| CTRI Number |
CTRI/2022/05/042619 [Registered on: 18/05/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparative study of two spinal anaesthetic drug ie Bupivacaine(0.5%) with fentanyl and chloroprocaine with fentanyl in day care perianal surgeries for faster block resolution and early ambulation and early discharge from the hospital |
|
Scientific Title of Study
|
“EFFECTIVENESS OF INTRATHECAL BUPIVACAINE (0.5%) WITH FENTANYL AND CHLOROPROCAINE (1%) WITH FENTANYL IN DAY CARE PERIANAL SURGERY: A PROSPECTIVE STUDY.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh kumar |
| Designation |
Associate professor |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department of anaesthesiology
Dr BR Ambedkar medical college and hospital Bangalore
Kadugondanahalli ,Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh kumar |
| Designation |
Associate professor |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department of anaesthesiology
Dr BR Ambedkar medical college and hospital Bangalore
Kadugondanahalli ,Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
9845785715 |
| Fax |
|
| Email |
drsantoshkumarcc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harshithkumar M |
| Designation |
Junior resident |
| Affiliation |
Dr B R Ambedkar Medical College and Hospital |
| Address |
Department of anaesthesiology
Dr BR Ambedkar medical college and hospital Bangalore
Kadugondanahalli ,Bangalore
Bangalore
KARNATAKA
560045
India |
| Phone |
7019190230 |
| Fax |
|
| Email |
drharshith43@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical college and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Santosh Kumar |
| Address |
Dr B R Ambedkar medical College and Hospital |
| 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 Santoshkumar |
DR B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
Department of Anaesthesiology
Operation theatre complex
1st floor
Bangalore
KARNATAKA |
9845785715
drsantoshkumarcc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTION ETHICS COMMITTEE |
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 |
Bupivacaine with fentanyl |
Administration of INTRATHECAL BUPIVACAINE (0.5%) WITH FENTANYL AND CHLOROPROCAINE (1%) WITH FENTANYL IN DAY CARE PERIANAL SURGERY |
| Comparator Agent |
chloroprocaine with fentanyl |
Administration of INTRATHECAL BUPIVACAINE (0.5%) WITH FENTANYL AND CHLOROPROCAINE (1%) WITH FENTANYL IN DAY CARE PERIANAL SURGERY |
| Intervention |
Lumbar puncture |
Administration of INTRATHECAL BUPIVACAINE (0.5%) WITH FENTANYL AND CHLOROPROCAINE (1%) WITH FENTANYL IN DAY CARE PERIANAL SURGERY |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to give consent for spinal anaesthesia and
to participate in the study.
2.Patients who has H/o coagulation and bleeding disorders.
3.Local site infections.
4.H/o hypersensitivity to study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of intrathecal bupivacaine (0.5%) with fentanyl and chloroprocaine (1%) with fentanyl in day care perianal surgery for faster block resolution and earlier hospital discharge in day care perianal surgeries, without compromising the safety of the patients. |
From time of giving spinal anaesthesia till 4 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/05/2022 |
| 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 Yet Recruiting |
| 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 study the Effectiveness of intrathecal
bupivacaine (0.5%) with fentanyl and chloroprocaine (1%) with fentanyl in day
care perianal surgery for faster block resolution and earlier hospital discharge
in day care perianal surgeries, without compromising the safety of the
patients ,Prospective observational study is done on 60 elegible patients undergoing perianal surgeries under spinal anaesthesia in Dr B R Ambedkar Medical College and Hospital ,Bangalore. |