Comparison of intercostal nerve block and local anesthesia in tube thoracostomy procedure pain
Design
Two arm parallel group randomised trial without blinding on 64 patients who randomised with random number table
Settings and conduct
Hospitalized patient in Kashan Shahid Beheshti hospital who need thoracostomy randomized in two group. the first group were go under thoracostomy prosedure with local anesthesia and the other group with intercostal nerve block. we use 0.5% Bupivacaine for anesthesia in two groups. Intraoperative and postoperative pain after thoracostomy tube were ducumented and analyzed
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Established pleural effusion , Hemothorax or pneumothorax
Age above 18 and below 75 years old
GCS > 13
Exclusion criteria :
Drug addiction
Traumatic patient
Intervention groups
In first group after intercostal nerve block,thoracostomy tube inserted
in second group after local anesthesia thoracostomy tube inserted
Main outcome variables
Intraoperative and postoperative pain ; Analgesic use in 24 hours after the procedure (Opioid and non-opioid)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200901048584N1
Registration date:2020-12-30, 1399/10/10
Registration timing:registered_while_recruiting
Last update:2020-12-30, 1399/10/10
Update count:0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
mohammad hasan izadian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3461 6213
Email address
izadian_mh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-06-22, 1400/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intercostal nerve block and local anesthesia in tube thoracostomy procedure pain
Public title
Comparison of intercostal nerve block and local anesthesia in tube thoracostomy procedure pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Glascow score > 13
Pleural effusion , Hemothorax or Pneumothorax
Exclusion criteria:
Drug addiction
Opioid analgesics
Trauma patients
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
To select patients for either intercostal or local anesthesia approach,simple randomization method is considered. For the former selected ever numbers and for the latter odd numberes is regarded respectively.
The number would be randomly placed from 01 to 64 in a table. The thoracostomy tube inserting procedure is then identical across the classic approach.
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
Faculty of Medicine & Faculty of Dentistry- Kashan University of Medical Sciences
Street address
Qotbe ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
8715985191
Approval date
2020-07-27, 1399/05/06
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.072
Health conditions studied
1
Description of health condition studied
toracostomy
ICD-10 code
J90
ICD-10 code description
Pleural effusion, not elsewhere classified
Primary outcomes
1
Description
Intraoperative and postoperative pain in thoracostomy insertion
Timepoint
Evaluation of intraoperative pain and postoperative pain in 3 , 6 , 12 , 24 hour after thoracostomy tube insertion
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: Intercostal nerve block performed with totally 15 ml of 0.5% bupivacaine (produced in Astrazeneca company) . intraoperative and postoperative pain evaluate with Visual Analogue Scale .
Category
Other
2
Description
Second Intervention group: Local Anesthesia performed with maximum 35 ml of 0.5% bupivacaine (produced in Astrazeneca company) . intraoperative and postoperative pain evaluate with Visual Analogue Scale
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Mohammad Hasan Izadian
Street address
Qotbe ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5500 5470
Email
mh.izadian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafshe
Street address
Qotbe ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 5500 5454
Email
mh.izadian@gmail.com
Web page address
http://research.kaums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Izadian
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Qotbe ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 3461 6213
Fax
Email
izadian_mh@kaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Izadian
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Qotbe ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 3461 6213
Fax
Email
izadian_mh@kaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Hasan Izadian
Position
General surgery resident
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Qotbe ravandi Blvd.
City
Kashan
Province
Isfehan
Postal code
8715985191
Phone
+98 31 3461 6213
Fax
Email
izadian_mh@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
all collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
this only available for people working in academic institutions
Under which criteria data/document could be used
no criteria
From where data/document is obtainable
Mohammad Hasan Izadian
Mh.izadian@gmail.com
00989138002308
What processes are involved for a request to access data/document