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The effects of preoperative administration of oral pregabalin on postoperative pain after abdominal surgeries

Protocol summary

Summary
The purpose of this study was to evaluate the effects of preoperative administration of oral pregabalin on postoperative pain after surgery in thepatients undergoing general anesthesia for abdominal surgeries in Shahid Sadoughi hospital in Yazd, Iran. In this randomized double blind trial, 60 patients, aged 40-60 years old, and ASA physical status I and II, were assigned into one of the following two groups to receive pregabalin,300 miligramgram 2 hours before surgery, orally in the intervention group or placebo in the control group Intravenous pump with 20 mg morphin in 100 ml normal saline was used as the analgesic method postoperatively and the patients received morphine as bolus doses according to their requests. Pain was assessed through visual analog scale (VAS) at 2, 6, 12, and 24 hours after the surgery. In addition, the first request of the patient for analgesia, the amount of morphine consumed, and side effects of gabapentin (dizziness, blurred vision, ataxia, nausea, vomiting) were evaluated during 24 hours and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201408272963N19
Registration date: 2014-12-26, 1393/10/05
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-26, 1393/10/05
Registrant information
Name
Shekoufeh Behdad
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 1386
Email address
drbehdad@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of preoperative administration of oral pregabalin on postoperative pain after abdominal surgeries
Public title
Evaluation of the effects of preoperative administration of oral pregabalin on postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women with American Society of Anesthesia (ASA) physical status I or II who are candidate for elective abdominal surgery, age 40-60 years old, BMI<35. Exclusion criteria: Anaphylaxis reaction to the anesthetic drugs, duration of the operation longer than 2 hours
Age
From 40 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
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
دانشگاه شهید صدوقی
Street address
میدان باهنر
City
یزد
Postal code
Approval date
2014-09-10, 1393/06/19
Ethics committee reference number
9630

Health conditions studied

1

Description of health condition studied
pregabalin
ICD-10 code
Y46.6
ICD-10 code description
Other and unspecified antiepileptics

Primary outcomes

1

Description
postoperative pain
Timepoint
2,6,12,24 hours postoperatively
Method of measurement
visual analog pain score

Secondary outcomes

1

Description
side effects of pregabalin (dizziness, blured vision, ataxia, nausea, vomitting)
Timepoint
2, 6, 12 and 24 hours after operation
Method of measurement
asking the patient, physical examination

Intervention groups

1

Description
pregabalin 300 mg orally 2 hours before surgery
Category
Treatment - Drugs

2

Description
placebo at the same time
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Dr. Shekoufeh Behdad
Street address
Shahid Sadoughi Hospital,Ebnesina Blv,Yazd, Iran
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Hasan Mozaffari
Street address
Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi 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
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Shekoufeh Behdad
Position
Associate Professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 3822 4104
Fax
Email
behdad90@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Shekoufeh Behdad
Position
associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 3822 4101
Fax
Email
behdad90@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Shekoufeh Behdad
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Sadoughi Hospital
City
Yazd
Postal code
Phone
+98 35 3822 4105
Fax
Email
behdad90@gmail.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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