Comparison the effects of intra-articular sole ropivacaine and combined ketorolac and ropivacain for pain control after knee arthroscopy surgeries in patients referred to Rasul and Firuzgar Hospitals between 2012-2013 years
This study will be performed in order to investigate the effect of multi-model therapy for pain control after surgery. This clinical, randomized and double-blind trial will be conducted on 40 patients who get knee arthroscopy surgery in Rasul and Firuzgar Hospital during the year 2013 and are pleased for participating in this study; these patients do not have any diseases and recently did not use analgesic drugs. According to entrance and exit criteria the patients will be selected and their blood pressure and heart rate will be determined after connecting NIBP monitoring and pulse-oxy meter at operation room. These patients will be divided into two groups by Block Randomization method: 1- sole ropivacaine group, 2- combined ketorolac and ropivacain group. The first consequence including measurement of pain severity after entrance to recovery room and 2, 4, 8, 12, 18, 24 hours after surgery will be evaluated. The second consequence including nausea, vomiting and sedation will be assessed by expert nurses in recovery room and surgery part.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013073014218N1
Registration date:2013-09-20, 1392/06/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Mehdi Masoomshahi
Name of organization / entity
Tehran University of medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4416 6270
Email address
m-masoomshahi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2014-08-23, 1393/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effects of intra-articular sole ropivacaine and combined ketorolac and ropivacain for pain control after knee arthroscopy surgeries in patients referred to Rasul and Firuzgar Hospitals between 2012-2013 years
Public title
the effectiveness of simultaneous use of analgesic drugs for pain control
Purpose
Prevention
Inclusion/Exclusion criteria
Intrance criteria: to be pleased with participating in this study, the ages between 15 to 60 years old, to have knee arthroscopy surgery under general anesthesia
Exit criteria: the history of using analgesics 24 hours before surgery, the history of bleeding or coagulation problems during the last month before surgery, renal and liver failure, severe cardiopulmonary, coagulopathy, morbid obesity (BMI<30 kg/m2), the history of nausea and vomiting after surgery, the history of migraine, the history of problems incidence during and after surgery, incidence of problems 24 hours after surgery which need the interference, known allergy, sensivity and contraindication about the use of opioid and non-opioid analgesics, pregnancy and lactation, the history of drug and alcohol abuse, being not to satisfied for participating in this study
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
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
it does not have
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th floor, Central Organization of Tehran University of Medical Sciences, corner of Ghods St., Keshavarz Ave.
City
Tehran
Postal code
Approval date
2013-08-21, 1392/05/30
Ethics committee reference number
92/D/1086/130
Health conditions studied
1
Description of health condition studied
pain control after arthroscopy surgery
ICD-10 code
Z09.0 - Y4
ICD-10 code description
Z09.0:Follow-up examination after surgery for other conditions،Y45.9: Analgesic, antipyretic and anti-inflammatory drug, unspecified
Primary outcomes
1
Description
Pain
Timepoint
after entrance to recovery room and 2, 4, 8, 12, 18, 24 hours after surgery
Method of measurement
according to VAS (Visual Analog Scale), 0:no pain, 1-3:slight, 4-7:moderate, 8-10:sever
Secondary outcomes
1
Description
nausea, vomiting and sedation
Timepoint
after entrance to recovery room and 2, 4, 8, 12, 18, 24 hours after surgery
Method of measurement
according to nausea and vomiting scale by patient's explaining about his/her symptoms (no nausea and vomiting/nausea/one to two order of nausea and vomiting/ nausea and vomiting more than two orders) - according to Ramsay sedation scale (1:Anxious or restless or both, 2:Cooperative, orientated and tranquil, 3:Responding to commands, 4:Brisk response to stimulus, 5:Sluggish response to stimulus, 6:No response to stimulus)
Intervention groups
1
Description
In Control group 150 mg of ropivacain soluted in salin 0.9% will be infused inta-articularly by arthroscope at the end of arthroscopy surgery
Category
Treatment - Drugs
2
Description
In treatment group combination of 30 mg ketorolacand 150 mg ropivacain soluted in salin 0.9% will be infused inta-articularly by arthroscope at the end of arthroscopy surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasul Akram Hospital
Full name of responsible person
Mehdi Masoomshahi (resident of anestesiology)
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Firuzgar Hospital
Full name of responsible person
Mehdi Masoomshahi (resident of anestesiology)
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Faranak Rokhtabnak
Street address
Firuzgar Hospital, Anesthesiology Group
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Masoomshahi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
Rasul Akram Hospital, Anesthesiology group
City
Tehran
Postal code
Phone
+98 21 4416 6270
Fax
+98 21 5557 6772
Email
m-masoomshahi@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Faranak Rokhtabnak
Position
Anesthesiologist
Other areas of specialty/work
Street address
Firuzgar Hospital, Anesthesiology group
City
Tehran
Postal code
Phone
+98 21 8894 2661
Fax
Email
rkhtbnk@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehdi Masoomshahi
Position
Resident of Anesthesiology
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
+98 21 4416 6270
Fax
+98 21 5557 6772
Email
m-masoomshahi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)