Comparison effect of local subcutaneous tramadol and methadone in post laparatomy pain control
Design
A total of 60 patients were selected according to entry and exit criteria and the patients were randomly assigned to one of two groups of 30.
Settings and conduct
After patients selection, they will be randomly allocated to tramadol or methadone groups.Before scrubbing the skin and after closing the fascia, 100 mg tramadol in 10 cc normal saline or 70 μg/kg methadone in 10 cc normal saline will be injected around the wound. The severity of pain in patients 1, 6, 12, 18 and 24 hours after laparotomy was assessed using Visual analogue scales and noun phrases criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients undergoing elective laparotomy with general anesthesia, Patients who do not have Epidural catheter, received no analgesics 6 hours prior to surgery. Exclusion criteria: Pregnancy, Diabetes or chronic kidney, liver or heart disease, previous laparotomy, opium addiction, psychological disease or chronic pain disorders.
Intervention groups
In tramadol group, 100 mg diluted tramadol and in methadone group, 70 microgram per kg methadone diluted in 10 cc normal saline, will be injected around the wound.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120605009948N3
Registration date:2018-09-19, 1397/06/28
Registration timing:retrospective
Last update:2018-09-19, 1397/06/28
Update count:0
Registration date
2018-09-19, 1397/06/28
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
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2016-11-21, 1395/09/01
Actual recruitment end date
2017-11-22, 1396/09/01
Trial completion date
2018-05-21, 1397/02/31
Scientific title
Comparison effect of local subcutaneous tramadol and methadone in post laparatomy pain control
Public title
subcutaneous tramadol and methadone in post laparatomy pain control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Patients who are electively underwent laparotomy.
• Patients undergoing general anesthesia.
• Patients with no Epidural catheter.
•Do not use analgesic at least 6 hours before surgery
Exclusion criteria:
Pregnancy
Having Diabetes mellitus or chronic renal, liver or heart disease
Previous laparatomy
Opium addiction
Chronic psychological disease
Chronic pain disorders
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are simply randomized to two experimental groups (methadone or Tramadol) through random number table; received a special code and are treated with own group treatment.
Blinding (investigator's opinion)
Not 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 Sciences
Street address
Tabriz daneshgah av.,Tabriz University of Medical Sciences. anasthesiology department
City
Tabriz
Province
East Azarbaijan
Postal code
١٤٧٦٦-٥١٦٦٦
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.TBZMED.REC.1397.088
Health conditions studied
1
Description of health condition studied
Upper abdominal laparotomy
ICD-10 code
S30
ICD-10 code description
Superficial injury of abdomen, lower back, pelvis and external genitals
Primary outcomes
1
Description
Intensity of pain
Timepoint
1 hours after surgery, 6 hours after surgery, 12 hours after surgery, 18 hours after surgery and 24 hours after surgery
Method of measurement
Using VAS and NPS criteria
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tramadol (100 mg of tramadol diluted with normal saline to 10 cc)
Category
Treatment - Drugs
2
Description
Control group: Methadone (Methadone at a dose of 70 μg / kg diluted with normal saline to 10 cc)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Mostafa Hojaty
Street address
Tabriz University of medical science
City
tabriz
Province
East Azarbaijan
Postal code
1476651666
Phone
+98 41 3334 1994
Email
montazer55@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Street address
Thorax ward, Imam Reza Hospital, Tabriz Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
1476651666
Phone
+98 41 3334 7054
Email
montazer55@yahoo.com
Grant name
Grant code / Reference number
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mostafa Hojaty
Position
Resident of General Surgery
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Golgasht Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 1994
Email
hojatmo@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Position
General Toracic Subspeciality,Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golgasht Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
1476651666
Phone
+98 41 3334 7054
Email
montazer55@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer Bavil Oliaii M.D
Position
General Toracic Subspeciality
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Golgasht Ave.,
City
Tabriz
Province
East Azarbaijan
Postal code
1476651666
Phone
+98 41 3334 7054
Email
montazer55@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available