The aim of this research is to compare Buprenorphine with Morphine to relieve pain after the Orthopedic surgery . All patients are candidated for orthopedic surgery (Closed Reduction)and who are Over 18 years of age , if they are satisfied for the study , could be enrolled into this study . The main exclusion criteria are: previous allergy to Buprenorphine and Morphine; addiction to narcotic , alcohol , benzodiazepines ; history of analgesic use in the past 24 hours . This study included patients referred to the Imam Reza hospital in Mashhad . The sample size in each group (Morphine and Buprenorphine) is 45 . To the patients in the Morphine group, 0.2 mg/kg as intravenous Morphine (maximum ten mg) before induction of anesthesia and in the Buprenorphine group, 4.5 mcg/kg Buprenorphine(maximum one mg) as sublingual , 30 minutes before induction of anesthesia will be given . The two groups are under a same general anesthesia and until 12 hours after surgery, the pain and side effects of drugs (nausea - vomiting - itching - urinary retention) are evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012101311102N1
Registration date:2013-07-24, 1392/05/02
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-24, 1392/05/02
Registrant information
Name
Mahmood Khorsand
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 1610 9178
Email address
khorsandm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Finance of Mashhad University of Medical Science( Research Manager)
Expected recruitment start date
2013-08-20, 1392/05/29
Expected recruitment end date
2013-11-20, 1392/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Buprenorphine with Morphine in post-operative pain after orthopedic surgeries.
Public title
Comparison of Buprenorphine with Morphine in post-operative pain after orthopedic surgeries.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Orthopedic surgery(closed reduction-Pinning); Duration of surgery between thirty minutes to one hundred and twenty minutes; Over 18 years of age; ASA class I,II
Exclusion criteria: Previous hypersensitivity to Buprenorphine and Morphine; History of analgesic use in the past 24 hours; Duration of surgery less than thirty minutes and more than one hundred and twenty minutes; Pregnant and lactating women; Addiction to Narcotic or Alcohol or Benzodiazepines.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Fakori Blvd, Mashhad University of Medical Science
City
Mashhad
Postal code
Approval date
2013-02-12, 1391/11/24
Ethics committee reference number
910638
Health conditions studied
1
Description of health condition studied
Orthopedic Surgeries
ICD-10 code
T02.6
ICD-10 code description
Fractures involving multiple regions of upper limb(s) with lower limb(s)
Primary outcomes
1
Description
Postoperative pain
Timepoint
Entry to recovery-30 minutes later-3hours later-6hours later-12hours later
Method of measurement
VAS scale
Secondary outcomes
1
Description
Nausea
Timepoint
Entry to recovery-30 minutes later-3hours later-6hours later-12hours later
Method of measurement
Clinical evaluation and patient complaints
2
Description
Vomiting
Timepoint
Entry to recovery-30 minutes later-3hours later-6hours later-12hours later
Method of measurement
Clinical evaluation and patient complaints
3
Description
Itching
Timepoint
Entry to recovery-30 minutes later-3hours later-6hours later-12hours later
Method of measurement
Clinical evaluation and patient complaints
4
Description
urinary retention
Timepoint
Entry to recovery-30 minutes later-3hours later-6hours later-12hours later
Method of measurement
Clinical evaluation and patient complaints
Intervention groups
1
Description
In the Morphine group , 0.2 mg kg as intravenous Morphine (maximum ten mg) is administered before induction of anesthesia.
Category
Prevention
2
Description
In Buprenorphine group , 4.5 mcg/ kg Buprenorphine (up to a 1 mg)Prescribed as sublingual , half-hour before induction of anesthesia.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Dr. Ghasem Soltani
Street address
Emam Reza hospital, anesthesia group
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences- Deputy for research
Full name of responsible person
Dr. Ghasem Soltani
Street address
Emam Reza hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences- Deputy for research
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
Mashhad University of Medical Science, Emam Reza hospital
Full name of responsible person
Dr. Ghasem Soltani
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesia group, Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2711
Fax
Email
SoltaniGh@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Science, Emam Reza hospital
Full name of responsible person
Dr. Nahid Zirak
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Anesthesia group; Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2711
Fax
Email
ZIRAKN@MUMS.AC.IR
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Science, Emam Reza hospital
Full name of responsible person
Dr. Mahmood Khorsand
Position
Resident of anesthesia
Other areas of specialty/work
Street address
Anesthesia group, Emam Reza hospital
City
Mashhad
Postal code
Phone
+98 51 1802 2711
Fax
Email
khorsandm901@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)