Knee Replacement
Conditions
Keywords
Arthroplasties, Knee Replacement
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.
Interventions
DEVICEtDCS
25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
DEVICESham tDCS
25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Providing informed consent to participate in the study. 2. age \>30 years and \<60 years both genders. 3. ASA I to II patients. 4. postoperative unilateral total knee arthroplasty.
Exclusion criteria
1. Contraindications to transcranial brain stimulation: presence of a history of epilepsy, implantable devices (ventriculo-peritoneal shunts, pacemakers, intracranial metal implants). 2. Neurological or psychiatric pathology. 3. Patients taking major centrally acting drugs (anti-epileptics or antidepressants) or high-dose opioid. 4. History of substance abuse. 5. Severe cardio-pulmonary, renal, hepatic diseases. 6. Pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 / 24 hours at the 1st day postoperative | 1st day postoperative | Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid side effects | 4th post operative day | Record Opioid-related adverse effects (nausea and/or vomiting and the need for alizapride 50mg IV). |
| Pain assessment by VAS | 3rd postoperative day | Pain Assessment using Visual Analogue Scale |
Outcome results
None listed