| CTRI Number |
CTRI/2024/09/073843 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of reduction of pain on propofol injection with lignocaine admixture and pretreatment |
|
Scientific Title of Study
|
Comparison of lignocaine pretreatment with torniquet and lignocaine admixture with propofol in alleviating pain on propofol injection - A randomised clinical trial |
| 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 Fathima Amna P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry |
| Address |
Department of Anesthesiology and Critical Care JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9048445830 |
| Fax |
|
| Email |
fathimaamnap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan V K |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry |
| Address |
Department of Anesthesiology and Critical Care JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9841546265 |
| Fax |
|
| Email |
drmohanvk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fathima Amna P |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research , Puducherry |
| Address |
Department of Anesthesiology and Critical Care JIPMER
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9048445830 |
| Fax |
|
| Email |
fathimaamnap@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry
Puducherry 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohan VK |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Room number 1, Department of Anesthesiology and Critical Care ,2nd floor, Institutive block, Dhanvantari Nagar, Gorimedu, Puducherry - 605006
Pondicherry
PONDICHERRY |
9841546265
drmohanvk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee - Interventional Studies - Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry |
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 |
Lignocaine |
pretreatment with 1% lignocaine with torniquet is used followed by propofol |
| Comparator Agent |
Lignocaine admixture |
Mixing lignocaine to propofol before administration . administering the drug then watch for patient complaining of pain associated with propofol injection for 30 seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
ASA class I, II
Patients undergoing elective surgery under general anaesthesia in whom induction with propofol is planned.
|
|
| ExclusionCriteria |
| Details |
patients with known allergies to Propofol or any of its components
patients planned for rapid sequence induction, pregnant patients.
patients with difficult venous access or thin caliber veins.
Patients on any analgesic medications pre operatively
|
|
|
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 |
| To compare the incidence of pain during propofol injection between pretreatment with lignocaine with tourniquet and lignocaine admixture in alleviating pain on propofol injection using VRS score. |
after 15s of propofol injection or as soon as patient complains of pain |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the Severity of pain on propofol injection between the groups using VRS |
after 15s of propofol injection or as soon as patient complains of pain |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
24/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Patients satisfying
eligibility criteria will be enrolled in the study after obtaining written
informed consent. Standard pre-operative assessment
will be done and will include history of allergies to egg or soya bean.
Premedication will be decided by the anaesthesia team managing the
patient.
All patients will be explained about the grading of pain using the
VRS score.
In the
operation theatre, all standard anesthetic monitors will be connected
(electrocardiogram, non-invasive blood pressure, pulse -oximetry).
An 18 G
intravenous cannula will be secured in the largest dorsal vein of the
non-dominant hand and.
Intravenous infusion fluid will be connected.
Fentanyl 2mics/kg IV will
be given to all patients.
All study drugs will be maintained at room
temperature and used within 30 min after preparation. For group A 1ml NS for
pretreatment , 10ml Propofol and 1 ml lignocaine 2% will be prepared and used .
for group B 1 ml lignocaine 2% for pretreatment , 10 ml propofol and 1 ml NS .
In group A, 2 ml of normal saline will be given through the
injection port, while a torniquet is placed 2 cm above wrist to create stasis and the IV fluid flow is stopped. The stasis
is released after 1 minute Lignocaine admixture by
adding 1 ml of 2% lignocaine to 100mg propofol, as per standard procedure is
given. In group B, 2 ml of 1% Lignocaine will
be given through the injection port, while a torniquet is placed 2 cm above
wrist to create stasis and the IV fluid flow is stopped. The stasis is released
after 1 minute. Propofol 100mg will be mixed with 1 ml of normal saline and
will be used for induction of anaesthesia.
0.5mg/kg of Propofol will be given over 5 seconds through
flowing IV line.
Spontaneous
complaints of pain will be noted. If there are none, after 15 seconds following the injection, patients will be questioned about
the incidence of pain. Patients will be asked to rate the severity of pain
using the Verbal Rating Score for pain. scale. This will be done by another anaesthesiologist who is
unaware of the group assignment of the patient.
After the last recording, further induction will be as
decided by attending anaesthesiologist. |