The comparison of peri-operative administration of pregabalin and duloxetine effect on post-op pain after Total Knee Arthroplasty (TKA), for studying post-op pain score.
Design
Randomized controlled trial with 3 parallel group include 30 people (overall 90 people) and blinded outcome assessment, included patients choose one card from A-P-D cards and then divided in 3 groups randomly.
Settings and conduct
The people who give drugs to patients and evaluate the effect of drugs, don't know drug's name.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age:40-75, ASA I-II, TKA surgery, Spinal anesthesia
Exclusion criteria:
Lower limbs neuropathy, Therapy with Pregabalin and/or Duloxetine, Drug Abuse, Psychiatric patients that use drugs, Any comorbidity that prevents cooperation * ,Allergy history to drugs which used in research like Pregabalin or Duloxetine, Patient dissatisfaction.
* Pregabalin usage contraindications : 1. Heart conductive Block 2. Heart failure 3. Renal failure
Duloxetine usage contraindication : 1. SIADH 2. Alcohol user 3. Drugs like MAOI that interacts with Duloxetine and causes serotonin syndrome 4. Closed angle glaucoma 5. History of orthostatic hypotension 6. Liver diseases 7. History of seizure 8. Renal failure
Apotel usage contraindications: 1.Liver diseases 2. Alcohol user
Intervention groups
Group (D): Patients who use 30 mg Duloxetine, 1.5 hour before surgery Group(P) : Patients who use 75 mg Pregabalin, 1.5 hour before surgery and Group(A): Patients who use Placebo, 1.5 hour before surgery.
Main outcome variables
Determination of measure of pain with VAS; Determination of consumption of painkiller among patients; Determination of prevalence of post-op complications; Determination of WOMAC questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190719044276N1
Registration date:2020-02-20, 1398/12/01
Registration timing:registered_while_recruiting
Last update:2020-02-20, 1398/12/01
Update count:0
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Niloofar Khosravi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4437 2613
Email address
niloo.kh2000@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-22, 1398/09/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of peri-operative administration of pregabalin and duloxetine on post-op pain after TKA
Public title
The comparison of effect of pregabalin and duloxetine on post-op pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have TKA (total knee arthroplasty) surgery
Patients have spinal anesthesia
Patients are ASA I-II
Exclusion criteria:
Patients don't have consent
Patients with allergy history of pregabalin and duloxetine
Lower limbs neuropathy
Drug abuse
Therapy with pregabalin or deluxetine
Any diseases that hinder patients to cooperate in this research
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
In this research, with convenience method, we collect the numbers of calculated sample of intended patients. Then based on their numbers, we write A, B, C and patients choose from them.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the person who gives medications to patients and evaluates the effects of medications, doesn't know the type of medication.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran university of medical sciences
Street address
Iran university of medical sciences, Shahid Hemat highway,Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-12-03, 1398/09/12
Ethics committee reference number
IR.IUMS.FMD.REC.1398.378
Health conditions studied
1
Description of health condition studied
Post-op pain; Total Knee Arthroplasty surgery
ICD-10 code
G89.1
ICD-10 code description
Acute pain, not elsewhere classified
Primary outcomes
1
Description
The pain score after total knee arthroplasty surgery
Timepoint
1,12,24,48 hours after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: the patients who receive a 75 milligram pregabalin tablet 1.5 hours before surgery and 12 and 24 hours after TKA.
Category
Treatment - Drugs
2
Description
Second intervention group: the patients who receive a 30 milligram duloxetine tablet 1.5 hours before surgery and 12 and 24 hours after TKA.
Category
Treatment - Drugs
3
Description
Control group: the patients who receive a placebo 1.5 hours before surgery and 12 and 24 hours after TKA.