Acute postoperative pain control in opioid dependent patients is a challenging because of the unpredictability in achieving a satisfactory response to any given dose of opioid.
In this randomized clinical trial 144 opioid dependent patients aging 20-50 years who will be candidate for orthopedic bone surgery under general anesthesia, will be randomly allocated to one of the three parallel groups In the group A, after induction of anesthesia,lidocaine will be started with a bolus 1.5 mg/kg followed by infusion 2 mg/kg per hour up to the end of the surgery and in the group B, Ketamine will be administered as a 0.5mg/kg bolus, followed by an infusion of 0.2 mg/kg per hour up to end of surgery. In the group C, normal saline will be started as a bolus,followed by an infusion up to end of surgery.Postoperative analgesia ,sedation score , postoperative nausea and vomiting ,patients satisfaction and respiratory depression will be recorded.
IRCT registration information
IRCT registration number:IRCT2016070211662N10
Registration date:2016-09-09, 1395/06/19
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Iran (Islamic Republic of)
+98 71 1231 8072
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
Expected recruitment end date
Actual recruitment start date
Actual recruitment end date
Trial completion date
Comparison the effect of intraoperative ketamine and systemic lidocaine on post operative pain management of opioid dependent patients undergoing orthopedic surgeries
Comparison the effect of the intravenous ketamine versus lidocaine in decreasing severity of pain in opioid addicted patients undergoing orthopedic surgeries.
Inclusion criteria: The eligible participants were all opioid dependent patients aging 20-50 years who were candidate for orthopedic bone surgery under general anesthesia.
Exclusion criteria: patients having the history of cardiovascular disorders; seizure disorder; psychiatric disorder; renal or hepatic dysfunction;taking illicit medications; hypersensitivity to local anesthetic drugs; other anesthetic method and ASA class more than III .
From 20 years old to 50 years old
Groups that have been masked
Target sample size:
Randomization (investigator's opinion)
Blinding (investigator's opinion)
Other design features
Name of ethics committee
Shiraz Medical School Research Ethic Committee
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
Ethics committee reference number
Health conditions studied
Description of health condition studied
ICD-10 code description
Every 15 min after patients will become awake in post anesthesia care unit (PACU). During the first 24 h postoperative analgesia will be evaluated every 2 hr for 8 hr then every 4 hr till 24 hr.
Method of measurement
By using Numerical Rating Pain Score (0= No pain,..10= the most severe pain that could imagine)
every 15 minute in PACU (post anesthesia care unit )
Method of measurement
By using sedation scale: 0 = Restless , 1 = Calm, 2 = Sleepy, 3 = Drowsy with response to verbal stimuli , 4 = Drowsy without response to verbal stimuli, 5 = Without response to painfull stimuli