Protocol summary

Summary
Objectives: This study aimed to investigate the effect of preoperative prescription of two drugs Celexib and Peregabalin on postoperative pain after Orthopedic surgery is performed on volunteer patients. Study design: Randomized, double-blind, placebo-controlled, single-center, two trials study. Study setting and conduct: Before entering the operating room, patients are randomly with table of random numbers divided into three groups Celexib, peregabalin and placebo, as we do without any premedication to patients such as: Morphine, fentanyl, benzodiazepine, and so on. After referring to the ward, three hours before surgery, one patient is placed randomly in Celexib group with dose of 200 mg, one patient is placed randomly in Peregabalin group with dose of 150 mg and one patient is placed randomly in the placebo group with dose of 10 ml of normal saline 0.9%intravenously through an Angiocatheter. The method of injection and maintenance of anesthesia for all patients is the same. Presence or absence of pain in all three groups is investigated by an experienced person who is not aware of the type of drug by filling out the questionnaire, according to the pain score that stated in the questionnaire, at the end of specific time in recovery room, i.e. 45 minutes after regaining consciousness as well as, three hours after entering the ward. Participants including major eligibility criteria: Volunteer Orthopedic surgery patients between 18 and 65 years. Major exclusive criteria: People under 18 and over 65 years; Drug addicts; Diabetics; Patients with Cardiovascular Disorders; Patients who are taking Steroids for any reason; Patients who are taking Nonsteroidal anti-inflammatory drugs ongoing; Pregnant women; Patients who are taking Antidepressant and Antipsychotic drugs; Patients with fractures of the femor and pelvis.Sample: Three groups of 40 patients each. Interventions: Prescription of Celexib in one group, Peregabalin in another group and 0.9% Normal saline in the third group before surgery in order to evaluate postoperative pain in each group. The intervening time: Three hours before entering to Operation room. Variables of main outcome: Pain is as the independent continual variable and drug is as the independent nominal variable.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016012715281N5
Registration date: 2016-08-06, 1395/05/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-08-06, 1395/05/16
Registrant information
Name
Seyedebrahim Sadeghi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 4333 3278
Email address
esadeghi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chanecellor of research, Shiraz University of Medical Sciences (International Branch)
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial comparing preoperative prescription of two drugs Celexib and Peregabalin on postoperative pain in patients volunteer Orthopedic surgery.
Public title
Celexib and Peregabalin effect on pain after Orthopedic surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Volunteer Orthopedic surgery patients between 18 and 65 years. Exclusion criteria: People under 18 and over 65 years; Drug addicts; Diabetics; Patients with Cardiovascular Disorders; Patients who are taking Steroids for any reason; Patients who are taking Nonsteroidal anti-inflammatory drugs ongoing; Pregnant women; Patients who are taking Antidepressant and Antipsychotic drugs; Patients with fractures of the femor and pelvis.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
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 (International Branch)
Street address
Shiraz University of Medical Sciences( International Branch), Injuries and Burn Hospital entrance, 3rd km of Sadra road.
City
Shiraz
Postal code
7144716699
Approval date
2016-06-07, 1395/03/18
Ethics committee reference number
IR.SUMS.REC.1395.36

Health conditions studied

1

Description of health condition studied
The pain after Orthopedic surgeries.
ICD-10 code
T84.9
ICD-10 code description
Other Complication of Orthopedic surgeries.

Primary outcomes

1

Description
Pain level after Orthopedic surgery.
Timepoint
The pain is investigated 45 minutes after the end of anesthesia in the recovery room and three hours after entering the ward.
Method of measurement
Visual and intrrogative measure of pain from the patient and complete the questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
The control group: The first group; 10 mL of 0.9% Normal Saline IV through Angiocatheter; Three hours before entering the Operation room.
Category
Placebo

2

Description
The intervention group: The second group; Celexib of abooreihan factory with the dose of 200 mg orally; Three hours before entering the Operation room.
Category
Treatment - Drugs

3

Description
The intervention group: The group third; Peregabalin of abooreihan factory with the dose of 150 mg orally; Three hours before entering the Operation room.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Marvdasht Martyr Motahari Hospital
Full name of responsible person
Dr. Seyed Ebrahim Sadeghi
Street address
Marvdasht Martyr Motahari Hospital, After Teacher underpass, Marvdasht.
City
Marvdasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences (International Branch)
Full name of responsible person
Dr. Ali Akbari
Street address
Shiraz University of Medical Sciences( International Branch), Injuries and Burn Hospital entrance, 3rd km of Sadra road.
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 (International Branch)
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 Sciences
Full name of responsible person
Dr. Seyed Ebrahim Sadeghi
Position
Anesthesiologist with Anesthesia Fellowship of Cardiovascular surgery, Assistant professor of Anesth
Other areas of specialty/work
Street address
Marvdasht Martyr Motahari Hospital, After Teacher underpass, Marvdasht.
City
Marvdasht
Postal code
Phone
+98 71 4334 5705
Fax
Email
seyedebrahims@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Seyed Ebrahim Sadeghi
Position
Anesthesiologist with Anesthesia Fellowship of Cardiovascular surgery.
Other areas of specialty/work
Street address
Marvdasht Martyr Motahari Hospital, After Teacher underpass, Marvdasht.
City
Marvdasht
Postal code
Phone
+98 71 4334 5705
Fax
Email
seyedebrahims@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
Dr. Seyed Ebrahim Sadeghi
Position
Anesthesiologist with Anesthesia Fellowship of Cardiovascular surgery, Assistant professor of Anesth
Other areas of specialty/work
Street address
Marvdasht Martyr Motahari Hospital, After Teacher underpass, Marvdasht.
City
Marvdasht
Postal code
Phone
+98 71 4334 5705
Fax
Email
seyedebrahims@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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