The purpose of this randomized, double-blind clinical trial without placebo is to compare the effect of interpleural bupivacaine and morphine on pain after thoracotomy surgery. In this study, 30 patients undergoing thoracotomy operation between 80-18 years of age who meet the study inclusion and exclusion criteria are randomly assigned in one of the two intervention groups to receive interpleural bupivacaine or morphine during the first 24 hours after surgery؛ and the severity of pain and exact sedation in the two groups will be compared. Major excluding criteria were the amide type local anesthetic allergy؛ sensitivity or contraindicated use of NSAID؛ depresion&other psychotic disorders.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204226392N2
Registration date:2012-06-18, 1391/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-06-18, 1391/03/29
Registrant information
Name
Hamid Reza Vafaei
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0026
Email address
vafaee_h@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2011-10-23, 1390/08/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the analgesic effects of interpleural bupivacaine and morphine for postthoracotomy pain
Public title
The effect of bupivacaine and morphine on pain after thoracotomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients admitted to Shahid Beheshti Kashan hospital for elective thoracotomy aged 18-80 years
Excluding criteria:The amide type local anesthetic allergy؛ sensitivity or contraindicated use of NSAID؛ depresion&other psychotic disorders؛ alcoholism؛ mental retard patients؛ patients with coagulopathy
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics in Medical Research of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences
City
kashan
Postal code
Approval date
2012-03-07, 1390/12/17
Ethics committee reference number
29/5/1/4298/پ
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R07.1
ICD-10 code description
Chest pain on breathing Painful respiration
Primary outcomes
1
Description
pain severity
Timepoint
0-6-12-24 hours after surgery
Method of measurement
FPS (face pain scale)
Secondary outcomes
1
Description
Degree of patient sedation
Timepoint
0-6-12-24 hours after surgery
Method of measurement
SS (sedation score)
Intervention groups
1
Description
interpleural Administration of 0.2 mg/kg morphine sulfate
Category
Treatment - Drugs
2
Description
interpleural Administration of 1 mg/kg bupivacaine% 0.5
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan Shahid Beheshti Hospital
Full name of responsible person
Dr. Hamid Reza Vafaei
Street address
Unit 404, Physicians Complex, Amryh Square, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Vice chancellor for research, Kashan University of Medical Sciences, 5 km polar Ravandi Blvd
City
kashan
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Vafaei
Position
General Surgery Resident
Other areas of specialty/work
Street address
Unit 404, Physicians Complex, Amryh Square, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0029
Fax
Email
vafaee_h@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Vafaei
Position
General Surgery Resident
Other areas of specialty/work
Street address
Unit 404, Physicians Complex, Amryh Square, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0029
Fax
Email
vafaee_h@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Vafaei
Position
General Surgery Resident
Other areas of specialty/work
Street address
Unit 404, Physicians Complex, Amryh Square, Kashan
City
Kashan
Postal code
Phone
+98 36 1555 0029
Fax
Email
vafaee_h@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)