| CTRI Number |
CTRI/2023/05/053079 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
17/05/2023 |
| 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
|
COMPARISON OF SPINAL ANAESTHESIA WITH LEVOBUPIVACAINE, ROPIVACAINE AND BUPIVACAINE FOR LSCS |
|
Scientific Title of Study
|
A COMPARISION OF SPINAL ANAESTHESIA WITH HYPERBARIC
LEVOBUPIVACAINE 0.5%; ROPIVACAINE 0.75% WITH
BUPIVACAINE 0.5% FOR ELECTIVE LSCS A PROSPECTIVE
RANDOMIZED DOUBLE BLIND STUDY |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SANGRAM M MUNJE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVT, MEDICAL COLLEGE, AURANGABAD |
| Address |
Department of Anaesthesiology,
Government Medical College and Hospital, Aurangabad.
Government Medical College and Hospital, Panchakki road, Aurangabad (Maharashtra) India-431001
Aurangabad
MAHARASHTRA
431001
India |
| Phone |
918855002313 |
| Fax |
-- |
| Email |
sangrammunje01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANGRAM M MUNJE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVT, MEDICAL COLLEGE, AURANGABAD |
| Address |
Department of Anaesthesiology,
Government Medical College and Hospital, Aurangabad.
Government Medical College and Hospital, Panchakki road, Aurangabad (Maharashtra) India-431001
MAHARASHTRA
431001
India |
| Phone |
918855002313 |
| Fax |
-- |
| Email |
sangrammunje01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SANGRAM M MUNJE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
GOVT, MEDICAL COLLEGE, AURANGABAD |
| Address |
Department of Anaesthesiology,
Government Medical College and Hospital, Aurangabad.
Government Medical College and Hospital, Panchakki road, Aurangabad (Maharashtra) India-431001
MAHARASHTRA
431001
India |
| Phone |
918855002313 |
| Fax |
-- |
| Email |
sangrammunje01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional support |
| The Dean, Govt. Medical College & Hospital, Aurangabad |
|
|
Primary Sponsor
|
| Name |
Dean Government Medical College and Hospital Aurangabad |
| Address |
Dean, Government Medical College and Hospital, Panchakki Road, Aurangabad (MAHARASHTRA).
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NA |
Department of Anaesthesiology
Government Medical College & Hospital,
Aurangabad.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Joshi S A |
Government Medical College & Hospital, Aurangabad |
Operation Theatre 4,
Department of Anaesthesiology
Aurangabad
MAHARASHTRA |
9422777903
-
khadkesuchita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, GMC Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Bupivacaine 0.5 â„… (Heavy) 2cc/10mg intrathecally single dose |
Group B - will receive injection Bupivacaine 0.5 â„… (Heavy) 2cc/10mg for spinal anaesthesia |
| Intervention |
Injection Levobupivacaine 0.5â„… (Heavy) 2cc/10mg intrathecally single dose |
Group L - will receive injection Levobupivacaine 0.5â„… (Heavy) 2cc/10mg for spinal anaesthesia
|
| Intervention |
Injection Ropivacaine 0.75â„… (Heavy) 2cc/15mg intrathecally single dose
|
Group R - will receive Injection Ropivacaine 0.75â„… (Heavy) 2cc/15mg for spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant females undergoing elective LSCS surgery under spinal anaesthesia
2. ASA grade II
3. Age 18-35 years
4. Weight 40-70 kg
5. BMI< 30
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal for procedure.
2. History of allergy to drugs, Infection on back.
3. Patient with Uncontrolled hypotension, cardiovascular disease, hepatic or renal disease, bronchospastic disease.
4. ASA Grade 3 or more.
5. Emergency surgeries.
6. Patients taking any psychotropic drugs, Seizure disorder, Coagulopathy, morbid obesity or any contraindication to SA.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The time to reach maximum sensory level of spinal anaesthesia |
2, 4, 6, 8, 10, 15, 20, 25, 30 minutes after spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The onset and duration of sensory & motor block Hemodynamic effects
Adverse effects |
2, 4, 6, 8, 10, 15, 20, 25, 30, 40, 50, 60, 70, 80, 90. 105, 120 minutes after spinal anaesthesia.
Post Operatively - 1, 2, 3, 4, 5, 6 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
01/06/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be published in indexed medical journal after completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hyperbaric bupivacaine is most common used drug in spinal anaesthesia. Levobupivacaine and ropivacaine are two amide local anaesthetic drugs developed in order to address the bupivacaine toxicity. This randomized prospective double-blind study will be conducted to compare the time to reach maximum sensory level, onset and duration of sensory & motor block, hemodynamic and adverse effects after SA with levobupivacaine and ropivacaine. 180 patients between 18 to 35 years, ASA grade II, weight 40-70 kg, BMI< 30 posted for elective LSCS under spinal anaesthesia will be randomly allocated using computer generated randomization list & sealed envelope technique into 3 groups with 60 patients in each group with allocation ratio 1:1:1. In Group L- inj Levobupivacaine 0.5 â„… (Heavy) 2cc, in Group R- inj Ropivacaine 0.75 â„… (Heavy) 2 cc & in Group B- inj Bupivacaine 0.5â„… (Heavy) 2 cc will be given for SA. Time of onset of sensory Block, time of onset of motor Block, peak sensory level will be assessed by loss of pinprick sensation every 2 mins until the highest level is stabilized hemodynamic and adverse effects will be noted. Data analysis will be done by appropriate statistical method with statistical software SPSS Ver. 20. P value less than 0.05 will be taken as significant. |