| CTRI Number |
CTRI/2025/01/078912 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational, single-center, pilot study comparing the regression of sensory block between 0.75% ropivacaine heavy and 0.5% bupivacaine heavy following spinal anesthesia in pregnant women undergoing cesarean section. |
|
Scientific Title of Study
|
Prospective, comparative, observational, single centre, pilot study to compare regression of sensory block of 0.75 % ropivacaine heavy with 0.5% bupivacaine heavy after subarachnoid block in pregnant patients coming for caesarean 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 |
Dr Shilpa Tiwaskar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
2nd Floor, C wing, Room No 3, Department of Anaesthesiology, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road east, Thane, Maharashtra, India 401107.
Thane
MAHARASHTRA
401107
India |
| Phone |
9820067137 |
| Fax |
|
| Email |
drtiwaskar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Tiwaskar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
2nd Floor, C wing, Room No 3, Department of Anaesthesiology, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road east, Thane, Maharashtra, India 401107.
Thane
MAHARASHTRA
401107
India |
| Phone |
9820067137 |
| Fax |
|
| Email |
drtiwaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpa Tiwaskar |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Bhaktivedanta Hospital and Research Institute |
| Address |
2nd Floor, C wing, Room No 3, Department of Anaesthesiology, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road east, Thane, Maharashtra, India 401107.
Thane
MAHARASHTRA
401107
India |
| Phone |
9820067137 |
| Fax |
|
| Email |
drtiwaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhaktivedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 |
|
|
Primary Sponsor
|
| Name |
Bhaktivedanta Hospital and Research Institute |
| Address |
Bhaktivedanta Swami Marg, Sector 6, Sector 2, Srishti Complex, Mira Road East, Thane, Maharashtra, India 401107 |
| 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 Shilpa Tiwaskar |
Bhaktivedanta Hospital and Research Institute |
2nd Floor, C wing, Room No 3, Department of Anaesthesiology, Srishti Complex, Bhaktivedanta Swami Marg, Mira Road east, Thane, Maharashtra, India 401107.
Thane
MAHARASHTRA |
9820067137
drtiwaskar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhaktivedanta Hospital Ethics Committe For Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Parturient age group: 18-35.
ASA status: I and II.
Uncomplicated singleton pregnancy.
|
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in the study.
ASA statues: greater than II.
Parturients with comorbidities like pregnancy induced hypertension and cardiovascular diseases.
Patients with altered consciousness, significant neurological, psychiatric, neuromuscular, cardiovascular diseases.
Morbid obesity [Body mass index (BMI)greater than 40 kg/m2]
Obstetrical complications like Antepartum Haemorrhage, Pregnancy induced hypertension, raised intracranial pressure.
Contraindications to spinal anaesthesia like deformities of spine, Neurological disorders, Skin infections.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the level of sensory blockade between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy and To assess sensory level regression |
Post administration of subarachnoid block: At 90 seconds,
30 minutes, and
40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)To compare the percentage fall in blood pressure 2)To compare the percentage change in heart rate 3)To compare the level of motor blockade at 40 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy |
1) To compare the percentage fall in blood pressure at:
90 seconds and
5 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy.2) To compare the percentage change in heart rate at:
90 seconds and
5 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy. 3) To compare the level of motor blockade at 40 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
28/01/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study aims to compare the sensory and motor blockade regression following subarachnoid block (SAB) using 0.75% ropivacaine heavy versus 0.5% bupivacaine heavy in post-Caesarean section patients. The primary objective is to evaluate sensory block regression after SAB between the two anaesthetic agents. Secondary objectives include comparing sensory blockade levels at 90 seconds, 30 minutes, and 40 minutes post-SAB, as well as blood pressure and heart rate changes at 90 seconds and 5 minutes after SAB. Additionally, the level of motor blockade at 40 minutes post-SAB will be assessed. The study will include 24 participants aged 18-35, ASA status I and II, with uncomplicated singleton pregnancies, excluding those with comorbidities or contraindications to spinal anaesthesia. Data parameters include demographic details, sensory and motor blockade levels, blood pressure, and pulse rate at specified time intervals. The study will be conducted for over 1 year, with participants randomised into two groups: Group A (bupivacaine) and Group B (ropivacaine). The Primary Endpoints is to compare the level of sensory blockade between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy at: 90 seconds, 30 minutes, and 40 minutes post subarachnoid block also to assess sensory level regression at 30 minutes and 40 minutes after subarachnoid block. Secondary Endpoints of the study is to compare the percentage fall in blood pressure at 90 seconds and 5 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy.To compare the percentage change in heart rate at: 90 seconds and 5 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy. To compare the level of motor blockade at 40 minutes post subarachnoid block between 0.5% bupivacaine heavy and 0.75% ropivacaine heavy |