Effects of intra-articular injection of morphine with ketorolac on
Postoperative pain relieve after arthroscopic anterior or posterior cruciate ligament reconstruction
The purpose of this study is to compare the effect of intra-articular injection of ketorolac with morphine on severity of pain in patients after arthroscopic anterior or posterior cruciate ligament reconstruction in Imam Ali hospital in Bojnurd.
Inclusion criteria: 1) Patients with torn anterior or posterior cruciate ligament 2) The patient’s agreement on participating in the study
Exclusion criteria:
1) ASA higher than II 2) Allergy to opioid or local anesthetic 3) cardiovascular disease and hypertension 4) respiratory disease 5) Metabolic disease 6) kidney disease 7) Women during pregnancy and lactation 8) Addiction to drugs, alcohol or cigarettes 9) History of peptic ulcer disease or gastrointestinal bleeding 10) People with mental health or Neurology Problems 11) Use NSAID or opioid drugs in the last 24 hours 12) If did not fall pain with drugs that used in the study.
this double blind study, will be performed on 30 Patients Patients randomly divided into two groups of 15 . In first group 30 milligram ketorolac and in second one 5 milligram morphine is injected into the knee joint.
The severity of pain will be assessed by visual analog scale in 6, 12, 18 and 24 hours after surgery, the scaled mean will be compare in study groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015121625560N1
Registration date:2016-02-20, 1394/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Mohsen Abad
Name of organization / entity
Bojnurd School of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3229 6764
Email address
m.abad@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
North Khorasan University Of Medical Science
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of intra-articular injection of morphine with ketorolac on
Postoperative pain relieve after arthroscopic anterior or posterior cruciate ligament reconstruction
Public title
Effects of intra-articular injection of morphine with ketorolac on Postoperative pain relieve after arthroscopy
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion:1) Patients with torn anterior or posterior cruciate ligament 2) The patient’s agreement on participating in the study
exclusion:1) ASA higher than II
2) Allergy to opioid or local anesthetic
3) cardiovascular disease and hypertension
4) respiratory disease
5) Metabolic disease
6) kidney disease
7) Women during pregnancy and lactation
8) Addiction to drugs, alcohol or cigarettes
9) History of peptic ulcer disease or gastrointestinal bleeding
10) People with mental health or Neurology Problems
11) Use NSAID or opioid drugs in the last 24 hours
12) If did not fall pain with drugs that used in the study
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
North Khorasan University of Medical Sciences
Street address
The Central building of North Khorasan University of Medical Sciences, dolat street, Bojnurd
City
Bojnurd
Postal code
947354176
Approval date
2015-06-07, 1394/03/17
Ethics committee reference number
ir.nkums.rec.1394.2
Health conditions studied
1
Description of health condition studied
Rupture Of Cruciate Ligament
ICD-10 code
S83.7
ICD-10 code description
Injury to multiple structures of knee
Primary outcomes
1
Description
Severity of pain
Timepoint
6, 12, 18 and 24 hours after arthroscopy
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Time of the first dose of analgesics administration.
Timepoint
After surgery finished untile the first dose of analgesics
Method of measurement
Hours
Intervention groups
1
Description
Single dose of 30 mg Ketorolac with 5cc volume will infiltrated intra-articular after intervention
Category
Treatment - Drugs
2
Description
Single dose of 5 mg morphine with 5cc volume will infiltrated intra-articular after intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Hospital
Full name of responsible person
Doctor Abad
Street address
Imam Ali Hospital, Shahriari Street, Bojnurd
City
Bojnurd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research & Technology of North Khorasan University of Medical Sciences