Determining the effectiveness of intrapleural pethidine on postoperative pain in patients undergoing chest tubing
Design
A clinical trial study with an intervention group (receiving pethidine intrapleural) and a control group (without drug) which is a randomized controlled study without blinding in 2 groups of 29 people using random blocks.
Settings and conduct
The study was performed on 58 patients in need of surgery with chest tube in Qazvin city hospital in 1400. Patients are divided into two groups receiving pethidine or the control group. The amount of pain based on VAS in the first hours, 6, 12, 18 and 24 hours after surgery in both groups is determined and compared. In this study, blindness was not performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Perform surgery with chest tube insertion
Exclusion criteria: pethidine allergy, drug addiction
Intervention groups
Intrapleural pethidine intake ؛ not receiving pethidine
Main outcome variables
The effectiveness of intraploral pethidine on pain intensity and infection rate in hospitalized patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210825052291N1
Registration date:2021-11-23, 1400/09/02
Registration timing:prospective
Last update:2021-11-23, 1400/09/02
Update count:0
Registration date
2021-11-23, 1400/09/02
Registrant information
Name
Mohammad Darvishvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3379 0627
Email address
nafis.rastgoo.20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Analgesic effects of intrapleural pethedine after operations with chest tube insertion
Public title
Analgesic effects of intrapleural pethedine after operations with chest tube insertion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Perform the operation with a chest tube
Exclusion criteria:
Allergy to pethidine
Drug addiction
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups a and b using the balance block randomization method. The size of each block is 4.Balanced randomization method for participants in the clinical trial study is a randomized control, the effect of intrapleural injection of pethidine (group a) and no injection (group b) in reducing pain after chest tubing. Random allocation tool is software.
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 Qazvin University of Medical Sciences
The first hours, 6, 12, 18 and 24 hours after surgery
Method of measurement
visual analogue scale
Secondary outcomes
1
Description
infection
Timepoint
The first hours, 6, 12, 18 and 24 hours after surgery
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Intraploral pethidine injection (injection of pethidine locally into the intraploral space between the parietal and visceral pleura through a catheter causes regional analgesia of the chest).Each injection of 25 mg for 2 minutes from a pethidine vial is given to the patient locally. The patient's vital signs are constantly monitored during the injection.
Category
Treatment - Drugs
2
Description
Control group: Control group, no injection of pethidine (in this group, pethidine is not used, only local anesthetics are used, which are prescribed in the same amount in the intervention group).
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Darvishvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Vellayat Hospital,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0627
Fax
Email
nafis.rastgoo.20@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Darvishvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Vellayat Hospital,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0627
Fax
Email
nafis.rastgoo.20@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Darvishvand
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Vellayat Hospital,Qazvin
City
Qazvin
Province
Qazvin
Postal code
3471976161
Phone
+98 28 3379 0627
Fax
Email
nafis.rastgoo.20@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data can be shared after individuals are unidentified.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any kind of analysis on the delivered data is allowed. Send a message to the author's email to request access to data or documentation.
From where data/document is obtainable
Refer to the email of Dr. Mohammad Darvishvand
What processes are involved for a request to access data/document
After the publication of the article, the applicant is able to access the information by sending an email to the author and its duration is about one month.