| CTRI Number |
CTRI/2022/09/045158 [Registered on: 01/09/2022] Trial Registered Prospectively |
| Last Modified On: |
05/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prospective Observational Study of Prevalence of Chronic pain in patient after caesarean section delivery in a Tertiary Care Hospital |
|
Scientific Title of Study
|
Prospective Observational Study of Prevalence of Chronic pain in patient after caesarean section delivery in a Tertiary Care Hospital |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogita Patil |
| Designation |
Additional Professor |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Anesthesiology 1st floor, old building KEM Hospital, Parel, Mumbai- 400012
kem hospital parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833935747 |
| Fax |
|
| Email |
yogitapatil76@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogita Patil |
| Designation |
Additional Professor |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Anesthesiology, 1st floor , old building, KEM Hospital Parel Mumbai- 400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833935747 |
| Fax |
|
| Email |
yogitapatil76@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogita Patil |
| Designation |
Additional Professor |
| Affiliation |
Seth GSMC and KEM Hospital |
| Address |
Department of Anesthesiology, 1st floor old building KEM Hospital Parel Mumbai- 400097
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9833935747 |
| Fax |
|
| Email |
yogitapatil76@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GSMC and KEM Hospital |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Minakshi Kalam |
KEM Hospital, Parel Mumbai |
Parel
Mumbai
MAHARASHTRA |
07972687182
myk17021991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
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
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women who have undergone elective caesarean
section (multi+ primi gravida)
2. Patient undergoing elective LSCS under spinal
anaesthesia or General Anaestheia |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate
2. Patient posted for emergency LSCS
3. Patient with a history of major psychiatric
disorder and inability to undertake a personal or
telephone interview.
4. Patient under chronic use of opioid
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of chronic pain of women undergoing
caesarean section and to know the association
between factors leading to chronic pain. |
To assess pain at 24hours, 1 month and 3 month after caesarean section delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess the post-caesarean health related quality of
life using WHO Quality of Life Assessment
Questionnaire
|
To assess pain at 24hours, 1 month and 3 month after caesarean section delivery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="200" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/09/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/12/2022 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Chronic post-surgical pain after caesarean section delivery remains a major clinical problem which can be associated with impaired activities of daily life and health related quality of life. Purpose of the study is to evaluate prevalence of chronic pain after 24hrs, at 1 month and 3 month after caesarean delivery and to assess the post-caesarean health related quality of life. Patients will be interviewed preoperatively and 24 h postoperatively. Telephone follow-up interviews will be conducted at 1 month and 3 month following surgery. 24hrs after caesarean section patient will be interviewed in person and using Numerical Rating Scale (NRS) pain will be assessed. At 1 month and 3 month patient will be interviewed telephonically and assessment of quality of life post-surgery will be done using WHO Quality of life assessment questionnaire. |