| CTRI Number |
CTRI/2023/02/049800 [Registered on: 17/02/2023] Trial Registered Prospectively |
| Last Modified On: |
25/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
|
Comparing two local anaesthestic drugs in C-section under spinal anaesthesia |
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Scientific Title of Study
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A comparison and evaluation of hyperbaric Ropivacaine vs hyperbaric Bupivacaine for lower uterine segment caesarean section under spinal anaesthesia – Prospective, Randomised control study in Tertiary care hospital, Chengalpattu District, Tamil Nadu |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Janaki Rethna Sharon |
| Designation |
Post Graduate |
| Affiliation |
Tagore Medical college and hospital |
| Address |
Department of Anaesthesia Tagore Medical college and hospital
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
7904152162 |
| Fax |
|
| Email |
janakirethnasharon@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Shankar Anand |
| Designation |
Associate Professor |
| Affiliation |
Tagore medical college and hospital |
| Address |
Department of Anaesthesiology Tagore Medical college and hospital Rathinamangalam Melakottaiyur Chennai
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
9486476987 |
| Fax |
|
| Email |
drshankarmed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar Anand |
| Designation |
Associate Professor |
| Affiliation |
Tagore medical college and hospital |
| Address |
Department of Anaesthesiology Tagore Medical college and hospital Rathinamangalam Melakottaiyur Chennai
Kancheepuram
TAMIL NADU
600127
India |
| Phone |
9486476987 |
| Fax |
|
| Email |
drshankarmed@gmail.com |
|
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Source of Monetary or Material Support
|
| Tagore Medical college and hospital, Rathinamangalam, Melakottaiyur, Chennai |
|
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Primary Sponsor
|
| Name |
Tagore Medical college and Hospital |
| Address |
Rathinamangalam, Melakottaiyur |
| Type of Sponsor |
Private medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janaki Rethna Sharon |
Tagore Medical college and Hospital |
Department of Anaesthesiology, OG OT
Kancheepuram
TAMIL NADU |
7904152162
janakirethnasharon@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Tagore Medical college and hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric Bupivacaine |
Patient will be administered with 2ml of commercially available hyperbaric 0.5% BUPIVACAINE (10mg) through spinal anaesthesia for 30 patients in a duration 0f 6 months |
| Intervention |
Hyperbaric Ropivacaine |
Patient will be administered with 2ml of commercially available hyperbaric 0.75% ROPIVACAINE through spinal anaesthesia for 30 patients in duration of 6 months |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Caesarean section under ASA II |
|
| ExclusionCriteria |
| Details |
Patients refusal to participate in the study.
Patient who are medical unstable i.e. Patients who come under ASA Grade 3 and above.
Known hypersensitivity to any drugs that are to be studied.
Failed spinal anaesthesia and general anaesthesia required for previous surgery
Presence of Spinal Anaesthesia contra-indications.
-Patients on anticoagulants or anti-platelets therapy or patients with Bleeding diathesis or Coagulopathy.
-Patients with spine deformity and puncture site infection.
-Neurological or Neuromuscular disease.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare and evaluate the clinical efficacy i.e. the motor and sensory blockade of equal doses of hyperbaric 0.75% Ropivacaine with hyperbaric 0.5% Bupivacaine in LSCS under spinal anaesthesia |
Post spinal, every 3 minutes for first 15 minutes, every 5 minutes till end of surgery |
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Secondary Outcome
|
| Outcome |
TimePoints |
| The hemodynamic changes Pulse rate(PR), systolic blood pressure ( SBP), diastolic blood pressure (DBP) that are caused due to the hyperbaric Ropivacaine in lower segment caesarean section under spinal anaesthesia |
Baseline,Pre-spinal,Post spinal every 2 minutes for first 10 minutes, 5 minutes till end of procedure |
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Target Sample Size
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Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
20/02/2023 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
prospective, Randomised control study to compare the efficacy of hyperbaric Ropivacaine over the hyperbaric Bupivacaine (control drug) in lower uterine segment caesarean section under spinal anaesthesia, the motor and sensory blockade and its regression is the primary outcome and to evaluate the hemodynamic changes that are caused due to the hyperbaric Ropivacaine and its alterations with spinal anaesthesia is the secondary outcome
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