| CTRI Number |
CTRI/2026/03/106010 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare hemodynamic effect of sitting vs lateral position during spinal anesthesia in elective cesarean delivery with hyperbaric ropivacaine |
|
Scientific Title of Study
|
THE EFFECT OF SITTING vs LATERAL POSITION DURING THE INDUCTION OF SPINAL ANAESTHESIA FOR CESAREAN DELIVERY ON HAEMODYNAMIC PARAMETERS WITH HYPERBARIC ROPIVACAINE A PROSPECTIVE RANDOMIZED CONTROL STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KAREDDY AISHWARYA REDDY |
| Designation |
Post graduate |
| Affiliation |
D Y PATIL SCHOOL OF MEDICINE |
| Address |
A-block department of anaesthesia D Y PATIL SCHOOL OF MEDICINE
DR D Y PATIL VIDYANAGAR SECTOR 5 nerul navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
8297020009 |
| Fax |
|
| Email |
kareddyaishwarya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BALASAHEB GOVARDHANE |
| Designation |
Professor |
| Affiliation |
D Y PATIL SCHOOL OF MEDICINE |
| Address |
A-block department of anaesthesia D Y PATIL SCHOOL OF MEDICINE
DR D Y PATIL VIDYANAGAR SECTOR 5 nerul navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819631719 |
| Fax |
|
| Email |
gbalasaheb690@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BALASAHEB GOVARDHANE |
| Designation |
Professor |
| Affiliation |
D Y PATIL SCHOOL OF MEDICINE |
| Address |
A-block department of anaesthesia D Y PATIL SCHOOL OF MEDICINE
DR D Y PATIL VIDYANAGAR SECTOR 5 nerul navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819631719 |
| Fax |
|
| Email |
gbalasaheb690@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY , D Y PATIL UNIVERSITY SCHOOL OF MEDICINE AND HOSPITAL , NERUL, NAVI MUMBAI, MAHARASHTRA,INDIA |
|
|
Primary Sponsor
|
| Name |
D Y PATIL SCHOOL OF MEDICINE AND HOSPITAL nerul Navi Mumbai |
| Address |
A-block Department of Anaesthesia Ayyappa Temple Rd, Dr D Y Patil Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra 400706 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KAREDDY AISHWARYA REDDY |
D Y PATIL UNIVERSITY SCHOOL OF MEDICINE AND HOSPITAL NERUL NAVI MUMBAI |
a-block Department of anesthesia D Y PATIL school of medicine, Dr D Y PATIL Vidyanagar ,sector 5 , Nerul Navi Mumbai
a-block Department of anesthesia D Y PATIL school of medicine, Dr D Y PATIL Vidyanagar ,sector 5 , Nerul Navi Mumbai
Thane
MAHARASHTRA |
8297020009
kareddyaishwarya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH OF D Y PATIL MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
left lateral position |
Position - left lateral position
drug - Ropivacaine 0.75% heavy
duration :given over 10-15 seconds
frequency - at L3-L4 intervertebral space prior to beginning of surgery
|
| Comparator Agent |
Sitting |
Position - Sitting
drug - Ropivacaine 0.75% heavy
duration :given over 10-15 seconds
frequency - at L3-L4 intervertebral space prior to beginning of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Elective cesarean delivery done under spinal anesthesia
Patients between 18 years to 35 years
ASA grade I and II
Patients giving consent for study
|
|
| ExclusionCriteria |
| Details |
Patients with contraindication for spinal anaesthesia
patients with history of hypertensive disorders anaemia heart disease diabetes placenta previa polyhydromnios oligohydromnios obesity multiple pregnancies
height less than 150cms |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To compare the effects of lateral versus sitting position During induction of spinal anaesthesia on haemodynamic variable. (heart rate, blood pressure and mean arterial pressure.) |
BASELINE
T0(immediately after administering spinal drug)
Immediately after positioning supine
3mins
5mins
10mins
15mins
20mins
30mins
40 mins
50mins
60 mins
Post op
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate time required to achieve highest sensory level T6 and motor Block (Modified Bromage score 3).
• To evaluate the time taken to give spinal anaesthesia.
• To evaluate number of attempts required.
• To evaluate side-effects: nausea, vomiting and PDPH.
• To evaluate satisfaction of the patient.
|
BASELINE
T0(immediately after administering spinal drug)
Immediately after positioning supine
3mins
5mins
10mins
15mins
20mins
30mins
40 mins
50mins
60 mins
Post op
|
|
|
Target Sample Size
|
Total Sample Size="220"
Sample Size from India="220"
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)
|
22/04/2026 |
| 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="2"
Months="0"
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
|
This prospective randomized controlled study compares the effects of sitting versus left lateral position during induction of spinal anaesthesia for elective cesarean delivery using hyperbaric ropivacaine on maternal haemodynamic parameters. Spinal anaesthesia, though widely preferred for cesarean section, commonly causes hypotension and bradycardia, which may adversely affect both mother and fetus. A total of 220 ASA I–II parturients aged 18–35 years will be randomized into two equal groups: Group A (left lateral position) and Group B (sitting position). Standardized spinal anaesthesia will be administered, and heart rate, systolic/diastolic blood pressure, and mean arterial pressure will be recorded at predefined intervals. Secondary outcomes include time to achieve sensory (T6) and motor block, number of attempts, procedure time, side effects, and patient satisfaction. The study aims to identify the position associated with better haemodynamic stability and block characteristics, thereby improving maternal safety during cesarean delivery. |