Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty

Knee Replacement Clinical Trial

— TDCSTKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704182
• Other study ID #: tDCS in TKA
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Knee Replacement

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