Comparison of the effect of local administration of bupivacaine and dexamethasone combination with bupivacaine administration only in postoperative pain in patients undergoing thoracotomy
Determination of the effect of local administration of bupivacaine and dexamethasone with bupivacaine administration only in postoperative pain in patients undergoing thoracotomy
Design
Clinical trial with control group, double blind, randomized, phase 2-3 on 40 patients. Randomization is done by Randomizer software.
Settings and conduct
This double blind study was done in Amin & Alzahra hospitals (Isfahan, IRAN). Only surgical technologist know which drug is administered. After closing the chest wall in the intervention group, the 2.5 mg of bupivacaine per kilogram of weight is injected with 0.2 mg per weight of dexamethasone in the catheter. In the control group, the 2.5 mg of bupivacaine per kilogram of weight is injected in the catheter. After 6 hours, this amount of drug in the control and intervention groups is injectedin the catheter .
Participants/Inclusion and exclusion criteria
Patients who are candidate for thoracotomy include in the study . In case of allergy to the drugs used, patients will not enter the study.
Intervention groups
Intervention group 1: Local Bupivacaine and dexamethasone. Intervention group 2: Local Bupivacaine only.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220309054226N1
Registration date:2022-03-21, 1401/01/01
Registration timing:registered_while_recruiting
Last update:2022-03-21, 1401/01/01
Update count:0
Registration date
2022-03-21, 1401/01/01
Registrant information
Name
Pouriya Sarboloukzadeh harandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 2020
Email address
dr.pooriasharandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-04-20, 1401/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local administration of bupivacaine and dexamethasone combination with bupivacaine administration only in postoperative pain in patients undergoing thoracotomy
Public title
Comparison of the effect of local administration of bupivacaine and dexamethasone combination with bupivacaine administration only in postoperative pain in patients undergoing thoracotomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidate for thoracotomy
Consent to participate in the study
Exclusion criteria:
History of allergy to the used medications
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization to two groups of 20 people using Randomizer software. This is done by introducing the file number to the software and random allocation order into two groups of 20. This randomization was done by a trained person, but without interference in the research process, and output information is only observed by operating room technicians at the time of operation.
Blinding (investigator's opinion)
Double blinded
Blinding description
Only surgical technicians are aware of the drug(s) that used and the doctor and patient are blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of MedicalSciences and Health Services, Building No. 4
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-02-20, 1400/12/01
Ethics committee reference number
IR.MUI.MED.REC.1400.811
Health conditions studied
1
Description of health condition studied
Acute post-thoracotomy pain
ICD-10 code
G89.12
ICD-10 code description
Acute post-thoracotomy pain
Primary outcomes
1
Description
Acute post-thoracotomy pain
Timepoint
6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Local injection of 2.5 milligram bupivacaine (AuroMedics Pharma LLC, USA) and 0.2 milligram dexamethasone (Caspian Tamin, IRAN) per kilogram of body weight in the subpleural catheter
Category
Treatment - Drugs
2
Description
Control group: Local injection of 2.5 milligram bupivacaine (AuroMedics Pharma LLC, USA)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Pouriya Sarboloukzadeh Harandi
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of Medical Sciences and Health Services, Building No. 4
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
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
Pouriya Sarboloukzadeh Harandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Dr.pooriasharandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pouriya Sarboloukzadeh Harandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Dr.pooriasharandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pouriya Sarboloukzadeh Harandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Dr.pooriasharandi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Information is kept confidential
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is 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
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared
When the data will become available and for how long
After publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to complete studies
From where data/document is obtainable
Dr. Pouriya Sarboloukzadeh Harandi, Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided