TDCSTKA: Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02704182
• Collaborator: (none)
• Enrollment: 46
• Arms: 2
• Duration (Months): 7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Replacement	Device: tDCS; Device: Sham tDCS	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Role of Transcranial Direct Current Stimulation (tDCS) in Reduction of Pain and Postsurgical Opioid Consumption in Total Knee Arthroplasty (TKA)
• Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Real 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.	Device: tDCS; 25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
Sham Comparator: 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.	Device: Sham tDCS; 25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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 Outcome Measures

1. Opioid side effects [4th post operative day]

   Record Opioid-related adverse effects (nausea and/or vomiting and the need for alizapride 50mg IV).

2. Pain assessment by VAS [3rd postoperative day]

   Pain Assessment using Visual Analogue Scale

3. Pain assessment by VAS [2nd postoperative day]

   Pain Assessment using Visual Analogue Scale

4. Pain assessment by VAS [1st postoperative days]

   Pain Assessment using Visual Analogue Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eman M. Khedr, Clinical Professor, Assiut University
• ClinicalTrials.gov Identifier: NCT02704182
• Other Study ID Numbers: tDCS in TKA
• First Posted: Mar 9, 2016
• Last Update Posted: Sep 16, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Eman M. Khedr, Clinical Professor, Assiut University: Arthroplasties, Knee Replacement

Study Results

No Results Posted as of Sep 16, 2020