Protocol summary

Summary
Post operative pain management in thoracic surgery is necessary to avoid complications. In some cases that have no possibility of epidural catheter insertion, it is extremely important to determine other effective regional methods according the origin of acute pain to prevent post operative pain. Therefore, comparative effectiveness of Epidural, Intrapleural, sub pleural and incisional catheter insertion can evaluate quality and quantity of pain control, complications and drug consumption to introduce the appropriate methods for pain control after lateral Thoracotomy. Numbers of samples (120 patients) are randomly divided into equal four groups. In group (A) epidural catheter at the level of 6 T -8T is placed and 10mililitter bupivacaine 0.25% as bolus dose administered. Induction of anesthesia with Fentanyl, Midazolam, Propofol, Cisatracurium is performed. Maintenance with Propofol and Remifentanyl (TIVA) continued. At the end of surgery muscle relaxant reversed and patients extubeted. Then catheter attached to the Autofuser pump by rate of 2 milliliter per hours Bupivacaine 0.25% infusion. After awaking, the patient transferred to the ICU .Pain score and Opioid (Morphine or Pettedin) needs are recorded since 2 - 6 - 12 - 24 and 48 hours in post operative period. In group (B), instead of epidural catheter, sub pleural (Para Vertebral) catheter is placed at the level of (6T-8T) and 10 milliliter bupivacaine 0.25 % as bolus is injected. Induction and maintenance of Anesthesia are the same; at the end of surgery muscle relaxant reversed and patient extubeted. Then catheter attached to the Autofuser pump by the same rate infusion. After awaking, recording protocol is the same above. In group C catheter located within the pleura (special technique) at the level of (6T-8T) and 10 milliliter Bupivacaine 0.25 % as bolus injected. Induction and maintenance of Anesthesia are the same; at the end of surgery muscle relaxant reversed and patient are extubeted. Then catheter attached to the Autofuser pump by the same rate infusion. After awaking, recording protocol is the same above. In group D, Bupivacaine 0.25% (10 milliliter) infiltrated to the site of surgery before incision then Induction and maintenance of Anesthesia is performed as the same above, at the end of surgery incisinal catheter is placed by surgeon then sutured and dressed. At last catheter attached to the Autofuser pump by the same rate infusion. After awaking, recording protocol is the same above. After collecting information, for parametric data; Independent T-test and for non parametric data; Mann-Whitney chi - square and Fisher exact test, analysis will be used.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201012021772N4
Registration date: 2011-01-01, 1389/10/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-01-01, 1389/10/11
Registrant information
Name
Dawood Aghamohammadi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1381 8940
Email address
aghamohammadid@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2010-12-22, 1389/10/01
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Epidural, Sub pleural, Inter pleural and Incisional catheter placement on post Lateral thorachotoy pain control
Public title
post operative pain control
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria 1-ASA II-III 2-20-60 years of old 3-needs lateral thoracotomy Exclusion Criteria 1- couaglopathy 2-drug sensitivity 3-patients avoidance 4-addiction 5-bilateral thoracotomy 6-operation time more than 3 hours 7-EF less than 40% 8-transfusion more than 4 unit 9- FEV less than 1L 10-history of previous thoracotomy
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
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
Research Ethics committee of Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Daneshghah Street- Tabriz university- red bilding
City
Tabriz
Postal code
Approval date
2010-11-27, 1389/09/06
Ethics committee reference number
8938

Health conditions studied

1

Description of health condition studied
Thoracotomy
ICD-10 code
C34
ICD-10 code description
Malignant neoplasm of bronchus and lung

Primary outcomes

1

Description
pain
Timepoint
2-6-12-24-48 hour
Method of measurement
Visual Analuoge Scale

Secondary outcomes

1

Description
total analgesic dose
Timepoint
2-6-12-24-48 hour
Method of measurement
adding together all analgesics recieved

Intervention groups

1

Description
ٍEpidural catheter implacement
Category
Treatment - Surgery

2

Description
Subplural catheter implacement
Category
Treatment - Surgery

3

Description
Intraplural catheter implacement
Category
Treatment - Surgery

4

Description
Insicinal catheter implacement
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street Imam Reza Hospital- operation room- anesthesia Dept
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dawood Aghamohammadi
Street address
Daneshghah street Imam Reaz Hospital - operation room-anesthesia Dept
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, 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
Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital - operation room - anesthesia Dept
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir daghamohamadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshghah street Imam Reza Hospital -operation room- anesthesia Dept
City
Tabriz
Postal code
Phone
+98 41 1381 8940
Fax
Email
aghamohammadid@tbzmed.ac.ir: daghamohamadi@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
Dr. Dawood Aghamohammadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Daneshghah street Imam reza Hospital - operation room - anesthesia Dept
City
Tabriz
Postal code
Phone
+98 411347054
Fax
Email
aghamohammadid@tbzmed.ac.ir daghamohamadi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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