| CTRI Number |
CTRI/2024/03/064335 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This is a comparative study between two local anesthetic drugs; Bupivacaine and Levobupivacaine in surgeries involving anal and peri anal surgeries. |
|
Scientific Title of Study
|
Comparative study between hyperbaric Levobupivacaine and hyperbaric Bupivacaine in saddle block for anal and perianal surgeries: A prospective, randomised double blind 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 SHIVAMBRATA CHAUDHURI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
Department of Anesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office- Kenduadihi, Bankura, Pin - 722102
Bankura
WEST BENGAL
722102
India |
| Phone |
8617830515 |
| Fax |
|
| Email |
schaudhuri846@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR TIRTHA RATAN GHOSH |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
Department of Anesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office- Kenduadihi, Bankura, Pin - 722102
Barddhaman
WEST BENGAL
713206
India |
| Phone |
9231824408 |
| Fax |
|
| Email |
dr.tirthaghosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SAYAK PATRA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
BANKURA SAMMILANI MEDICAL COLLEGE |
| Address |
Department of Anesthesiology, Bankura Sammilani Medical College,Lokepur, Post Office- Kenduadihi, Bankura, Pin - 722102
Bankura
WEST BENGAL
722102
India |
| Phone |
9433273012 |
| Fax |
|
| Email |
sayak.bank@gmail.com |
|
|
Source of Monetary or Material Support
|
| Office to Principal, Bankura Sammilani Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Bankura Sammilani Medical College |
| Address |
Department of Anaesthesiology,Bankura Sammilani Medical College, Kenduadihi, Bankura |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Shivambrata Chaudhuri |
Bankura Sammilani Medical College |
Department of Anesthesiology, Bankura Sammilani Medical College,Lokepur, Pin Code -722102
Bankura
WEST BENGAL |
8617830515
schaudhuri846@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF BANKURA SAMMILANI MEDICAL COLLEGE AND HOSPITAL |
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 |
Saddle block anesthesia for anal and perianal surgeries |
0.5% Hyperbaric Levobupivacaine(1.2ml) at L4-L5 intervertebral space for anal and perianal surgeries by saddle block anesthesia |
| Comparator Agent |
Saddle block anesthesia for anal and perianal surgeries |
0.5% Hyperbaric Bupivacaine(1.2ml) at L4-L5 intervertebral space for anal and perianal surgeries by saddle block anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.American Society of Anaesthesiology I and II
2.Patients undergoing short duration Anal and Perianal Surgeries.
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal.
2.Deformities of vertebral column.
3.Neurological diseases.
4.Coagulopathy.
5.Valvular heart disease.
6.Medically not fit for subarachnoid block anaesthesia due to other causes.
7.Allergy to study drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare time for ready to home discharge criteria.
2.To compare first micturition or voiding time.
|
1.Within 6 hours
2.Within 5 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare between onset and duration of sensory and motor blockade as well as analgesic effect , regression of block, time of first analgesia requirement .
2.To compare adverse effects like nausea, vomiting, PDPH and TNS , Cauda Equina Syndrome.
|
Patient’s hemodynamic profile (like BP, heart
rate, oxygen saturation etc), pain , and adverse
effects will be monitored at base line, just after
giving block then every 15 minutes intra
operatively and every hour postoperatively for 8 hours. |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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 1 |
|
Date of First Enrollment (India)
|
27/03/2024 |
| 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="3"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A prospective , randomized , double blinded comparative study between 0.5% hyperbaric bupivacaine and 0.5% hyperbaric levobupivacaine in saddle type of subarachnoid block for anal and perianal surgeries. Our objective is to compare the first time to micturition , time to unassisted ambulation , hospital discharge rates. This is a hospital based, prospective , randomized , double blind study on cohort of patients posted for elective anal and peri anal surgeries under saddle type of subarachnoid block in general surgery elective operating room of Bankura Sammilani Medical College over the period of 18 months. We are expecting that 0.5% hyperbaric levobupivacaine , in comparison to 0.5% hyperbaric bupivacaine , provides earlier first time to micturition, decreases the time to unassisted ambulation and overall decreases the duration of stay of hospital time. |