| CTRI Number |
CTRI/2023/02/049861 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
19/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
spinal anaesthesia with , hyperbaric bupivacaine vesrsus ropivacaine |
|
Scientific Title of Study
|
A comparative study of the efficacy of Spinal Anaesthesia
with Hyperbaric Ropivacaine 0.75oh and Hyperbaric
Bupivacaine 0.5Yo in patients undergoing infraumbilical
surgeries. |
| Trial Acronym |
In spinal , bupivacaine versus ropivacaine |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJitendra kalbande |
| Designation |
Assistant professor |
| Affiliation |
Department of anaesthesiology,AIIMS Raipur |
| Address |
Dept of anaesthesiology aiims raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
08368326094 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJitendra kalbande |
| Designation |
Assistant professor |
| Affiliation |
Department of anaesthesiology, AIIMS Raipur |
| Address |
Dept of anaesthesiology aiims raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
08368326094 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJitendra kalbande |
| Designation |
Assistant professor |
| Affiliation |
Department of anaesthesiology,AIIMS Raipur |
| Address |
Dept of anaesthesiology aiims raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
08368326094 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmental support, Department of Anaesthesiology, AIIMS Raipur |
|
|
Primary Sponsor
|
| Name |
Jitendra kalbande |
| Address |
Department of anaesthesiology , AIIMS Raipur |
| 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 Jitendra kalbande |
AIIMS Raipur |
A block OT complex,4th floor, Department of anaesthesiology, Tatibandh, AIIMS Raipur
Raipur
CHHATTISGARH |
08368326094
drjitu222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric bupivacaine 0.5% |
Hyperbaric bupivacaine 0.5%, 3ml will be given intrathecally and duration of intervention, will be,till the patient require first dose of intravenous rescue analgesics. |
| Intervention |
Hyperbaric ropivacaine 0.75% |
Hyperbaric ropivacaine 0.75%, 3ml will be given intrathecally and duration of intervention, will be,till the patient require first dose of intravenous rescue analgesics. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18- 60 years ,ASA 1 and 2 both male and female, duration of surgery - minimum 1 hr |
|
| ExclusionCriteria |
| Details |
Patients with contraindication to spinal anaesthesia, allergy to drug being used, patient with neurological deficit, pregnancy women |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of onset of sensory block, time taken to achieve T10 segment sensory block, maximum height of block, time to 2 segment regression and complete sensory recovery. Onset of motor block, time taken to achieve complete motor block, complete motor recovery |
0, 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 40, 50, 60, 90, 120 min, time till requirement of rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, non invasive blood pressure, peripheral oxygen saturation , any adverse effects |
0, 2, 4, 6, 8, 10, 12, 14, 20, 25, 30, 40, 50, 60, 90, 120 min, time till patients shifted to ward from postoperative unit. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
28/02/2023 |
| 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" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Both bupivacaine and ropivacaine is amide group of local anaesthetics ,but bupivacaine has more cardiotoxicity. Further ropivacaine has the advantage of the differential blockade. Therefore ropivacaine allows early ambulation, less DVT, and other advantages of ambulation. On the other hand, as per minimal local anaesthetics concentration, ropivacaine has a comparable potency to bupivacaine at higher doses but lesser potency at lower dosages. As a result when administered in a ratio of 1.5:1 with bupivacaine, ropivacaine deliver comparable block quality with fewer side effects. Additionally, hyperbaric solutions are more predictable because of their wider distribution in direction of gravity and lower interpatient variability. Recently ropivacaine has been marketed in India as a hyperbaric solution. The effect of 0.75% ropivacaine hyperbaric in comparison to 0.5% bupivacaine hyperbaric is, however is not evaluated much to firmly claim the advantages and disadvantages the drug ( one above the other) |