| CTRI Number |
CTRI/2026/01/102162 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of sensory blockage attained and variation in hemodynamic parameters in patients receiving divided versus single dose of hyperbaric bupivacaine(spinal anaesthesia drug) for elective cesarean section |
|
Scientific Title of Study
|
A comparison of sensory block and hemodynamic profile in patients receiving fractionated versus bolus dose of hyperbaric bupivacaine for elective cesarean section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana G Nair |
| Designation |
Junior Resident |
| Affiliation |
government medical college, kozhikode |
| Address |
Junior resident
Department of Anaesthesiology
Government medical college, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9019072725 |
| Fax |
|
| Email |
gnairarchana197@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana G Nair |
| Designation |
Junior Resident |
| Affiliation |
government medical college, kozhikode |
| Address |
Department of Anaesthesiology
Government medical college, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9019072725 |
| Fax |
|
| Email |
gnairarchana197@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana G Nair |
| Designation |
Junior Resident |
| Affiliation |
government medical college, kozhikode |
| Address |
Junior resident
Department of Anaesthesiology
Government medical college, Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9019072725 |
| Fax |
|
| Email |
gnairarchana197@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government medical college Kozhikode |
| Address |
Kozhikode government medical college
Po 673008 |
| 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 Archana G Nair |
Government medical college Kozhikode |
Government medical college Kozhikode, Kozhikode
Kozhikode
KERALA |
04952350216
gnairarchana197@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee government medical college Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
obstetric patients without any comorbidities planned foe elective cesarean section |
|
| ExclusionCriteria |
| Details |
patient refusal
comorbidities like hypertension, cardiac diseases, diabetes mellitus, anaemia, coagulopathy
allergy to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the time taken to achieve adequate sensory blockade (T4 level- at the level of
nipple) and the effect on hemodynamic stability in fractionated versus bolus dose of
subarachnoid block in elective cesarean section. |
Every one minute for first 10 minutes followed by every 5 minutes for next 20 minutes, followed by every 15 minutes till 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
07/02/2026 |
| 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="6"
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
|
This prospective observational study aims to evaluate the adequacy of sensory blockade and associated hemodynamic stability in patients undergoing elective cesarean section under spinal anaesthesia. The study will systematically assess the level of sensory blockade achieved and monitor changes in hemodynamic status during the peri-operative period. Data on the extent of sensory level achieved, onset, and adequacy of block will be recorded along with intraoperative hemodynamic variations. The findings of this study are expected to provide clinically relevant information regarding effectiveness and safety profile in routine clinical practice and guide optimization of peri-operative management. |