| CTRI Number |
CTRI/2025/03/082720 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Local anesthetics with opioids and without opioids differ in duration and overall effectiveness for spinal anesthesia during caesarean Section |
|
Scientific Title of Study
|
A Comparative Study Between Intrathecal Ropivacaine Alone Versus Synergistic Effect Of Intrathecal Fentanyl And Ropivacaine In Spinal Anaesthesia 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 Prachi |
| Designation |
Junior Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8859848426 |
| Fax |
|
| Email |
drprachi3008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Tiwari |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
07839310269 |
| Fax |
|
| Email |
rajeev.smch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Garima Chaurasia |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9354134385 |
| Fax |
|
| Email |
drgarima0011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital,Lucknow Road,Banthra,Shahjahanpur,Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Prachi |
| Address |
Varun Arjun Medical College and Rohilkhand Hospital,Lucknow Road,Banthra,Shahjahanpur,Uttar Pradesh,India,242307 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Prachi |
Rohilkhand Hospital ,Banthra ,Shahjahanpur |
Room no -1004,Department of anaesthesia,Varun Arjun Medical College and Rohilkhand
Hospital,Lucknow Road,Banthra
Shahjahanpur
UTTAR PRADESH |
8859848426
drprachi3008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Varun Arjun Medical College ,Banthr a,Shahjahanpur,uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric Ropivacaine 0.75% |
Hyperbaric Ropivacaine 0.75% Alone in 1st group who are going undergoing Caesarean Section in 1 year |
| Comparator Agent |
Hyperbaric Ropivacaine 0.75% with fentanyl
|
Hyperbaric Ropivacaine 0.75% with fentanyl in 2nd group who are undergoing Caesarean Section in 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women scheduled for cesarean section
2.American Society of Anesthesiologists (ASA) physical status I or II
|
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications to spinal anesthesia or opioids
2.ASA physical status III or higher
3.Patients with a history of opioid dependence or chronic pain syndromes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hyperbaric ropivacaine 0.75% with Fentanyl in Spinal Anesthesia Caesarean Section found to have longer duration of sensory and motor blockage then hyperbaric ropivacaine 0.75% alone |
Primary outcome assessed in 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of subarachnoid block, hemodynamic
stability,perioperative analgesia in patients undergoing Caesarean Section are better in patients receiving ropivacine 0.75%
with fentanyl as compared to patients receiving
ropivacine 0.75% alone |
secondary outcome assessed in 1 hour |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
28/04/2025 |
| 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)
|
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
|
The aim of the study is to compare and determine the effects of intrathecally
administered 0.75% hyperbaric ropivacaine alone and 0.75% hyperbaric ropivacaine with
fentanyl (25mcg) on reduction of higher blocks incidence simultaneously assess the onset,
duration of sensory and motor block, quality of subarachnoid block, hemodynamic stability,
perioperative analgesia and any adverse drug reactions in patients undergoing caesarean section. |