Comparison effect of Apotel and Pergabalin in reduce pain after in orthopedic surgery
Design
This study is clinical trials and double blind.75 patients candidate orthopedic surgery in lower limb will enter in Valiasr hospital.patients will divide in three groups.We treat patients 150 miligeram pregabalin 2 hours before surgery in intervention group.We treat patients 1 gram Apotel 20 minute before surgery in intervention group.We treat patients one capsule placebo before surgery in intervention group.We record pain in recovery, 2 and 12 and 24 hours after surgery. We record consumption of opioids in 24 hours in milligram.We record ramsy sedation score in 24 hours after surgery.
Settings and conduct
This study is clinical trials and double blind.75 patients candidate orthopedic surgery in lower limb will enter in Valiasr hospital in Arak city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidate orthopedic surgery lower limb; 17 to 65 years; both of two gender
Negative entry conditions: Coagulation disorders; Unwillingness to participate in the study; Severe hemodynamic instability; Hepatic, renal and cardiac disease; sensitivity to Pregabalin and Apotel
Intervention groups
We treat patients 150 miligeram pregabalin 2 hours before surgery in intervention group.We treat patients 1 gram Apotel 20 minute before surgery in intervention group.We treat patients one capsule placebo before surgery in intervention group.
Main outcome variables
We record pain in recovery, 2 and 12 and 24 hours after surgery. We record consumption of opioids in 24 hours in milligram.We record ramsy sedation score in 24 hours after surgery.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N61
Registration date:2018-01-09, 1396/10/19
Registration timing:registered_while_recruiting
Last update:2018-01-09, 1396/10/19
Update count:0
Registration date
2018-01-09, 1396/10/19
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Apotel and Pergabalin in reduce pain after in orthopedic surgery
Public title
Comparison effect of Apotel and Pergabalin in reduce pain after in orthopedic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
candidate orthopedic surgery lower limb
17 to 65 years
both of two gender
Exclusion criteria:
Coagulation disorders
Unwillingness to participate in the study
Severe hemodynamic instability
Hepatic, renal and cardiac disease
Sensitivity to Pregabalin and Apotel
Age
From 17 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blind. The participant and the outcome evaluator are unaware.
blindness in control group,we give normal saline in serum and capsule of placebo.blindness in intervention group, we give apotel in serum and capsule of placebo.blindness in another intervention group normal saline in serum and tab of Pregabalin. In this way, patients are not informed of the group they are in
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences