This study aims to investigate severity( rate) of pain after thoracotomy with two different surgical techniques and is performed on 134 patients with thoracotomy indication in 2015. Patients are randomized into two groups using sealed envelopes. The first 67 patients are their chests closed with pericostal sutures (stitches are placed on top of the fifth rib and on top of the seventh rib), and the next 67 patients are their chest closed with intracostal sutures (stitches will place on top of the fifth rib and through the small holes drilled in the bed of the sixth rib). Pain severity after thoracotomy is evaluated by numeric pain rating scale during 3 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080323480N1
Registration date:2016-02-09, 1394/11/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-09, 1394/11/20
Registrant information
Name
mohsen eshraghi
Name of organization / entity
Qom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 759 9489
Email address
meshraghi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Qom University of Medical Sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination the severity (rate) of pain after closing thoracotomy incision by intracostal sutures and pericostal sutures
Public title
Two different surgical techniques to close thoracotomy incision to decrease the pain after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with thoracotomy indication.
The exclusion criteria: patients younger than 19 years and older than 100 years; chronic pain; long-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) or analgesics; psychiatric illness; cancer invasion into the chest wall; preoperative chest radiation or chemotherapy; previous ipsilateral thoracotomy; neurological diseases such as diabetes-related neuropathy; a history of a previous ipsilateral thoracotomy; rib fracture during surgery; incision infection or empyema; loss of consciousness; mechanical ventilator assistance; pulmonary embolism; reoperation and Patients unwillingness to continue the trial.
Age
From 19 years old to 100 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
134
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Closed envelops
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
Qom University of Medical Sciences, Saheli Street
City
Qom
Postal code
Approval date
2015-02-04, 1393/11/15
Ethics committee reference number
ir.muq.rec.1393.100
Health conditions studied
1
Description of health condition studied
injury of intercostal nerves
ICD-10 code
S24.5
ICD-10 code description
injury of other nerves of thorax
Primary outcomes
1
Description
pain
Timepoint
3 days after surgery
Method of measurement
numeric pain rating score
Secondary outcomes
1
Description
Air lea; hemorrahge; pneumonia; emboli and DVT; empyema; wound infection; atelectasis.
Timepoint
every day after surgery
Method of measurement
physical examination and history taking; CXRay
Intervention groups
1
Description
Intervention group 1: patients are their chests closed with pericostal sutures (stitches are placed on top of the fifth rib and on top of the seventh rib).
Category
Prevention
2
Description
Intervention group 2: patients are their chest closed with intracostal sutures (stitches will place on top of the fifth rib and through the small holes drilled in the bed of the sixth rib).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Mohsen Eshraghi
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Qom 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
Qom University of Medical Sciences
Full name of responsible person
Mohammad Hossein Ghasem Begloo
Position
Medical student
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd
City
Qom
Postal code
Phone
+98 25 3612 2000
Fax
Email
mghasembegloo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mohsen Eshraghi
Position
General Thoracic Subspeciality
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd
City
Qom
Postal code
Phone
+98 25 3612 2000
Fax
Email
mohseneshraghi@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Mohsen Eshraghi
Position
General Thoracic Subspeciality
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd
City
Qom
Postal code
Phone
+98 25 3612 2000
Fax
Email
mohseneshraghi@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)