Protocol summary
-
Study aim
-
Comparison of the prophylactic effect of gabapentin, pregabalin and oral celecoxib on controlling of post oprative pain in orthopeadic surgry of the lower extremities.
-
Design
-
A clinical trial with a community- based and pragmatic control group with parallel-groups double blind randomised
-
Settings and conduct
-
One hundred and twenty patients undergoing lower limb orthopedic surgery in Al-Zahra hospital of Isfahan were selected. To make a double- blinded study the patients were unaware of their groups and the physician who has no role in the process of data collection put every drug in the same capsules with different codes.The physician who prescribed the drugs was unaware of drug content of each capsule as well one hour before the act of spinal anesthesia, the drugs were taken and right after the surgery, pain was measured using the visual analog scale( VAS ).
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria were candidates for elective lower limb orthopedic surgery, absence of uncontrolled systemic diseases.
Exclusion criteria include patient's dissatisfaction, failing of spinal anesthesia (it was tried no more than twice maximum)
-
Intervention groups
-
An hour prior to spinal anesthesia each group was assigned one of the following three medications. 300mg of Gabapentin was given to the first group, 75mg of Pregabalin to the second group and 200mg of Celecoxib to the third group. Placebo was assigned to the 4th group.
-
Main outcome variables
-
Post orthopedic surgical pain of the lower extremities
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20180722040557N1
Registration date:
2018-08-07, 1397/05/16
Registration timing:
prospective
Last update:
2019-01-28, 1397/11/08
Update count:
1
-
Registration date
-
2018-08-07, 1397/05/16
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-08-11, 1397/05/20
-
Expected recruitment end date
-
2018-10-02, 1397/07/10
-
Actual recruitment start date
-
2018-08-15, 1397/05/24
-
Actual recruitment end date
-
2018-10-09, 1397/07/17
-
Trial completion date
-
2018-10-09, 1397/07/17
-
Scientific title
-
Comparison of the prophylactic effects of gabapentin, pregabalin and oral celecoxib and placebo on controlling of postoperative pain in orthopaedic lower extremities surgery with spinal anesthesia
-
Public title
-
Effect of gabapentin, pregabalin and oral celecoxib on controlling of postoprative pain in orthopaedic lower extremities surgrey
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Candidacy of elective lower limb orthopaedic surgery
No contraindication for spinal anesthesia
No restriction for sitting position
Patient's tendency to spinal anesthesia
No risk of increasing intra cranial pressure
No suffering from uncontrolled diseases
No coagulation disorders
Exclusion criteria:
Patient's dissatisfaction to keep on coopration
Failling of spinal anesthesia (it was tried twice maximally)
-
Age
-
From 18 years old to 75 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
120
Actual sample size reached:
120
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The patients were randomly assigned into four groups of 30, the first, second, third and fourth patients were divided into four groups, and the subsequent patients were randomly distributed in groups so that the sample size Enough in all four groups.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
In the current double-blinded study, the patients were unaware of their groups and the physician who did not participate in the process of data collection put all the drugs in the same capsules with different codes.The physician who prescribed the drugs was unaware of drug content of each capsule as well.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-05-31, 1396/03/10
-
Ethics committee reference number
-
396335
Health conditions studied
1
-
Description of health condition studied
-
Postoperative pain of lower limb following orthopaedic lower limb surgery
-
ICD-10 code
-
M79.6
-
ICD-10 code description
-
Pain in limb, hand, foot, fingers and toes
Primary outcomes
1
-
Description
-
Post orthopedic sergical pain of the lower extremities
-
Timepoint
-
Each 60 minutes for 2 times and each 6 hours for the next 4 times
-
Method of measurement
-
Visual analog scale
Intervention groups
1
-
Description
-
Intervention group: One hour prior to spinal anesthesia group 1 received 300 mg gabapentin,
-
Category
-
Treatment - Drugs
2
-
Description
-
Intervention group: One hour prior to spinal anesthesia group 2 received 75 mg pregabalin
-
Category
-
Treatment - Drugs
3
-
Description
-
Intervention group: One hour prior to spinal anesthesia group 3 received 200 mg celecoxib
-
Category
-
Treatment - Drugs
4
-
Description
-
Control group: One hour prior to spinal anesthesia control group recieved placebo
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Esfahan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
No more information
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
publication of the results
-
When the data will become available and for how long
-
Accesibility after data analysis
-
To whom data/document is available
-
all researchers in different fields
-
Under which criteria data/document could be used
-
They should cite to the paper
-
From where data/document is obtainable
-
email to correspond author
-
What processes are involved for a request to access data/document
-
He/She should explain about their research clearly and get the permission of all authors.Then He/She can use the data with citation to our paper
-
Comments
-