Protocol summary

Summary
It was a double blind clinical trial which conducted on 40 ASA I, II patients who were candidate for knee arthroscopy in Imam Reza Hospital, Kermanshah, Iran. Patients' age range was 18-60 years. They were divided into 4 groups randomly. Patients in all groups received 20cc of Bupivacaine 0.5% and then 0, 5, 10 and 15 mg of morphine were injected in groups 1, 2, 3 and 4 respectively (group 1 was the control group). Visual Analogue Scale (VAS) was used to identify pain severity within 1, 2, 4, 6 & 24 hours after the operation. Pain relief duration & patients' nausea were evaluated for 24 hours.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138902172946N3
Registration date: 2010-06-28, 1389/04/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-06-28, 1389/04/07
Registrant information
Name
Mitra Yari
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 6310
Email address
myari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medica Sciences
Expected recruitment start date
2009-04-15, 1388/01/26
Expected recruitment end date
2010-04-15, 1389/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of post arthroscopic pain relief by adding morphine to intra articular bupivacain injection
Public title
Effect of adding morphine to intra articular bupivacain on pain relief after arthroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA I, II who were candidate for arthroscopy with age range of 18-60 years. Exclusion criteria: addict patients, pregnant women, patients with history of heart disease and hypertension.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Kermanshah University of Medical Sciences
Street address
#2 building of medical university, Shahid beheshti boulevard
City
Kermanshah
Postal code
6714415333
Approval date
2009-04-10, 1388/01/21
Ethics committee reference number
20/J/13130/43

Health conditions studied

1

Description of health condition studied
local anesthesia in artheroscopy
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
patient's analgesia
Timepoint
within 1, 2, 4, 6 & 24 hours after the operation
Method of measurement
visual analogue scale (VAS)

Secondary outcomes

1

Description
Patients' Nausea
Timepoint
within 1, 2, 4, 6 & 24 hours after the operation
Method of measurement
visual analogue scale (VAS)

Intervention groups

1

Description
injecting 20cc, Bupivacaine 0.5% (5mg/ml) at the end of operation
Category
Prevention

2

Description
injecting 5cc morphine sulfate 10mg/ml
Category
Prevention

3

Description
injecting 10cc morphine sulfate 10mg/ml
Category
Prevention

4

Description
injecting 15 cc morphine sulfate 10mg/ml
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Dr. Mitra Yari
Street address
Parastar boulevard, Sorkhalijeh
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Imam Reza Hospital, Parastar boulevard, Sorkhalijeh
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitra Yari
Position
assistant professor and anesthesiologist
Other areas of specialty/work
Street address
Imam Reza Hospital, parastar boulevard, sorkhalijeh
City
Kermanshah
Postal code
Phone
+98 83 1433 4157
Fax
Email
myari@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Mitra Yari
Position
Assistant professor and anesthesiologist
Other areas of specialty/work
Street address
Imam Reza Hospital, parastar boulevard, sorkhalijeh, kermanshah
City
Kermanshah
Postal code
6714415333
Phone
+98 83 1433 4157
Fax
Email
myari@kums.ac.ir
Web page address

Person responsible for updating data

Contact

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
Loading...