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A randomized clinical trial on the effects of oral Pregabalin compared with placebo in acute postoperative pain in patients who undergo Thoracotomy

Protocol summary

Summary
The main objective of this study is evaluating the effect of preoperative administration of pregabalin in relieving postoperative pain after thoracotomy surgery. This study is a randomized, double-blind clinical trial on 60 patients undergoing thoracotomy surgery in Afzalipour hospital of Kerman. Inclusion Criteria: Patients, who are admitted for thoracic surgery, age 20 to 65 year. Exclusion criteria: pregnancy, history of allergy to pregabalin, history of treatment with pregabalin or gabapentin, history of chronic pain syndromes and painkiller consumption, addiction to alcohol or drugs, allergy to pethidine, psychiatric drug consumption, surgery lasting more than 4 hours. The subjects are divided in two groups of intervention and control (receiving pregabalin and placebo respectively) randomly using simple randomization method by random number table. The patients, medicine administrator and the one responsible for recording the score of pain are blind to the used drug. The intervention group will received 300 mg pregabalin orally as a preoperative pain killer two hours prior to surgery. In control group placebo (a capsule similar to original drug without effective substance) is given. The method of anesthesia for both is alike. At the end of operation and transferring to recovery room, the score of pain is measured every 15 minutes for an hour and after transporting to ward, every 4 hours for 24 hours by means of VISUAL ANALOGUE SCALE.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014110210900N4
Registration date: 2016-04-05, 1395/01/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-04-05, 1395/01/17
Registrant information
Name
Hosein Sattari
Name of organization / entity
kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2250
Email address
sattari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman University of Medical Sciences
Expected recruitment start date
2014-01-19, 1392/10/29
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized clinical trial on the effects of oral Pregabalin compared with placebo in acute postoperative pain in patients who undergo Thoracotomy
Public title
analgesic effects of a drug in thoracic surgeries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients, who are admitted for thoracic surgery, age 20 to 65 year. Exclusion criteria: pregnancy, history of allergy to pregabalin, history of treatment with pregabalin or gabapentin, history of chronic pain syndromes and painkiller consumption, addiction to alcohol or drugs, allergy to pethidine, psychiatric drug consumption, surgery lasting more than 4 hours, uncontrolled blood pressure, history of convulsion and the patients who had preoperative pain based on the visual analogue scale (VAS) had preoperative pain.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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
The ethics committee of Kerman University of Medical sciences
Street address
Shafa Square
City
Kerman
Postal code
Approval date
2014-02-19, 1392/11/30
Ethics committee reference number
k/92/489

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
pain
Timepoint
At the end of operation and transferring to recovery room, the score of pain is measured every 15 minutes for an hour and after transporting to ward, every 4 hours for 24 hours
Method of measurement
VISUAL ANALOGUE SCALE

Secondary outcomes

1

Description
the dose of analgesic
Timepoint
during and after surgery
Method of measurement
recording the dose and frequency of administration

Intervention groups

1

Description
In intervention group, 300 mg pregabalin is administered orally as an analgesic, 2 hours before surgery
Category
Treatment - Drugs

2

Description
In control group placebo (a capsule similar to the drug without any effective substance) is administered.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Hosseyn Sattari
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
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, Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Hosein Sattari
Position
assistant professor of anesthesiology
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
hosattari@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Jalalifard
Position
medical student
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
00
Fax
Email
javakrd34@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hosein Sattari
Position
Assistant professor of ANESTHESIOLOGY
Other areas of specialty/work
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Postal code
Phone
+98 34 3223 5011
Fax
Email
sattari@kmu.ac.ir
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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