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
|
|
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
|
|
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.
|