| CTRI Number |
CTRI/2024/02/063349 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| 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
|
Randomized comparative study to evaluate safety of levobupivacaine and ropivacaine in patients posted for TURP |
|
Scientific Title of Study
|
A Randomized Comparative Study to Evaluate The Effects and Safety of Intrathecal Hyperbaric Levobupivacaine 0.5% and Hyperbaric Ropivacaine 0.75% In Patients Undergoing Transurethral Resection of Prostate(TURP) Surgery 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 |
Karan Malhotra |
| Designation |
Post graduate |
| Affiliation |
MMIMSR, Mullana |
| Address |
Dept of Anaesthesia
MMIMSR
Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
|
| Fax |
|
| Email |
dashkaran@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sapna Bansal |
| Designation |
Professor |
| Affiliation |
MMIMSR, Mullana |
| Address |
Dept of Anaesthesia
MMIMSR
Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8168381441 |
| Fax |
|
| Email |
drsapna10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sapna Bansal |
| Designation |
Professor |
| Affiliation |
MMIMSR, Mullana |
| Address |
Dept of Anaesthesia
MMIMSR
Mullana, Ambala
Ambala
HARYANA
133207
India |
| Phone |
8168381441 |
| Fax |
|
| Email |
drsapna10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Karan Malhotra |
| Address |
Dept of anaesthesia
MMIMSR,
Mullana, Ambala |
| 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 Karan Malhotra |
MMIMSR, Mullana |
Dept of anaesthesia
OT complex
2nd floor
old building, MMIMSR
Ambala
HARYANA |
9686376074
dashkaran@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MMIMSR |
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 |
| Intervention |
Spinal anaesthesia group A |
Spinal anaesthesia for patient undergoing TURP with hyperbaric LEVOBUPIVACAINE 0.5% with dose of 3ml (15mg) and monitoring of vitals throughout the surgery |
| Comparator Agent |
Spinal anaesthesia group B |
Spinal anaesthesia for patient undergoing TURP with hyperbaric ROPIVACAINE 0.75% 3ml (22.5mg) and monitoring of vitals throughout the surgery |
|
|
Inclusion Criteria
|
| Age From |
0.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Male |
| Details |
ASA 1 and ASA 2 patients posted for TURP |
|
| ExclusionCriteria |
| Details |
1. Negative consent by the patient
2. Contraindication for spinal Anaesthesia (such as coagulopathy, infection at injection site, hypotension, disease or deformity of spine)
3. Psychiatric patient
4. ASA status III/IV
5. Known sensitivity to the drug
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of the study is to evaluate the efficacy in terms of onset and duration of sensory block as primary outcome in two groups: Group 1(L) – 3ml 0.5% hyperbaric levobupivacaine and Group 2(R) – 3ml 0.75% hyperbaric ropivacaine. |
Outcomes will be assessed at baseline, time intervals of 2min upto 10min after administration of spinal anaesthesia with the selected drugs followed by every 5 minutes until completion of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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 Yet Recruiting |
| 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
|
The present prospective,
randomized and double blind study will be conducted in Department of
Anaesthesiology, MMIMSR Mullana Ambala, Haryana. After the approval of protocol
by the Institutional Ethics Committee, and registration with Clinical Trial
Registry India, a total number of 50 ASA I and ASA II status patients scheduled
for elective TURP surgery under spinal anaesthesia will be included in the
study after obtaining informed consent for the study. The effects and efficacy of hyperbaric LEVOBUPIVACAINE 0.5% and hyperbaric ROPIVACAINE 0.75% will be compared. |