Objectives:
Comparing Intercostals muscle flap and intracostal sutures with intracostal sutures alone for diminishing post thoracotomy pain
Design:
From April 2012 to April 2015, 96 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.
Setting and Conduct:
The first group, 48 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.
Major Inclusion and Exclusion criteria:
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 common outcome is painless condition after surgery.
Interventions:
First intervention includes protection of the superior intercostal nerve by rising the intercostal muscle flap and second intervention includes only intracostal sutures for closure of thoracotomy incision.
Main outcome measures (variables):
First variable is postoperative pain in patients, and second variable includes postoperative complications such as empyema, wound infection, atelectasis and etc.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122216077N4
Registration date:2016-01-13, 1394/10/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-13, 1394/10/23
Registrant information
Name
Ali Ramouz
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3441 3895
Email address
ali.ramouz@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2015-03-21, 1394/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Intercostals muscle flap and intracostal sutures with intracostal sutures alone for diminishing post thoracotomy pain
Public title
Evaluating two different thoracotomy closure suturing techniques for post thoracotomy pain relief.
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 to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In order to perform randomized patient selection, sealed envelopes method have been used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committe of Tabriz University of Medical Sciences
Street address
Imam Reza hospital, Daneshgah street, Tabriz
City
Tabriz
Postal code
Approval date
2013-12-05, 1392/09/14
Ethics committee reference number
92854
Health conditions studied
1
Description of health condition studied
Intercostal nerve damage
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
Chest X-Ray
Intervention groups
1
Description
Intervention group 1:
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
Control group 2:
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
Dr. Seyed Ziaeddin Rasihashemi
Street address
Imam Reza hospital, Daneshgah street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ziaeddin Rasihashemi
Street address
Imam reza hospital, Daneshgah Street, Tabriz
City
Tabriz
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 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 Sciences
Full name of responsible person
Dr. Seyed Ziaeddin Rasihashemi
Position
Assisstant professor of thoracic surgery
Other areas of specialty/work
Street address
Imam Reza hospital, Daneshgah Street
City
Tabriz
Postal code
Phone
+98 41 3334 1705
Fax
Email
zia.hashemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Position
Assisstant professor of thoracic surgery
Other areas of specialty/work
Street address
Imam Reza hospital, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3334 1705
Fax
Email
Montazer55@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Ramouz
Position
Medical Student
Other areas of specialty/work
Street address
Imam Reza hospital, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3441 3895
Fax
Email
ali.ramouz@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)