| CTRI Number |
CTRI/2023/05/052154 [Registered on: 01/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of two drugs given in spine area in patients posted for surgery in lower abdomen and lower limbs |
|
Scientific Title of Study
|
Comparative evaluation of intrathecal hyperbaric levobupivacaine and ropivacaine with fentanyl as adjuvant in elective infraumbilical surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Jindal |
| Designation |
Associate Professor |
| Affiliation |
Baba Farid university of Health Sciences Faridkot |
| Address |
Department of Anaesthesiology, Guru Gobind Singh Medical college and Hospital Faridkot
Faridkot PUNJAB 151203 India |
| Phone |
|
| Fax |
|
| Email |
jindalseema77@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Seema Jindal |
| Designation |
Associate Professor |
| Affiliation |
Baba Farid university of Health Sciences Faridkot |
| Address |
Department of Anaesthesiology, Guru Gobind Singh Medical college and Hospital Faridkot
Faridkot PUNJAB 151203 India |
| Phone |
|
| Fax |
|
| Email |
jindalseema77@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prerna |
| Designation |
PG student |
| Affiliation |
Baba Farid university of Health Sciences Faridkot |
| Address |
Department of Anaesthesiology, Guru Gobind Singh Medical college and Hospital Faridkot
Faridkot PUNJAB 151203 India |
| Phone |
|
| Fax |
|
| Email |
prernasingh6261@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital Faridkot |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology, Guru Gobind Singh Medical College and Hospital Faridkot |
| 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 Seema Jindal |
Guru Gobind Singh Medical College and Hospital Faridkot |
Department of anaesthesiology main operation theater complex, 2nd floor Faridkot PUNJAB |
9646050485
jindalseema77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee GGS Medical college and Hospital Faridkot |
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 |
0.5% hyperbaric levobupivacaine and 0.75 % hyperbaric ropivacaine |
3.5 ml of drug containing either levobupivacaine or ropivacaine with fentanyl will be given intrathecal and onset and duration of sensory block will be studied |
| Comparator Agent |
hyperbaric levobupivacaine with fentanyl versus hyperbaric ropivacaine with fentanyl |
in one group patients will receive hyperbaric levobupivacaine and fentanyl. in other group patients will receive hyperbaric ropivacaine with fentanyl in spinal anaesthesia for infraumbilical surgeries |
| Comparator Agent |
In Group 2:- patients will receive hyperbaric ropivacaine with fentanyl |
3.5 ml of drug containing hyperbaric ropivacaine will be given by intrathecal route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiology grade I and II patients scheduled for elective infraumbilical surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. patients with known allergy to any of the study drugs
2. patients with coagulation disorders and on anticoagulants
3. patients with local skin infection or disease
4. patients with previous spine surgery or spine abnormality |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| onset and duration of sensory block |
from time of injection of drug till loss of sensation at T6 dermatome which will be checked every 2 minutes till 20 min and then every 10 min till highest level attained |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset and duration of motor block |
every 5 minutes for 30 minutes and then every 15 minutes till recovery of motor blockade to modified bromage score of zero |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/05/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will be conducted in department of Anaesthesiology, GGS medical college and hospital Faridkot on 100 patients scheduled for infraumbilical surgeries under spinal anaesthesia. The patients will be divided into two groups as under:- Group L- patiens will receive 3.5 ml of drug containing o.5% levobupivacaine and 25 mcg of fentanyl. Group R- patiens will receive 3.5 ml of drug containing o.75% Ropivacaine and 25 mcg of fentanyl. After administration of study drug onset of sensory and motor blockade will be assessed. Segmental sensory level of anaesthesia will be assessed by patient s response to pin prick every 2 min till 20 min and then every 10 min till highest level is achieved. time of onset of sensory block will be noted. Time of sensory block regression will be assessed from maximum block height attained to regression till L1 dermatome. Duration of sensory block is defined as time from intrathecal injection to regression of pin prick sensation to L1 dermatome. Motor block will be assessed every 5 min for 30 min and then every 15 min till recovery of motor blockade to modified bromage score of zero. Time of regression of motor block will be assessed from modified bromage score of 3 to zero. Duration of motor block is defined as time from intrathecal injection to regression of motor block to bromage score of zero.Intraoperative pulse rate, mean arterial blood pressure and oxygen saturation will be recorded every 2 min till 20 min and then every 5 min till end of surgery. Any side effects like nausea, vomiting, pruritis, bradycardia or hypotension will be recorded. In the post operative period the time to first analghesic demand will be noted and patient will be given rescue analgesia in the form of injection diclofenac sodium 1.5 mg/kg IV (intravenous) if VAS >3 and requirement of same will be noted for 24 hours. After completion of study, observations obtained will be tabulated and analysed using appropriate statistical methods. |