| CTRI Number |
CTRI/2025/02/080789 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role of ultrasound guided nerve block in relieving post spinal anaesthesia headache after caesarean section |
|
Scientific Title of Study
|
Ultrasound guided Bilateral Greater Occipital Nerve Block in the treatment of PostDural Puncture Headache after Caesarean Section : A Prospective Observational Study |
| 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 Dipendra Singh |
| Designation |
Post Graduate Trainee Student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Kamrup Metro
Kamrup
ASSAM
781008
India |
| Phone |
8638771617 |
| Fax |
|
| Email |
dipendraunistar136@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiranya Kumar Saharia |
| Designation |
Associate Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
9435087643 |
| Fax |
|
| Email |
sahariahiranya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipendra Singh |
| Designation |
Post Graduate Trainee Student |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care Gauhati Medical College and Hospital Bhangagarh Kamrup Metro
Kamrup
ASSAM
781032
India |
| Phone |
8638771617 |
| Fax |
|
| Email |
dipendraunistar136@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Bhangagarh, Guwahati- 781032 |
|
|
Primary Sponsor
|
| Name |
Dipendra Singh |
| Address |
Post Graduate Trainee Student,
Department of Anaesthesiology and Critical Care, Gauhati Medical College and Hospital, Bhangagarh, Guwahati-781032 |
| Type of Sponsor |
Other [self] |
|
|
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 Dipendra Singh |
Gauhati Medical College and Hospital, Guwahati |
Department of Anaesthesiology,Bhangagarh, Guwahati-781032
Kamrup
ASSAM |
8638771617
dipendraunistar136@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI |
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 |
Dr Dipendra Singh |
Post Graduate Trainee, Department of Anaesthesiology,GMCH Guwahati |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) ASA score II
2) Term gestation 37-42 weeks
3) Caesarean section under spinal anaesthesia
4) All spinal anaesthesia done with 25G needle
Quincke needle
5) Informed and written consent provided |
|
| ExclusionCriteria |
| Details |
1) Refusal of patient to take part in the study
2) Meningitis, encephalitis , migraine
3) Neuralgia , chronic headache
4) Cerebrovascular diseases, haemorrhage, intracranial tumours
5) Pre-eclampsia , vertebral column anomalies , renal, hepatic ,cardiac diseases.
6) Blood diathesis
7) Seizure disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Ultrasound guided Bilateral Greater Occipital Nerve Block using Visual Analog Score |
baseline, 10 min, 2 hrs, 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
26/02/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This is a prospective, Observation study conducted in Department of Anaesthesiology and Critical are , Gauhati Medical College and Hospital . The study will be carried out in the post operative caesarean section patients who has postdural puncture headache. The aim of this study is to evaluate the effectiveness of ultrasound guided greater occipital nerve block as a therapeutic modality for the treament of postdural puncture headache in patients undergoing spinal anaesthesia after caesarean section. The primary objective of this study is to evaluate the effectiveness of ultrasound guided greater occipital nerve block using Visual Analog Score. |