Comparing the effect of topical Lidocaine-Prilocaine cream and infiltrative Lidocaine on overall pain perception during thoracentesis and abdominocentesis
Study and comparison effect of topical anesthesia by Lidocaine/Prilocaine cream and local infiltrative Lidocaine in reducing pain during thoracentesis and abdominocentesis
Design
parallel, randomized, Clinical trial of 69 patients admitted to Al-Zahra Hospital in Isfahan in 2018 and 2019, for whom the attending physician ordered thoracentesis or abdominocentesis.
Settings and conduct
Interventional Radiology Department of Al-Zahra Hospital
Participants/Inclusion and exclusion criteria
Individuals whose attending physician has ordered a thoracentesis or abdominocentesis.
Comparing the effect of topical Lidocaine-Prilocaine cream and infiltrative Lidocaine on overall pain perception during thoracentesis and abdominocentesis
Public title
Anesthetic effect of topical lidocaine-prilocaine in thoracentesis and abdominocentesis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
patient undergoing thoracentesis or abdominocentesis, ordered by attending physician
Alert
Patients giving their consent to intervention
Exclusion criteria:
being pregnant or breast-feeding
allergies to the amides
having any dermatologic conditions at the site of procedure
being G6PD
using systemic analgesic medications
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Actual sample size reached:
69
Randomization (investigator's opinion)
Randomized
Randomization description
With the help of Random Allocation Software, patients are randomly coded and divided into two groups by these codes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of Isfahan Medical University
Street address
ethics committee of Isfahan Medical University,Hezarjarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.MUI.MED.REC.1397.224
Health conditions studied
1
Description of health condition studied
Pleural effusion
ICD-10 code
J91
ICD-10 code description
Pleural effusion in conditions classified elsewhere
2
Description of health condition studied
Fluid in peritoneal cavity
ICD-10 code
R18
ICD-10 code description
Ascites
Primary outcomes
1
Description
patient pain perception by using 0-10 Numeric Rating Scale
Timepoint
immediately after the procedure
Method of measurement
0-10 Numeric Rating Scale
2
Description
patients’ satisfaction level
Timepoint
immediately after the procedure,after asking pain perception
Method of measurement
1-4 scale
Secondary outcomes
1
Description
number of attempts to perform paracentesis(either abdomonocentesis or thoracentesis)
Timepoint
after the procedure
Method of measurement
Writing down the number of attempts
Intervention groups
1
Description
Intervention group: Lidocaine-Prilocaine cream group received 2.5 gr from Lidocaine-Prilocaine cream. we used cream made by Tehranchemie.CO named Xayla-p. (100gr contain 2.5gr Lidocaine and 2.5gr Prilocaie). 2.5gr From this cream is a 9.5 cm strip of cream.That amount of cream is used to cover 20-25 cm2 around the marked area.After 30 minutes procedure was done.
Category
Rehabilitation
2
Description
Control group: Infiltrative Lidocaine group received 5cc from lidocaine 2%(Caspian Tamin)(100mg) with a 25-gauge needle ,5 minutes before the procedure. Anesthetic is first injected subcutaneously and then deeper close to the parietal pleura in thoracentesis or to the peritoneum in abdominocentesis.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
ALzahra hospital, Isfahan
Full name of responsible person
Reza Azizkhani
Street address
ALzahra hospital,Soffeh Blvd,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University Of Medical Sciences,Hezarjarib Ave, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
international@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Hanieh Halili
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
ALzahra hospital,Soffeh Blvd,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3778 9260
Email
Halili.hanie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Azizkhani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
ALzahra hospital,Soffeh Blvd,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
azizkhani1980@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hanieh Halili
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
ALzahra hospital,Soffeh Blvd,Isfahan,Iran
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3778 9260
Email
Halili.hanie@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
study design, how data was collected, way of analyzing data ,and result of data analysis will be presented as means ± SD, median (largest-smallest), and frequency (percentage of frequency)
When the data will become available and for how long
from the publication date in journal
To whom data/document is available
Who works in medical feilds
Under which criteria data/document could be used
medical doctors, medical nurses
From where data/document is obtainable
refere to the article which will be published .for more information they can contact Hanieh Halili (halili.hanie@yahoo.com) and Reza Azizkhani(azizkhani1980@gmail.com).
What processes are involved for a request to access data/document
from the publication date in journal they can refer to the journal for result of the study.