| CTRI Number |
CTRI/2024/01/062119 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs 0.5% levobupivacaine versus 0.75% ropivacaine under spinal anaesthesia in caesarean delivery for the duration of effect of pain relief and to know which drug is better for long duration od pain relief. |
|
Scientific Title of Study
|
A randomised comparative study for the efficacy of 0.5% hyperbaric Levo bupivacaine versus 0.75% hyperbaric ropivacaine in parturients undergoing lower segment caesarean section under spinal anaesthesia |
| 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 Chandrashekhar Chatterjee |
| Designation |
Senior professor |
| Affiliation |
Sawai man Singh medical college, Jaipur |
| Address |
Department of anaesthesiology, sawai man Singh medical college,Jaipur,Rajasthan
Jaipur
RAJASTHAN
302016
India |
| Phone |
9828088092 |
| Fax |
|
| Email |
Chatterjee.chandrashekhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Chhipa |
| Designation |
Resident doctor |
| Affiliation |
Sawai man Singh medical college, Jaipur |
| Address |
Department of anaesthesiology
Sawai man Singh medical college Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
8505052367 |
| Fax |
|
| Email |
drsandeepchhipa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Chhipa |
| Designation |
Resident doctor |
| Affiliation |
Sawai man Singh medical college, Jaipur |
| Address |
Department of anaesthesiology
Sawai man Singh medical college Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
8505052367 |
| Fax |
|
| Email |
drsandeepchhipa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology,sawai man Singh medical college |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and hospital |
| Address |
Department of anaesthesiology,SMS Medical College,Jaipur |
| 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 ChandraShekhar Chatterjee |
Gangori Hospital attached under SMS HOSPITAL |
First floor,department of anaesthesiology Dhanvanthri complex
Jaipur
RAJASTHAN |
9828088092
Chatterjee.chandrashekhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS MEDICAL COLLEGE AND ATTACHED HOSPITALS,JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric bupivacaine undergoing LSCS under subarachnoid block |
Injection 0.5% hyperbaric bupivacaine 1.8ml under spinal anaesthesia and requirement of post operative analgesia |
| Comparator Agent |
Hyperbaric ropivacaine undergoing LSCS under subarachnoid block |
Injection 0.75% hyperbaric ropivacaine 1.8ml under spinal anaesthesia and requirement of post operative analgesia |
| Intervention |
To find out which drug is better in terms of post operative analgesia in parturients undergoing LSCS under spinal anaesthesia |
To find out the efficacy of 0.5% hyperbaric bupivacaine 1.8ml versus 0.75% hyperbaric ropivacaine 1.8ml in parturients undergoing LSCS under spinal anaesthesia and post operative analgesia efficacy.study will be terminated after first dose of rescue analgesia given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Parturients willing to participate in the study undergoing LSCS under subarachnoid block with age group of 18 to 40 years and ASA grade II |
|
| ExclusionCriteria |
| Details |
Parturient should not be a part of other study,non co-operative parturient,history of allergy or hypersensitivity to any drug of study,any deformity or local sepsis in spinal lumbar region,severe hypovolemia,any bleeding or coagulation abnormalities,parturients receiving tranquillisers,phenothiazines or other CNS depressants including alcohol,any major pre-existing comorbidities such as COPD,neurological,cardiovascular,metabolic,hepatic,respiratory or renal disease |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare mean time of onset of sensory and motor blockade between the study groups,level of sensory blockade at different time intervals until the highest level achieved,time duration of sensory and motor block,requirement of first rescue analgesia in post operative period between the study groups. |
1,2,3,5,10,15,20,25,30,40,50,60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare hemodynamic variables at different time intervals such as SBP,DBP,MAP and SPO2,frequency of side effects if any |
1,2,3,5,10,15,20,25,30,40,50,60 minutes |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
05/02/2024 |
| 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
|
In this study we will compare the efficacy of hyperbaric bupivacaine and hyperbaric ropivacaine in parturients undergoing LSCS under spinal anaesthesia and requirement of first rescue analgesia. In this study we will assess and compare mean time onset of sensory and motor blockade , level of sensory blockade at different time intervals until highest level achieved,time duration of sensory and motor block,requirement of first dose of rescue analgesia in post operative period,hemodynamic variables (pulse rate,SBP,DBP,MAPAND SPO2) at different time intervals. |