Comparison of Intra-Articular Injection of Ketorolac versus Placebo for Post-Arthroscopic Pain Control in Patients with Knee Ligaments and Menisci injuries
Post operative pain as affected physiological activity may adverse effects on surgery results and control of acute post operative pain can result improvement in patients clinical activity. Non-stroidal anti-inflammatory drugs result in better post operative rehabilitation and early ambulation and improvement in range of motion, by reducing inflammatory responses occurred after operation. In this study, 60 patients with knee ligaments or menisci injuries who admitted since March, 2015 and selected by inclusion and exclusion criteria and randomized. Then, they divided in two groups that each one contains 30 patients. They all treated by arthroscopic surgery. In case group Ketorolac injected in the knee joint immediately after surgery and in control group same volume of normal saline injected. If patients have severe pain in post-operative period, Intravenous opiod drugs would administered, as they wanted.
Sleep disturbance in the first night after surgery and pain severity at 4 hours. 8 hours.12 hours and 24 hours after surgery registered and will be compared between two groups. The study is blinded for cases and researchers.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015040721640N1
Registration date:2015-04-27, 1394/02/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-04-27, 1394/02/07
Registrant information
Name
Abolfazl Mokhtari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3389 3765
Email address
mokhtaria@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Intra-Articular Injection of Ketorolac versus Placebo for Post-Arthroscopic Pain Control in Patients with Knee Ligaments and Menisci injuries
Public title
Intra-Articular Injection of Ketorolac for Post-Arthroscopic Pain Control
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient agreement; No history of cardiac and renal diseases; No history of lower limb fractures; No congenital disorders of extremities; No addiction to opioid. Exclusion criteria: History of regular analgesic and anti-inflammatory drugs; Neuropathies such as diabetes mellitus; Pregnancy; Patient with Coagulopathy; History of Gastro-Intestinal bleeding; History of Ketorolac-related complication or sensitivity
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah avenue
City
Tabriz
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
93187
Health conditions studied
1
Description of health condition studied
Post-operative pain
ICD-10 code
S83.2, S83
ICD-10 code description
Tear of meniscus, Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
Knee Pain
Timepoint
24-hours after surgery
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Sleep disorder
Timepoint
Night after surgery
Method of measurement
Subjective
2
Description
Opioid requirement
Timepoint
24-hours after surgery
Method of measurement
Doses used
Intervention groups
1
Description
Control group: Intra-Articular Injection of Saline
Category
Placebo
2
Description
Intervention group: Intra-Articular Injection of Ketorolac
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Abolfazl Mokhtari
Street address
Emam Reza hospital, Daneshgah avenue
City
Tabriz
2
Recruitment center
Name of recruitment center
Shohada hospital
Full name of responsible person
Abolfazl Mokhtari
Street address
Shohada hospital, Golestan avenue
City
Tabriz
3
Recruitment center
Name of recruitment center
Shahid Ghazi hospital
Full name of responsible person
Abolfazl Mokhtari
Street address
Shahid Ghazi hospital, Daneshgah avenue
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah avenue
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 of 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
Abolfazl Mokhtari
Position
Doctor in Medicine, Orthopedics resident
Other areas of specialty/work
Street address
Shohada hospital, Golestan avenue
City
Tabriz
Postal code
Phone
+98 41 3389 3765
Fax
Email
abolfazlmokhtari@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
Amirmohammad Navali
Position
Doctor in medicine, Orthopedics department
Other areas of specialty/work
Street address
Shahid Ghazi hospital, Daneshgah avenue
City
Tabriz
Postal code
Phone
+98 41 3389 3765
Fax
Email
navali_amir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Abolfazl Mokhtari
Position
Doctor in medicine, Orthopedics resident
Other areas of specialty/work
Street address
Shohada hospital, Golestan avenue
City
Tabriz
Postal code
Phone
+98 41 3389 3765
Fax
Email
abolfazlmokhtari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)