Objective: clinical trial of comparing the efficacy of different doses of pregabalin on postoperative pain in patients undergoing lumbar disc herniation surgery. Study design: randomization using random permuted blocks, convenience sampling, double-blind, single-center, phase II trial. Study population: all patients of lumbar disc herniation surgery with ASA PS I and II. Main inclusion criteria: age limitation 20-60 years; candidates of lumbar disc herniation surgery with ASA PS I and II. Main exclusion criteria: renal and liver dysfunction; usage of alcohol or any other drug; internal disease such as uncontrolled diabetes or hypertension; NSAID usage 24 hours prior to surgery; emergent surgery for any reason. Sample size: 90. Interventions: First group: administration of placebo as oral capsules containing starch an hour before surgery; second group: administration of pregabalin (Lyrica) orally 75 mg one hour prior to surgery; third group: administration of pregabalin (Lyrica) orally 150 mg one hour prior to surgery. Intervention time: before the operation. Outcomes: postoperative pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017030132832N1
Registration date:2017-05-24, 1396/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-24, 1396/03/03
Registrant information
Name
Fatemeh Dalaki
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 8498
Email address
dalakidr@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-06-04, 1395/03/15
Expected recruitment end date
2017-06-05, 1396/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of different doses of pregabalin on postoperative pain in patients undergoing lumbar disc herniation surgery
Public title
Evaluation the effect of two different doses of pregabalin before surgery on postoperative pain after lumbar disc surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: age between 20-60 years old; candidates of lumbar disc herniation surgery with ASA PS I and II. Main exclusion criteria: renal and liver dysfunction; usage of alcohol or any other drug; internal disease such as uncontrolled diabetes or hypertension; NSAID usage 24 hours prior to surgery; emergent surgery for any reason.
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Zahedan University of Medical Sciences
Street address
Ethics Committee of Zahedan University of Medical Sciences, Zahedan University of Medical Sciences, Dr.Hesabi Square, Zahedan
City
Zahedan
Postal code
Approval date
2016-04-20, 1395/02/01
Ethics committee reference number
IR.ZAUMS.REC.1395.16
Health conditions studied
1
Description of health condition studied
Lumbar disc herniation surgery
ICD-10 code
M51.9
ICD-10 code description
Other intervertebral disc disorders
Primary outcomes
1
Description
Postoperation pain
Timepoint
Two houres, four houres, eight houres, 12 houres and 24 houres after surgery
Method of measurement
VAS Criteria
Secondary outcomes
empty
Intervention groups
1
Description
First group(control): administration of placebo as oral capsules containing starch an hour before surgery
Category
Placebo
2
Description
Intervention group I: administration of pregabalin (Lyrica) orally 75 mg one hour prior to surgery
Category
Treatment - Drugs
3
Description
Intervention group II: administration of pregabalin (Lyrica) orally 150 mg one hour prior to surgery.