Protocol summary

Summary
Sixty patients with ASA class I and II, 20-80 years who will candidate for esophagus cancer with Transhiatal method surgery, randomly divided into two groups of 30: The F group = Trans-dermal Fentanyl patch and the M group = intravenous morphine An exclusion criterion is patients who have history of allergy to narcotics. The anesthetic method is the same in both groups. In Fentanyl group (F), a Trans-dermal Fentanyl patch 50µg/h will administer one hour prior to anesthesia induction on anterolateral skin of the thorax. In M group, after the operation, 4 mg of morphine will inject every 6 hours. After tracheotomy, the patients is transfer to ICU and their entrance time to ICU is consider as the time zero and they will monitor for 72 hours afterwards. Pain score of the patients will record throughout the next 72 hours after thoracotomy in o, 2, 4, 6 and every 6 hours afterwards and a minute prior to morphine injection. The pain score evaluate by using visual analogue scale, (0-10 number). In case of need for adequate analgesia, with a VAS more than 4, 4 mg of intravenous morphine will inject in both groups. At the end of the study we compare the mean amount of morphine and VAS in the two groups. We will record Vital signs such as systolic, Diastolic blood pressure, heart rate, respiratory rate every 6 hours in the ICU. We will record demographic data such as age, sex, weight and duration of surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110107752N1
Registration date: 2012-03-17, 1390/12/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Parviz Amri Maleh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
pamrimaleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of research Babol university of Medical Sciences
Expected recruitment start date
2012-02-07, 1390/11/18
Expected recruitment end date
2013-02-06, 1391/11/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of trans-dermal fentanyl patch on postoperative pain of esophagus cancer with transhiatal method surgery
Public title
Effectiveness of trans- dermal fentanyl patch on postoperative pain of esophagus cancer surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Elective esophagus cancer surgery; patients with ASA class I and II; transhiatal method surgery; general Anesthesia; The age range 20 to 80 years old. Exclusion criteria :History of allergies to opioid; any contraindication for trans-dermal Fentanyl patch and morphine; addiction to alcohol or narcotics; dementia ; psychological disorders ; skin diseases preventing the administration of TFP; pregnant ; breast-feeding mothers.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Vice-chancellor of research of Babol University of Medical Sciences
Street address
Gangafrooz St, Babol University of Medical Sciences
City
Babol
Postal code
4717641367
Approval date
2012-02-07, 1390/11/18
Ethics committee reference number
5720/30/ژ/پ

Health conditions studied

1

Description of health condition studied
oesophagus cancer
ICD-10 code
C15.9
ICD-10 code description
Oesophagus, unspecified

Primary outcomes

1

Description
postoperative paine
Timepoint
72 h after intervention
Method of measurement
visual analog scale

Secondary outcomes

1

Description
respiration
Timepoint
72 h
Method of measurement
Resoiratory rate per minute

2

Description
systolic blood pressure
Timepoint
72 h postoperation
Method of measurement
mm/Hg

3

Description
diastolic blood pressure
Timepoint
72 h postoperation
Method of measurement
mm/Hg

4

Description
mean amount of morphine
Timepoint
72 h postoperation
Method of measurement
miligram

Intervention groups

1

Description
In intervention group: A patch of 50µg/h Fentanyl was administered on antrolateral of chest wallone hour prior to anesthesia .
Category
Treatment - Drugs

2

Description
In control group:After operation 4 mg of IV morphinewas injected every 6 hours .
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Rohani Hospital
Full name of responsible person
Amrimaleh. Parviz
Street address
Gangafrooz Str, Ayatollah Rohani Hospital
City
Babol

2

Recruitment center
Name of recruitment center
Shahid Behshti Hospital
Full name of responsible person
Nikbakhsh, MD.
Street address
Ganafrooz St, Shahid Behshti Hospital
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor of research, Babol University of Medical Sciences
Full name of responsible person
Mostafazadeh, Amrolah
Street address
Gangafrooz St, Babol University of Medical sciences
City
Babol
Grant name
Grant code / Reference number
714578
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of research, Babol 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
Babol University of Medical Sciences
Full name of responsible person
Amrimaleh,Parviz
Position
Anestesiologist,FCCM
Other areas of specialty/work
Street address
Gangafrooz St, Rohani teaching Hospital
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
pamrimaleh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol Univercity of Medical Sciences
Full name of responsible person
Amrimaleh,Parviz
Position
Anestesiologist,FCCM
Other areas of specialty/work
Street address
Gangafrooz St, Rohani teaching Hospital
City
Babol
Postal code
4717641367
Phone
+98 11 1223 8296
Fax
Email
pamrimaleh@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Amri,Parviz
Position
Anestesiologist,FCCM
Other areas of specialty/work
Street address
Gangafrooz St, Babol University of Medical Sciences
City
Babol
Postal code
47176
Phone
+98 11 1219 9591
Fax
Email
pamrimaleh@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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