to participate will be ineligible to participate 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess efficacy of SPG block in terms of pain relief after PDPH  5min, 30 min, 2h, 4h, 8h,12h, 24h and 48 h 
 
Secondary Outcome  
Outcome  TimePoints 
A. To observe at different time intervals
1) Pain relief in supine and sitting position
2) Numerical rating score (NRS) more than 3 in sitting position
B. Time to first analgesic dose after the SPG block
C. Relief in associated symptoms of PDPH (nausea, vomiting, visual changes, neck pain and stiffness)
D. Presence of adverse effects (discomfort, change in taste, numbness in throat, epistaxis) associated with the block
E. Need for epidural blood patch
F. Parturient satisfaction
 
5min, 30 min, 2h, 4h, 8h,12h, 24h and 48 h 
 
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   N/A 
Date of First Enrollment (India)   01/06/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
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 major cause of morbidity in postpartum patients who receive neuraxial block for labour analgesia and/or caesarean delivery. Epidural blood patch (EBP) is the gold standard for its treatment, with a success rate upto 90%. However, it is likely to be associated with various adverse effects, like, subdural haematoma, infection, meningitis, and delayed radicular pain. Also, the procedure itself can cause another inadvertent dural puncture (DP). EBP is, therefore, never considered as the first line of management of PDPH. Patients are often offered conservative treatment including medications, bed rest, abdominal binders, and fluids for at least 24 hours prior to being offered an EBP. The sphenopalatine ganglion (SPG) block is found to be an effective treatment for PDPH in the obstetric population, the block could be offered to patients as a first-line treatment as a way to improve pain scores, reduce the need for medications with potential side effects, and possibly reduce the need for EBP. This randomized study done in 50 parturients aims to evaluate SPG block for management of PDPH in reducing the severity of pain and as a useful adjunct to the traditional treatment with oral or parenteral analgesics in this subset of patients. Parturients will be randomized into two groups:

Conservative group (Group C) – will receive IV paracetamol 1g 8 hrly

Sphenopalatine ganglion block group (Group S) - will receive SPG block

Parturients in both the groups will receive IV fluids (2L/day) and bed rest without pillow.

Relief from headache will be assessed as per the NRS score from 0-10 in supine and sitting position pre-intervention as well as 5min, 30min, 2h, 4h, 8h, 12h, 24h and 48h post-intervention. Time to first analgesic dose after the SPG block, relief in associated symptoms of PDPH, adverse effects associated with the block, need for EBP and parturient satisfaction will be assessed and compared between both the groups.

 
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