The aim of this randomized double-blind trial is to evaluate effect of ultra low dose Naloxan on pain intensity after lumbar disc surjury.A total of 70 patients meeting eligibility criteria were randomly allocated into two equal groups.After establishment of monitoring the operating room , all patients with an identical anesthetic technique including midazolam 0.1mg/kg and Fentanyl 2mcg/kg for Pre-medication and Thiopental 5mg/kg and atracurium 0.5mg/kg for induction of anesthesia and during anesthesia N2O 50% and Isofluran 1MAC and morphine 0.1mg/kg and 0.1mg/kg atracurium based on the patient's needs will be put under general anesthesia .After emergence from anesthesia and log in recovery room for all patients for pain control PCA Pump will be used that contents 40mgr Morphine in 80cc Normal Saline with background infusion rate 2cc/hr and bolus dose 0.5cc and lockout 15min .For intervention group Naloxone 025mcg/kg/hr in 500cc normal saline will be infused Intravenously in 24 hours.For control group 500cc normal saline as a Placebo will be infused in 24 hours. severity of pain and nausea / vomiting and pruritus in both groups 1, 6, 12 and 24 hours after surgery will be recorded
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312126803N5
Registration date:2014-03-03, 1392/12/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-03, 1392/12/12
Registrant information
Name
Abolfazl Firouzian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1222 6655
Email address
a.firouzian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Council of Mazandaran University of Medical Sciences
Sari
Mazandaran
Iran
866-48175
00981513261245
00981513262679
medjournal@mazums.ac.ir
www.mazums.ac.ir
Expected recruitment start date
2013-09-11, 1392/06/20
Expected recruitment end date
2014-05-10, 1393/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of ultra low-dose naloxone on pain after lumbar disc surgery.
Public title
The effect of naloxone on pain after surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) confirm the diagnosis with a physical examination and MRI 2) the willingness of patients to participate in the study and informed consent 3) non-emergency elective surgery discectomy 4) Age between 35-55 years Exclusion criteria: 1) patient reluctance every time that continued in the study, 2) a history of psychological illness, 3) a history of seizures, 4) abuse of alcohol or drugs 5) any unusual complications during surgery, 6) lack of neurologic injury
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Moallem Square. Sari Mazandaran Iran, Islamic Republic Of 4817844718
City
Sari
Postal code
4814839953
Approval date
2013-09-11, 1392/06/20
Ethics committee reference number
92-92
Health conditions studied
1
Description of health condition studied
Pain after lumbar disc surgery
ICD-10 code
Y45.0
ICD-10 code description
Complications of medical and surgical care,Opioids and related analgesics
Primary outcomes
1
Description
Pain intensity after surgery
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale and Record in Questionnaire
Secondary outcomes
1
Description
Amount of opioid consumption after surgery
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale and Record in Questionnaire
2
Description
Pruritis after surgery
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale and Record in Questionnaire
3
Description
Vomiting and nausea after surgery
Timepoint
1, 6, 12 and 24 hours after surgery
Method of measurement
Visual Analog Scale and Record in Questionnaire
Intervention groups
1
Description
Infusion of Naloxone 0.25mcg/kg/hr/IV in 500cc normal saline in 24 hours
Category
Treatment - Drugs
2
Description
Infusion of Normal saline 500cc/IV in 24 hours
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital
Full name of responsible person
Abolfazl Firouzian MD, Assistant Professor
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square.
City
Sari
Grant name
10506
Grant code / Reference number
92-92
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mazandaran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Abolfazl Firouzian MD
Position
Anesthesiologist, Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4814839953
Phone
+98 15 1227 5038
Fax
+98 15 1227 5038
Email
A.firouzian@mazums.ac.ir; Ab.firouzian@gmail.com
Web page address
www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Behrouz Kheradmand MD
Position
Resident of anesthesiology
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Amir mazandarani Ave.
City
Sari
Postal code
4818845361
Phone
+98 15 1310 6533
Fax
+98 15 1227 5038
Email
BKH1358@yahoo.com
Web page address
www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)