Clinical trial NCT02704182: Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty
Official title: Role of Transcranial Direct Current Stimulation (tDCS) in Reduction of Pain and Postsurgical Opioid Consumption in Total Knee Arthroplasty (TKA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Replacement
Keywords: Arthroplasties, Knee Replacement
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 46
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Opioids consumption per 24 hours at the 4th day postoperative
timeFrame: day 4 postoperative
measure: Opioids consumption / 24 hours at the third day postoperative
timeFrame: day 3 postoperative
measure: Opioids Consumption / 24 hours at the second day postoperative
timeFrame: day 2 postoperative
measure: Opioids consumption / 24 hours at the 1st day postoperative
timeFrame: 1st day postoperative
Secondary outcomes:
measure: Opioid side effects
timeFrame: 4th post operative day
measure: Pain assessment by VAS
timeFrame: 3rd postoperative day
measure: Pain assessment by VAS
timeFrame: 2nd postoperative day
measure: Pain assessment by VAS
timeFrame: 1st postoperative days
Other outcomes:
Locations:
Study officials:
References:
citation: Khedr EM, Sharkawy ESA, Attia AMA, Ibrahim Osman NM, Sayed ZM. Role of transcranial direct current stimulation on reduction of postsurgical opioid consumption and pain in total knee arthroplasty: Double randomized clinical trial. Eur J Pain. 2017 Sep;21(8):1355-1365. doi: 10.1002/ejp.1034. Epub 2017 Apr 25.