Protocol summary

Summary
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.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070211662N10
Registration date: 2016-09-09, 1395/06/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-09, 1395/06/19
Registrant information
Name
Mohammad Ali Sahmeddini
Name of organization / entity
Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1231 8072
Email address
sahmeddini@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellery of Research and Technology, Shiraz University Of Medical Sciences .
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of intraoperative ketamine and systemic lidocaine on post operative pain management of opioid dependent patients undergoing orthopedic surgeries
Public title
Comparison the effect of the intravenous ketamine versus lidocaine in decreasing severity of pain in opioid addicted patients undergoing orthopedic surgeries.
Purpose
Treatment
Inclusion/Exclusion criteria
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 .
Age
From 20 years old to 50 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 144
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
Shiraz Medical School Research Ethic Committee
Street address
3rd Floor, 3rd buiding of the Shiraz Medical School, Zand Blvd.
City
Shiraz
Postal code
197871345
Approval date
2016-05-09, 1395/02/20
Ethics committee reference number
IR.sums.med.rec.1395.01

Health conditions studied

1

Description of health condition studied
Acute pain
ICD-10 code
R52.0
ICD-10 code description
Acute Pain

Primary outcomes

1

Description
Postoperative analgesia
Timepoint
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)

Secondary outcomes

1

Description
Sedation
Timepoint
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

2

Description
Patients satisfaction
Timepoint
Every 4 hr during first 24 hr post operation
Method of measurement
Patients satisfaction score : 0 = Completely unsatisfied 1 = Unsatisfied 2 = Neutral 3 = Satisfied 4 = Completely satisfied

3

Description
Postoperative nausea and vomiting
Timepoint
Every 4 hr during first 24 hr post operation.
Method of measurement
By using 3-point scale: 0 = no nausea, vomiting, 1 = nausea only, and 2 = retching or/and vomiting

4

Description
Repiratory depression
Timepoint
Every 4 hr during first 24 hr post operation
Method of measurement
Difined as repiratory rate < 8/min

Intervention groups

1

Description
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 tp the end of the surgery.
Category
Treatment - Drugs

2

Description
In the group B, after induction of anesthesia, 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.
Category
Treatment - Drugs

3

Description
In the control group , after induction of anesthesia, normal saline will be started as a bolus ,followed by an infusion up to end of surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran Training and Medical Center operation room
Full name of responsible person
Mohammad Ali Sahmeddini
Street address
Operating room, Chamran Training and Medical Center, Chamran Blvd.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-Chancellery of Research and Technology
Full name of responsible person
Seyed Basir Hashemi
Street address
Shiraz University Of Medical Sciences building, Zand Blvd.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellery of Research and Technology
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
Shiraz University Of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq.
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
Shiraz Anesthesiology and Critical Care Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3646 7270
Email
sahmeddini@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
MohammadAli Sahmeddini
Position
Associate Professor of Anesthesiology
Other areas of specialty/work
Street address
hiraz Anesthesiology and Critical Care Research Center, Namazi Hospital, Namazi Sq
City
Shiraz
Postal code
7193711351
Phone
+98 71 3647 4270
Fax
+98 71 3647 4270
Email
sahmeddin@sums.ac.ir
Web page address
http://sacrc.sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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