Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty

Study Overview
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Brief Summary
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The objective of this study is to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (base line) after 1st, 2nd, 3rd and 4th sessions.

Detailed Description
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The study aims to to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients. Fifty patients undergoing unilateral TKA will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tDCS (n=25). Stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive Sham tDCS. Pain level will be evaluated according to visual analogue scale (VAS) and LANSS pain scale before (baseline) after 1st, 2nd, 3rd and 4th sessions.

Official Title
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Role of Transcranial Direct Current Stimulation (tDCS) in Reduction of Pain and Postsurgical Opioid Consumption in Total Knee Arthroplasty (TKA)

Conditions
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Knee Replacement

Intervention / Treatment
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* Device: tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Providing informed consent to participate in the study. age >30 years and <60 years both genders. ASA I to II patients. postoperative unilateral total knee arthroplasty. Exclusion Criteria: Contraindications to transcranial brain stimulation: presence of a history of epilepsy, implantable devices (ventriculo-peritoneal shunts, pacemakers, intracranial metal implants). Neurological or psychiatric pathology. Patients taking major centrally acting drugs (anti-epileptics or antidepressants) or high-dose opioid. History of substance abuse. Severe cardio-pulmonary, renal, hepatic diseases. Pregnancy and lactation.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real tDCS<br>Direct current stimulation using anodal electrode, 25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days. | Device: tDCS<br>* 25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.<br>|
| Sham Comparator: Sham tDCS<br>Sham direct current stimulation, 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days. | Device: Sham tDCS<br>* 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioids consumption per 24 hours at the 4th day postoperative | Measuring the consumption dose of opioids per 24 hours at the fourth day | day 4 postoperative | 
| Opioids consumption / 24 hours at the third day postoperative | Measuring the consumption dose of opioids per 24 hours at the third day postoperative | day 3 postoperative | 
| Opioids Consumption / 24 hours at the second day postoperative | Measuring the consumption dose of opioids per 24 hours at the second day post-operative | day 2 postoperative | 
| Opioids consumption / 24 hours at the 1st day postoperative | Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative | 1st day postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid side effects | Record Opioid-related adverse effects (nausea and/or vomiting and the need for alizapride 50mg IV). | 4th post operative day | 
| Pain assessment by VAS | Pain Assessment using Visual Analogue Scale | 3rd postoperative day | 
| Pain assessment by VAS | Pain Assessment using Visual Analogue Scale | 2nd postoperative day | 
| Pain assessment by VAS | Pain Assessment using Visual Analogue Scale | 1st postoperative days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasties, Knee Replacement