In this study, after obtaining the approval of the institutional board committee (Iran University of Medical Sciences, IUMS) and written consent of the patients, 76 patients aged 20-70 years old, classified ASA physical status I–II who were candidate for orthopedic surgery on lower extremity fractures under similar general anesthesia were studied. Patients were randomly divided in two groups (control and case). For postoperative analgesia in both groups patient controlled intravenous analgesia (PCIA) with morphine (0.2mg/ml) was given on a continuous flow rate (5ml/h). In the case of breakthrough pain (VAS>3), 2mg iv morphine was administered. In the case group, loading dose of 600mg oral gabapentin within 6 hours after surgery and 300mg every 12 hours was administered until 72 hours after surgery. In the control group placebo was given instead of gabapentin. Pain score were evaluated by a visual analog scale (VAS). In cases of the VAS<2, the continuous infusion of morphine were decreased to %50. Pain score, analgesic consumption and side effects were assessed every 12 hours for three days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201010072366N3
Registration date:2010-10-23, 1389/08/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-23, 1389/08/01
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences (IUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
imani.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences (IUMS)
Expected recruitment start date
2009-01-19, 1387/10/30
Expected recruitment end date
2010-01-20, 1388/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding oral gabapentin to morphine patient-controlled iv analgesia (PCIA) on pain after orthopedic surgery
Public title
The effect of adding oral gabapentin to morphine patient-controlled iv analgesia (PCIA) on pain after orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients aged 20-70 years old, classified ASA physical status I–II who were candidate for orthopedic surgery on lower extremity fractures under general anesthesia.
Exclusion criteria: severe uncontrolled co-existing diseases (CNS, convulsive, cardiovascular, ...), renal failure, concurrent use of anticonvulsant drug and /or other analgesic drugs, alcohol, addiction, known allergy to gabapentin or morphine, and patient refusal.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
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
Iran University of Medical Sciences
Street address
Crossroads of Hemmat & Chamran Expressways
City
Tehran
Postal code
14496
Approval date
2009-03-06, 1387/12/16
Ethics committee reference number
1177710
Health conditions studied
1
Description of health condition studied
Analgesia after orthopedic surgery for lower extremity fractures
ICD-10 code
S72
ICD-10 code description
Fracture of femur
Primary outcomes
1
Description
postoperative analgesia
Timepoint
every 12 hrs
Method of measurement
Visual analoque scale, and analgesic consumption
Secondary outcomes
1
Description
Side effects
Timepoint
every 12 hours
Method of measurement
Observation and evaluation of patients
Intervention groups
1
Description
Control group: administration of placebo every 12 hours in patient under iv morphine pump for three days.
Category
Placebo
2
Description
Case group: administration of gabapentin 300 mg every 12 hours in patient under iv morphine pump for three days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool-Akram Hospital
Full name of responsible person
Farnad Imani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences (IUMS)
Full name of responsible person
Dr Maziar Moradi-lakeh, Director of Research and Technology
Street address
Crossroads of Hemmat & Chamran Expressways
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences (IUMS)
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
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Chairman, Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology & Pain Medicine, Rasool-Akram Hospital
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Rasool-Akram Hospital
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farnad Imani
Position
Chairman/ Department of Anesthesiology
Other areas of specialty/work
Street address
Department of Anesthesiology & Pain Medicine, Rasool-Akram Hospital, Niayesh St, Sattar-khan Av
City
Tehran
Postal code
1445613131
Phone
+98 21 6651 5758
Fax
+98 21 6651 5758
Email
farimani@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)