| CTRI Number |
CTRI/2023/07/055822 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
The amount of pain and the need for painkillers after caesarean delivery: effect of the time of day |
|
Scientific Title of Study
|
Pain intensity and analgesic requirement after caesarean section: Effect of daytime variation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S M Kushal |
| Designation |
Postgraduate |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
No. 4 1st cross, Kushal arcade, Halasahalli road, behind Varthur police station, Varthur, Bangalore
Department of anesthesiology, Tamaka, kolar
Kolar
KARNATAKA
560087
India |
| Phone |
7760505880 |
| Fax |
|
| Email |
dr.smkushal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi MAdhusudhana |
| Designation |
Professor |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
Sri devaraj urs medical college
Tamaka, Kolar
Kolar
KARNATAKA
563103
India |
| Phone |
9845287591 |
| Fax |
|
| Email |
ravijaggu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S M Kushal |
| Designation |
Postgraduate |
| Affiliation |
Sri Devaraj urs medical college |
| Address |
No. 4 1st cross, Kushal arcade, Halasahalli road, behind Varthur police station, Varthur, Bangalore
department of anesthesiology,
Tamaka,
Kolar
KARNATAKA
560087
India |
| Phone |
7760505880 |
| Fax |
|
| Email |
dr.smkushal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S M kushal
Sri devaraj urs medical college, Tamaka, Kolar
Karnataka |
|
|
Primary Sponsor
|
| Name |
S M Kushal |
| Address |
Sri Devaraj urs medical college,
Tamaka, Kolar |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| S M Kushal |
Sri Devaraj urs medical college |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S M Kushal |
Sri devaraj urs Medical college |
Department of anaesthesiology,
Kolar
KARNATAKA |
7760505880
dr.smkushal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
-Patients above 18 years of age
-undergoing cesarean section in the morning and afternoon
-ASA 2 |
|
| ExclusionCriteria |
| Details |
- Patient refusal
-Patients allergic to local anaesthetics
-Patients with coagulopathies
- Patients with cardiac diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome is to assess the intensity of pain and the analgesic requirement post cesarean section
|
for 24 hours post the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the requirement of analgesics in the postoperative period in patients undergoing cesarean section in the morning and afternoon. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
14/08/2023 |
| 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="6"
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
|
Cesarean section (CS) is one
of the most common surgeries occurring in the world.
Even though there are various treatment options available
to reduce the postoperative pain, it still remains a problem in clinical
practice. Postoperative pain is an unavoidable complication of CS, seriously
affecting the patient’s recovery and satisfaction and increasing the
postoperative length of stay and direct cost.
It is found that there is
not enough data available on the role of day time variation in post cesarean
pain. Hence the present study will be done to compare the postoperative
analgesic requirements between women undergoing cesarean section in the morning
and afternoon. |