| CTRI Number |
CTRI/2023/05/052486 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| 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 hyperbaric ropivacaine and hyperbaric bupivacaine for spinal anaesthesia in anorectal and urological surgeries |
|
Scientific Title of Study
|
A comparative evaluation of intrathecal 0.5% hyperbaric ropivacaine versus intrathecal 0.5% hyperbaric bupivacaine for anorectal and urological elective surgeries- A randomized comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha T |
| Designation |
postgraduate |
| Affiliation |
sri manakula vinayagar medical college and hospital |
| Address |
no:20,14th cross, avvai nagar,lawspet,puducherry
Pondicherry
PONDICHERRY
605008
India |
| Phone |
9047015196 |
| Fax |
|
| Email |
snehathandapani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh kumar K |
| Designation |
professor |
| Affiliation |
sri manakula vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology
sri manakula vinayagar medical college and hospital
Madagadipet, Kalitheerthalkuppam, Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
|
| Fax |
|
| Email |
surekumk9292@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Suresh kumar K |
| Designation |
professor |
| Affiliation |
sri manakula vinayagar medical college and hospital |
| Address |
Department of Anaesthesiology
sri manakula vinayagar medical college and hospital
Madagadipet, Kalitheerthalkuppam, Puducherry
PONDICHERRY
605107
India |
| Phone |
|
| Fax |
|
| Email |
surekumk9292@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Sneha T |
| Address |
no:20,14th cross, avvai nagar, lawspet, puducherry 605008 |
| 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 |
| Sneha T |
sri manakula vinayagar medical college and hospital |
Department of Anaesthesiology Madagadipet, Kalitheerthalkuppam, Puducherry 605107
Pondicherry
PONDICHERRY |
9047015196
snehathandapani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N471||Phimosis, (2) ICD-10 Condition: N359||Urethral stricture, unspecified, (3) ICD-10 Condition: N20-N23||Urolithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bupivacaine,ropivacaine |
0.5% bupivacaine intrathecal 2cc
0.5% ropivacaine intrathecal 2cc |
| Comparator Agent |
duration of motor blockade (from the time of intrathecal injection to modified bromage score 0 i.e free movement of legs and feet |
modified bromage score. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled to undergo elective anorectal and urological surgeries under spinal anaesthesia
2. Patients of ASA physical status I & II.
3. Patients of either sex.
4. Age >18 years or < 60 years
|
|
| ExclusionCriteria |
| Details |
1. Patients of ASA physical status III and IV
2. Patients with local site infection, allergy to the drugs used
3. Patients who have psychiatric illness, coagulation abnormalities
4. Pregnant / Lactating women.
5. Patients refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) duration of motor blockade
|
1) time from intrathecal injection to modified bromage score 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) onset and duration of sensory block
2) pain assessment |
1) pin prick assessed every minute from 1min to 6 mins and then every 10 mins until two segment regression
2) VAS score postoveratively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2023 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare duration
of motor blockade of hyperbaric bupivacaine and
hyperbaric ropivacaine is the primary objective. Drug having faster regression of the block, adequate for the scheduled surgery and also which has a higher patient satisfaction can be recognised. |