| CTRI Number |
CTRI/2022/08/045027 [Registered on: 29/08/2022] Trial Registered Prospectively |
| Last Modified On: |
27/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative randomized clinical study on low dose levobupivacaine for spinal anaesthesia for short surgical laproscopic procedures |
|
Scientific Title of Study
|
A comparative randomized clinical study on Selective Spinal Anaesthesia using hypobaric low dose levobupivacaine without and with 25mcg fentanyl for short laparoscopic procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr RANGALAKSHMI |
| Designation |
HOD, DEPARTMENT OF ANAESTHESIA, RRMCH |
| Affiliation |
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL |
| Address |
Rajarajeswari medical college and hospital, 2 floor , Ot complex 202,MYSORE ROAD, KENGERI SATTELITE TOWN,KAMBIPURA, KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9901703030 |
| Fax |
|
| Email |
rangbharat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SOWMYA MJ |
| Designation |
PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL |
| Address |
Rajarajeswari medical college and hospital, 2floor, Ot complex, hospital building 202,MYSORE ROAD, KENGERI SATTELITE TOWN,KAMBIPURA, KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9880574092 |
| Fax |
|
| Email |
drsowmyamj80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHRUTHI S A |
| Designation |
POST GRADUATE, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL |
| Address |
202,MYSORE ROAD, KENGERI SATTELITE TOWN,KAMBIPURA, KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
7760272962 |
| Fax |
|
| Email |
randomshru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Rajarajeswari medical college and hospital |
| Address |
202,MYSORE ROAD, KENGERI SATTELITE TOWN,KAMBIPURA, KARNATAKA |
| Type of Sponsor |
Private 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 SOWMYA MJ |
RAJARAJESWARI MEDICAL COLLEGE AND HOSPITAL |
2 floor, Ot complex, department of anaesthesia 202,MYSORE ROAD, KENGERI SATTELITE TOWN,KAMBIPURA, KARNATAKA
Bangalore
KARNATAKA |
9880574092
drsowmyamj80@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE RAJARAJESWARI 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 |
| Comparator Agent |
Hypobaric levobupivacaine 15mg |
Local anaesthetic for intrathecal administration. Single shot administration. |
| Comparator Agent |
Hypobaric levobupivacaine 15mg and fentanyl 25mcg |
Local anaesthetic and opioid for intrathecal injection for surgery. Single shot administration. |
| Intervention |
Spinal anaesthesia with levobupivacaine |
Local anaesthetic |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for short duration elective laparoscopic surgeries.
Age 20-60
ASA 1&2
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindications to spinal anaesthesia
ASA 3&4
BMI >40
Hypersensitivity to amide local anaesthetics or fentanyl
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time for unassisted ambulation |
15,30,45 mins post operatively till unassisted ambulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of additional analgesia supplementation intra operatively |
Intraop |
|
|
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)
|
01/09/2022 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A comparative randomized clinical study on Selective Spinal Anaesthesia using hypobaric low dose levobupivacaine without and with 25mcg fentanyl for short laparoscopic procedures |