After obtaining written informed consent from eligible patients, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, a double-blind prospective, randomized study will be done among patients with elective surgery.
Spinal anesthesia with 12.5 mg Marcaine will done in both groups equally.
Inclusion criteria: the patient's satisfaction; age between 20 and 60 years old.
Exclusion criteria: the lack of patient's satisfaction to spinal anesthesia; history of hypnotics or narcotics throughout 24 hours before the surgery; history of drug abuse, or alcohol- dependency; contraindication of morphin or Ketamine.
Patients will be randomly allocated into three groups according to table of random numbers. Groups "one" and "two" will receive 5 mg of intravenous (IV)mophin with 0.5 mg/kg of (IV)ketamine intra-articular and 5 mg of intravenous (IV)mophin with 0.5 mg/kg of (IV)ketamine peri -articular, respectively. Postoperative pain and needs for analgesics will measured at 1, 2, 4, 6, 12 and 24 hours after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021912531N1
Registration date:2013-07-01, 1392/04/10
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-01, 1392/04/10
Registrant information
Name
Kamran Mahmodi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 0168
Email address
mahmodi.k@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2013-09-01, 1392/06/10
Expected recruitment end date
2014-03-01, 1392/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intra-articular and peri -articular injection of morphine and ketamine compound following arthrotomy surgery
Public title
Comparison of analgesic effect of intra-articular and peri -articular injection of morphine and ketamine compound following arthrotomy surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the patient's satisfaction; age between 20 and 60 years old.
Exclusion criteria: the lack of patient's satisfaction to spinal anesthesia; history of hypnotics or narcotics throughout 24 hours before the surgery; history of drug abuse, or alcohol- dependency; contraindication of morphin or Ketamine.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients are assigned randomly to 2 groups using a computerized allocation schedule for the coded syringes containing the study drugs. After randomization, the coded syringes are prepared by an anesthesiologist not involve in the administration of the drug, patient care and data collection.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
No.12, Chamber Sadaf, Golestan Blvd
City
Ahvaz
Postal code
6135733777
Approval date
2013-04-20, 1392/01/31
Ethics committee reference number
ETH-622
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain
Timepoint
1, 2, 4, 6, 12 and 24 hour after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Opioid Consumption
Timepoint
24 hours after surgery
Method of measurement
Milligrams
Intervention groups
1
Description
Drugs:
1-Ketamine:
Dose: 0.5mg/kg
Number of using: Once
Factory name: Rotexmedica
Manufacturing Country's Name: Germany
Location prescribed: intra-articular
Administration time: 10 minutes before the end of surgery
2- Morphin:
Dose: 0.5 mg
Number of using: Once
Factory name: Daroupakhsh
Manufacturing Country's Name: Iran
Location prescribed: intra-articular
Administration time: 10 minutes before the end of surgery
Category
Treatment - Drugs
2
Description
Drugs:
1-Ketamine:
Dose: 0.5mg/kg
Number of using: Once
Factory name: Rotexmedica
Manufacturing Country's Name: Germany
Location prescribed: peri-articular
Administration time: 10 minutes before the end of surgery
2- Morphin:
Dose: 0.5 mg
Number of using: Once
Factory name: Daroupakhsh
Manufacturing Country's Name: Iran
Location prescribed: peri-articular
Administration time: 10 minutes before the end of surgery