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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02704182
Other study ID # tDCS in TKA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2015
Est. completion date January 2016

Study information

Verified date September 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 46
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
tDCS
25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
Sham tDCS
25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

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