| CTRI Number |
CTRI/2020/05/025120 [Registered on: 12/05/2020] Trial Registered Prospectively |
| Last Modified On: |
01/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study on Post Dural Puncture Headache in sitting versus lateral position during spinal anaesthesia in Patients Undergoing Elective Lower Segment Caesarean Section |
|
Scientific Title of Study
|
Comparison of Sitting Versus Lateral Decubitus Position During Spinal Anaesthesia on Occurrence of Post Dural Puncture Headache in Patients Undergoing Elective Lower Segment Caesarean Section: Randomized Clinical Trial at SMS Hospital Jaipur During Year 2019-21 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Proffesor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of anaesthesiology, second floor, Dhanwantari building, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta Khandelwal |
| Designation |
Proffesor |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of anaesthesiology, second floor, Dhanwantari building, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9929338174 |
| Fax |
|
| Email |
drmamtakhandelwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hari Mohan Sharma |
| Designation |
PG Student |
| Affiliation |
SMS Medical College, Jaipur |
| Address |
Department of anaesthesiology, second floor, Dhanwantari building, SMS Medical College, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9799027425 |
| Fax |
|
| Email |
drhmsharma09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, SMS Medical College, JLN marg, Jaipur (Rajasthan)
Pin- 302004 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical College |
| Address |
JLN marg, Jaipur (Rajasthan) Pin- 302004 |
| Type of Sponsor |
Government medical college |
|
|
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 Mamta Khandelwal |
SMS Medical College and Hospital, Jaipur |
Department of Anaesthesiology, second floor. Dhanwantari bhavan, Jiapur
Jaipur
RAJASTHAN |
9929338174
drmamtakhandelwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College Ethics Committee, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Spinal Anaesthesia |
Spinal Anaesthesia will be given during elective caesarean section in two groups in different position.
One group in sitting and another group in lateral decubitus position and PDPH will be compared in above groups... |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients willing to give written informed consent.
2. Age 20 to 40 years.
3. Patients with ASA grade I and II.
4. Patients undergoing elective caesarean section under spinal anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Patients allergic to drug used for spinal anaesthesia.
2. Parturients with contraindication for spinal anesthesia.
3. History of migraine headache.
4. More than one puncture.
5. Any obstetric complications.
6. Chronic use of analgesics.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the number of cases who develop post dural puncture headache |
In the post anaesthesia care unit patients will be interviewed for PDPH on day 1, day2, day3. day4 and day5. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intensity assessment of PDPH by using a numeric rating scale.
To asses the relationship of body mass index with the incidence of PDPH.
To assess the relationship between position and complications.
|
The intensity of PDPH will be evaluated and compared using a Numeric rating scale .
Side effects (Nausea, Vomiting) will be noted
|
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
15/05/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study we aim to compare of sitting versus lateral decubitus position during spinal anaesthesia on occurrence of post dural puncture headache in patients undergoing elective lower segment caesarean section. |