| CTRI Number |
CTRI/2024/06/068667 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Prospective observational study to know incidence of backache and headache in pregnant women undergoing spinal anaesthesia |
|
Scientific Title of Study
|
Prospective observational study for incidence of post dural puncture backache and post dural puncture headache in parturients undergoing cesarean delivery under spinal anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shravanthi B S |
| Designation |
Junior resident in department of anaesthesiology and critical care |
| Affiliation |
Vijaynagar institute of medical sciences,Ballari |
| Address |
Department of anaesthesiology, Vijayanagar institute of medical sciences, Cantonment , Ballari
Bellary KARNATAKA 583104 India |
| Phone |
7022897338 |
| Fax |
|
| Email |
shravanthibs1998@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Srinivasalu D |
| Designation |
Professor |
| Affiliation |
Vijaynagar institute of medical sciences, Ballari |
| Address |
Department of anaesthesiology, Vijayanagar institute of medical sciences, Cantonment , Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9845224880 |
| Fax |
|
| Email |
drsrinivasd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Srinivasalu D |
| Designation |
Professor |
| Affiliation |
Vijaynagar institute of medical sciences, Ballari |
| Address |
Department of anaesthesiology, Vijayanagar institute of medical sciences, Cantonment , Ballari
Bellary KARNATAKA 583104 India |
| Phone |
9845224880 |
| Fax |
|
| Email |
drsrinivasd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vijaynagar institute of medical sciences,Cantonment,Ballari,Karnataka,India,583104 |
|
|
Primary Sponsor
|
| Name |
Vijaynagar institute of medical sciencesBallari |
| Address |
Vijaynagar institute of medical sciences, Cantonment, Ballari, Karnataka, India, 583104 |
| 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 Shravanthi B S |
Vijaynagar institute of medical sciences |
Room no.99, Department of Obstetrics and Gynaecology, emergency operation theatre, Ballari Bellary KARNATAKA |
7022897338
shravanthibs1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijaynagar institute of medical sciences,Ballari,Institutional ethics committee, VIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All pergnant women aged 18-45 years undergoing cesarean section under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patient refusal, Contraindications of spinal anaesthesia like coagulopathy, Infection at the site of puncture, Hemodynamically unstable, Eclampsia, Allergic to local anaesthetics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the incidence of PDPH and PDPB. |
Postoperatively the incidence of PDPB and PDPH will be assessed on day 1,3,5 of hospital stay and after 1month, 2month and 3 months after discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes include factors like : body mass index, pregnancy induced hypertension, poor quality of spinal landmarks, number of skin punctures, needle passes, space level change, size of spinal needle, number of attempts, spinal needle redirections, 1st pass success, second provider, occurrence of bloody tap, number of previous caesarean sections, leakage of CSF |
Postoperatively the incidence of PDPB & PDPH will be assessed on day 1,3,5 of hospital stay & after 1month, 2month & 3 months after discharge |
|
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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)
|
25/06/2024 |
| 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="1" Months="0" 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
|
The study aims at knowing incidence of PDPB and PDPH in 150 parturients undergoing cesarean delivery under spinal anaesthesia.Study to include pregnant women of
age 18 - 45 years undergoing cesarean section under spinal anaesthesia. The
number of attempts (skin punctures, needle passes and needle redirections) for
successful dural puncture will be noted. Successful identification of the subarachnoid
space with one skin puncture and no redirection of the spinal needle will be
considered as first pass success, landmark quality (good, poor, none), needle passes, space level change,
second provider, bloody tap, intra operative fluid given will be observed. Postoperatively
severity of PDPB will be assessed by visual analogue scale (VAS 1‑10)
score; 0 = no backache,1–3 = mild backache, 4–7 = moderate backache, >7 =
severe backache. And severity of PDPH will be assessed by NRS
scale. On the scale, 0 is the absence of headache, 1–3 is mild pain, 4–6 is
moderate pain, and 7– 10 is severe pain (disabling; unable to perform daily
activities). Postoperatively the incidence of PDPB and incidence of PDPH will
be assessed on day 1,3, 5 of hospital stay. In the study phone number of the
patient/attender will be taken, going to call them back after 1month, 2month, 3
month to know the well being of the patient, any side effects in particular to
PDPB. Statistical Analysis; The collected data will be entered in
the Microsoft Excel 2016 and will be analysed wih IBM SPSS Statistics for
Windows, Version 29.0.(Amonk,NY:IBM Corp)
|