| CTRI Number |
CTRI/2023/06/054367 [Registered on: 23/06/2023] Trial Registered Prospectively |
| Last Modified On: |
22/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Study to compare Bupivacaine heavy, Levobupivacaine plain and Levobupivacaine heavy with Fentanyl (opioid) as an add on drug under spinal anesthesia in Prostate surgery. |
|
Scientific Title of Study
|
A comparative study of low dose Bupivacaine 0.5% (heavy), Levobupivacaine 0.5% (plain) and Levobupivacaine 0.5% (heavy) with Fentanyl as an adjuvant in Transurethral Resection of Prostate surgery: A prospective randomized study |
| 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 Sanyukta Paul |
| Designation |
PG Resident |
| Affiliation |
Gajra raja Medical college, Gwalior |
| Address |
Department of Anaesthesiology, 7th floor, 1000 bedded Jayarogya hospital,Gajra raja Medical College, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8827430031 |
| Fax |
|
| Email |
sanyuktasaivikash@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Shende |
| Designation |
Associate Professor |
| Affiliation |
Gajra raja Medical college, Gwalior |
| Address |
Department of Anaesthesiology, 7th floor, 1000 bedded Jayarogya hospital, Gajra raja Medical College, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7566439701 |
| Fax |
|
| Email |
drseema26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Shende |
| Designation |
Associate Professor |
| Affiliation |
Gajra raja Medical college, Gwalior |
| Address |
Department of Anaesthesiology, 7th floor, 1000 bedded Jayarogya hospital,Gajra raja Medical College, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
7566439701 |
| Fax |
|
| Email |
drseema26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Gajra raja Medical College, Gwalior, Madhya Pradesh, 474009 |
|
|
Primary Sponsor
|
| Name |
Dr Sanyukta Paul |
| Address |
Department of Anaesthesiology, Gajra raja Medical College, Gwalior, Madhya Pradesh 474009 |
| 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 |
| DrSanyukta Paul |
Gajraraja Medical College and Jayarogya Hospital, Gwalior |
Department of Anaesthesiology, 7th floor, 1000 bedded Jayarogya hospital, Gajra raja Medical College, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH |
8827430031
sanyuktasaivikash@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gajra raja Medical College, Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N401||Benign prostatic hyperplasia withlower urinary tract symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine 0.5% heavy with Fentanyl |
Bupivacaine 0.5% heavy 1.5 ml with 25 microgram Fentanyl for Transurethral Resection of Prostate surgery under spinal anaesthesia |
| Comparator Agent |
Levobupivacaine 0.5% heavy with Fentanyl |
Levobupivacaine 0.5% heavy 1.5ml with 25 microgram Fentanyl for Transurethral Resection of Prostate surgery under spinal anaesthesia |
| Comparator Agent |
Levobupivacaine 0.5% plain with Fentanyl |
Levobupivacaine 0.5% plain 1.5 ml with 25 microgram Fentanyl for Transurethral Resection of Prostate surgery under spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Patient giving consent to participate in study
Age between 50-75 years
Weight between 45-70 kg
ASA grade I and II
Patient scheduled for TURP surgeries.
|
|
| ExclusionCriteria |
| Details |
Patients not giving consent to participate in the study.
Uncooperative patient
ASA grade III and IV
Patients with respiratory, cardiovascular, renal diseases, obesity.
Neurological disease (multiple sclerosis, symptomatic lumbar herniated disc, spinal stenosis)
Coagulopathy
Patient with known hypersensitivity to local anaesthetic.
Local sepsis or infection
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected prolonged efficacy of Levobupivacaine 0.5% heavy over Bupivacaine 0.5% heavy & Levobupivacaine 0.5% plain |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected lesser side effects & stable hemodynamic profile with Levobupivacaine 0.5% heavy than Bupivacaine 0.5% heavy and Levobupivacaine 0.5% plain |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
03/07/2023 |
| 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 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
|
This is a prospective randomized study comparing low dose intrathecal Levobupicaine 0.5% heavy, Levobupivacaine 0.5% plain and Bupivacaine 0.5% heavy with Fentanyl as an adjuvant in Transurethral resection of prostate surgeries. In this study, we are comparing the onset and duration of motor block and sensory block, to study intraoperative hemodynamics and to study the untoward side effects,if any. |