The effect of lidocaine spray 10% on the satisfaction of patients under spinal anesthesia.
Design
Clinical trial phase 2 double-blind, placebo-controlled, randomized, with a sample size of 200
Settings and conduct
This study is performed on patients referred to the General Operating Room of Modarres hospital who are candidates for spinal anaesthesia. They are allocated to two groups: A and B. Patients in group A receive 10% lidocaine as local anaesthetic and patients in group II obtain an equivalent volume of normal saline. After 5 minutes, drug is removed from the skin and then the procedure is implemented. Relating to the type of spray, the patient and anesthesiologist and anaesthesia technician do not know the groups except for anesthesiologist responsible for handling the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Indication of spinal anesthesia;
ASA Class 1 (A normal healthy patient);
Addiction to opium.
exclusion criteria:
Skin lesions at the needle insertion site;
Patient dissatisfaction;
Emergency surgeries.
Intervention groups
1-10% spray of lidocaine on the skin of people who are candidates for spinal anaesthesia before spinal needle insertion
2-spray of saline on the skin of people who are candidates for spinal anaesthesia before spinal needle insertion
Main outcome variables
Pain during spinal needle insertion;
Anxiety during spinal needle insertion;
Patient cooperation during spinal needle insertion;
Patient satisfaction with spray use.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130120012203N11
Registration date:2020-01-21, 1398/11/01
Registration timing:retrospective
Last update:2020-01-21, 1398/11/01
Update count:0
Registration date
2020-01-21, 1398/11/01
Registrant information
Name
Niloufar Massoudi
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 26 3250 6961
Email address
nmasoudi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2019-10-22, 1398/07/30
Trial completion date
2019-10-23, 1398/08/01
Scientific title
Evaluation of use of lidocaine spray 10% on satisfaction of patients under spinal anesthesia.
Public title
Effect of using lidocaine spray 10% on satisfaction of patients under spinal anesthesia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Indication of spinal anesthesia
ASA Class 1: A normal healthy patient
Addiction to opium
Exclusion criteria:
Skin lesions at the needle insertion site
Patient dissatisfaction
emergency surgeries
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
200
Actual sample size reached:
200
More than 1 sample in each individual
Actual sample size in each individual:
1
Every person who participates is counted as a sample.
Randomization (investigator's opinion)
Randomized
Randomization description
• Randomization method: Simple randomization
• Randomization Component: Individual
• Randomization instrument: computer-generated random numbers table.
•allocation concealment: concealed in sequentially numbered, the similar canister with lidocaine and normal saline spry reserved by the anesthesiologist in the operating room.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to the similarity of the spray canister, the researcher and the patient are unaware of the type of spray material, but the anesthesiologist who performs the procedure and does not participate in the study knows the type of spray material that is marked with a colored label.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Modares Hospital.,Sadat Abade Blvd
City
Tehran
Province
Tehran
Postal code
1998734383
Approval date
2015-11-02, 1394/08/11
Ethics committee reference number
IR.SBMU.REC.1394.105
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
G89.18
ICD-10 code description
Other acute post procedural pain
Primary outcomes
1
Description
Acute pain
Timepoint
At the end of surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Anxiety
Timepoint
At the end of surgery
Method of measurement
Anxiety with Zank questionnaire
2
Description
Cooperation
Timepoint
At the end of surgery
Method of measurement
The rate of cooperation with the questionnaire
3
Description
satisfaction
Timepoint
At the end of surgery
Method of measurement
Using the questionnaire
Intervention groups
1
Description
Intervention group: The lidocaine spray 10% is scattered 5 minutes before the spinal anesthesia is implemented at the injection site.
Category
Treatment - Drugs
2
Description
Control group: spry normal saline is scattered 5 minutes before the spinal anesthesia is implemented at the injection site.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Modares Hospital
Full name of responsible person
Nilofar Massoudi
Street address
Modarres Hospital., Saddat Abade Blvd., Kaj Square.,
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
massodi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Street address
Modarres Hospital., Saddat Abade Blvd., Kaj Square
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
massodi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Position
Assistance Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital., Saddat Abade Blvd., Kaj Square.,
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
massodi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital., Saddat Abade Blvd., Kaj Square
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
massodi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nilofar Massoudi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital., Saddat Abade Blvd., Kaj Square
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Email
massodi@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about its main consequence, can be shared.
When the data will become available and for how long
The access period will be 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions will be available.
Under which criteria data/document could be used
When using data for further studies such as meta-analysis
From where data/document is obtainable
Dr. Nilofar Massoudi
massodi@sbmu.ac.ir
Modarres Hospital., Saddat Abade Blvd., Kaj Square
+98 21 2207 4087
What processes are involved for a request to access data/document
List the requested information in full identification with email and then email it in response to information other than data that identify patients.