Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty
- Conditions
- Knee Replacement
- Interventions
- Device: tDCSDevice: Sham tDCS
- Registration Number
- NCT02704182
- Lead Sponsor
- Assiut University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Real tDCS tDCS 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. Sham tDCS Sham tDCS Sham direct current stimulation, 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
- Primary Outcome Measures
Name Time Method Opioids consumption / 24 hours at the 1st day postoperative 1st day postoperative Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative
Opioids Consumption / 24 hours at the second day postoperative day 2 postoperative Measuring the consumption dose of opioids per 24 hours at the second day post-operative
Opioids consumption per 24 hours at the 4th day postoperative day 4 postoperative Measuring the consumption dose of opioids per 24 hours at the fourth day
Opioids consumption / 24 hours at the third day postoperative day 3 postoperative Measuring the consumption dose of opioids per 24 hours at the third day postoperative
- Secondary Outcome Measures
Name Time Method Pain assessment by VAS 1st postoperative days Pain Assessment using Visual Analogue Scale
Opioid side effects 4th post operative day Record Opioid-related adverse effects (nausea and/or vomiting and the need for alizapride 50mg IV).