From April 2012 to April 2013, forty patients who will be admitted for thoracotomy are eligible for this prospective randomized clinical trial.Post thoracotomy pain is evaluated by two different surgical methods. All patients are randomly assigned to one of two groups. The first group, 20 patients will receive protection of the superior intercostal nerve by rising the intercostal muscle flap and intracostal sutures will be placed through drilled holes on the rib over the inferior intercostal nerve. The second group we only use intracostal sutures for closure of thoracotomy incision. Each patient over 19 years old will be included for this study. Chronic pain, failure in surgical technique will result in exclusion from the study. The mean duration of hospital stay is seven days and follow-up will be achieved for all patients. The most commen outcome is painless condition after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206059948N1
Registration date:2012-08-30, 1391/06/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-30, 1391/06/09
Registrant information
Name
Majid Montazer
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8435
Email address
montazerma@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2013-03-21, 1392/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intercostals muscle flap and intracostal sutures versus intracostal sutures alone for decreasing post thoracotomy pain.
Public title
Closer sutures for decreasing post thoracotomy pain by two different surgical technique.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patints with pulmonary and non pulmunary pathology who under gone posterolateral thoractomy
exclusion criteria: Below 19 years old; Chronic pain history; Adiction; Psychologic disorders; Invasion to ribs and parietal pleura; Under steroid treatment<6 mounth; Neoadjuvant therapy pre operation; Brain contusion or under mechanical ventilator; Epidoral catheter unuse; Discharge by chest tube
Age
From 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of medical Science university
Street address
Research centre, Medical college, golgasht ave., Tabriz
City
Tabriz
Postal code
51666-14766
Approval date
2012-05-14, 1391/02/25
Ethics committee reference number
9141
Health conditions studied
1
Description of health condition studied
Injury of other nerves of thorax
ICD-10 code
S24.5
ICD-10 code description
Injury of other nerves of thorax
Primary outcomes
1
Description
Pain
Timepoint
The day of surgery.2th weeks post surgery. 1th,2th,4th,6th month post surgery
Method of measurement
1. visual pain scale 2.numeric rating score
Secondary outcomes
1
Description
Air leak, hemorrahge,pneumonia,emboli & DVT, empyema,wound infection,atelectasia
Timepoint
admission day, 1th,2th, 4th days
Method of measurement
CXRay
Intervention groups
1
Description
In first group intercostal muscle with neurovascular bundle separat from upper rib by cutter or scalpel in opening time and salvage thems from damage by rib retractor and lower rib by drilling in closing.
Category
Prevention
2
Description
In second group neurovascular bundle salvage just in closing time by lower rib drilling .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Shahriar Hashemzadeh M.D
Street address
Thorax ward, Imam Reza Hospital, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sokouti Mohsen MD
Street address
Thorax ward, Imam Reza Hospital, Tabriz
City
Tabriz
Grant name
-
Grant code / Reference number
٠
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Science
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Position
Rezident of thorax surgery
Other areas of specialty/work
Street address
Thorax ward, Imam Reza Hospital, Tabriz
City
Tabriz
Postal code
51666-14766
Phone
+98 41 1334 1705
Fax
+98 41 1334 1705
Email
montazer55@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Shahriar Hashemzadeh M.D
Position
General Toracic Subspeciality
Other areas of specialty/work
Street address
Thorax ward, Imam Reza Hospital, Tabriz
City
Tabriz
Postal code
51666-14766
Phone
+98 41 1334 1705
Fax
+98 41 1334 1705
Email
Montazer55@yahoo.com, Shahriar_90@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Medical University
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Position
Thorax subspecility rezident
Other areas of specialty/work
Street address
Emam Reza Hospital
City
Tariz
Postal code
14766-51666
Phone
+98 41 1334 1705
Fax
+98 41 1334 1705
Email
montazer55@yahoo.com
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)