| CTRI Number |
CTRI/2023/07/055667 [Registered on: 25/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFECTS OF TWO DRUGS, BUPIVACAINE AND LEVOBUPIVACAINE IN GYNAECOLOGICAL PATIENTS UNDERGOING SPINAL ANAESTHESIA |
|
Scientific Title of Study
|
COMPARISON BETWEEN HYPERBARIC LEVOBUPIVACAINE AND HYPERBARIC BUPIVACAINE IN SUBARACHNOID BLOCK FOR ELECTIVE GYNAECOLOGICAL SURGERIES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shinjini Raha |
| Designation |
Post graduate trainee Anaesthesiology |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
244 AJC Bose road,Institute of Post Graduate Medical Education and Research,Department of Anaesthesiology, Kolkata 700020,West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9002743940 |
| Fax |
|
| Email |
shinjini.srijan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Ray |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
244 AJC Bose road,Institute of Post Graduate Medical Education and Research,Department of Anaesthesiology,Kolkata 700020,West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830374904 |
| Fax |
|
| Email |
raymit2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Kumar Ray |
| Designation |
Associate Professor |
| Affiliation |
Institute of Post Graduate Medical Education and Research |
| Address |
244 AJC Bose road,Institute of Post Graduate Medical Education and Research,Department of Anaesthesiology,Kolkata 700020,West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830374904 |
| Fax |
|
| Email |
raymit2005@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology IPGMER,244,AJC Bose Road,Kolkata, West Bengal 700020 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
244 AJC Bose road,Institute of Post Graduate Medical Education and Research,Kolkata 700020,West Bengal |
| 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 |
| Dr Amit Kumar Ray |
IPGMER |
Department of Anaesthesiology, AJC Bose road,Institute of Post Graduate Medical Education and Research,Kolkata 700020,West Bengal
Kolkata
WEST BENGAL |
9830374904
raymit2005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyperbaric bupivacaine |
Dose: 13.5 mg with fentanyl 25 mcg
Frequency: once at the start of surgery
Route: intrathecal
Duration: till patient recovers from the effect of drug |
| Intervention |
Hyperbaric levobupivacaine |
Dose: 13.5 mg with fentanyl 25 mcg
Frequency: once at the start of surgery
Route: intrathecal
Duration: till patient recovers from the effect of drug |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
Patients belonging to ASA I and II |
|
| ExclusionCriteria |
| Details |
Patients with significant cardiac,pulmonary, hepatic or renal disease
Spinal deformities
Abnormal coagulation profile (INR 1.5)
Evidences of skin infections at the site of injection
Disabling neuropsychiatric disorders
Known hypersensitivity to bupivacaine, levobupivacaine or fentanyl
Chronic drug abusers
Alcoholics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the onset of sensory block in both groups
To measure the duration of sensory block in both groups
To measure highest level of sensory block in both groups
To measure the onset of motor block in both groups
To measure the duration of motor block in both groups
To find out the changes in heart rate & mean arterial blood pressure during the course of spinal anaesthesia |
Every three minutes interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare if hyperbaric levobupivacaine is a safer alternative to hyperbaric bupivacaine for elective gynaecological surgeries in subarachnoid block |
After completion of surgery, wearing of effects of spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="142"
Sample Size from India="142"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/08/2023 |
| 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="0"
Days="0" |
|
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
|
One hundred and forty two participants aged 18 years and above to be taken in randomized controlled trial to see if hyperbaric levobupivacaine can be a safer alternative to hyperbaric bupivacaine for elective gynaecological surgeries in subarachnoid block. |