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Effect of preoperative oral gabapentin on post operative pain in opioid addicted patients

Protocol summary

Summary
Objectives: To investigate the effects of gabapentin in postoperative pain after orthopedic surgery in patients addicted to opioids. Research Design: A randomized, double-blind, clinical trial. Inclusion criteria: age 70-20 years, ASA class I- II, patients undergoing surgery for hip fracture and lower extremity. Exclusion criteria: hypersensitivity to the Gabapentin, a seizure history, a history of taking gabapentin, mental illness, liver or kidney disease, pregnancy, multiple simultaneous fractures64 Patients are randomly divided into two groups P and G. Patients in recovery room were treated according to the severity of pain as follows: morphine 2 mg every 5 minutes with pain score more than 7 until the pain score reaches to the 4, and 1 mg morphine every 5 minutes with pain score of 4 -6 until the pain intensity reaches to 4. In the surgery ward morphine pump was used for patients in the both groups, as follows, a solution of 0.5 mg per/cc with 2 mg and interval locked out 6 minutes and the maximum dose of 50 mg every 4 hours .At2, 4, 6, 12, 18 and 24 hours after surgery parameters (in the time of the rest), insomnia, shivering, nausea, urinary retention, sedation and degree of patient satisfaction measured and data were recorded in a special form.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014122019470N4
Registration date: 2015-04-01, 1394/01/12
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-01, 1394/01/12
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Science
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preoperative oral gabapentin on post operative pain in opioid addicted patients
Public title
Effect of preoperative oral gabapentin on post operative pain in opioid addicted patients with lower extrimity orthopedic surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age 70-20 years, ASA class I- II, patients undergoing surgery for hip fracture and lower extremity. Exclusion criteria: hypersensitivity to the Gabapentin, a seizure history, a history of taking gabapentin, mental illness, liver or kidney disease, pregnancy, multiple simultaneous fractures
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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 Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
CP-P-9356-5676

Health conditions studied

1

Description of health condition studied
Major Orthopedic Surgery
ICD-10 code
M96.6
ICD-10 code description
Fracture of Bone following Insertion of Orthopedic Inplant, joint,...

Primary outcomes

1

Description
the effect of oral gabapentin on post operative pain in opioid addicted patients with orthopedic surgeris
Timepoint
pain score were recorded at 0,1,3,6 and 24 hours in the post-operative period.
Method of measurement
NRS

Secondary outcomes

1

Description
Patient's satisfaction
Timepoint
at 0,1,3,6 and 24 hours in the post-operative period.
Method of measurement
Four Point Categorical Scale

Intervention groups

1

Description
Intervention group: patients received 300 mg gabapentin one hour before the surgery.
Category
Treatment - Drugs

2

Description
control group: patients received same capsule as placebo one hour before the surgery.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Street address
Chamran Hospital, Chamran Boulevard
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice Chancellor for Research, Shiraz University of Medical Sciences, 7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Shiraz 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
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Elham Sabokseir
Position
Physician, Anesthesiology Resident
Other areas of specialty/work
Street address
Anesthesiology Department, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
sabokseir@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University Of Medical Sciences
Full name of responsible person
Saeid Khademi
Position
Anesthesilogist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3235 7282
Fax
Email
khademisaeid@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
English Consultant,Anesthesiology Research Center Staff
Other areas of specialty/work
Street address
Anesthesiology Office, Namazi Hospital
City
Shiraz
Postal code
Phone
+98 71364774270
Fax
Email
masihif@sums.ac.com; masihifarzaneh@yahoo.com
Web page address

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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