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Completed

NCT Number: NCT02704182

Transcranial Direct Current Stimulation for Postoperative Pain in Knee Arthroplasty

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.

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Key information

Conditions

Knee Replacement

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Providing informed consent to participate in the study.
  • age >30 years and <60 years both genders.
  • ASA I to II patients.
  • postoperative unilateral total knee arthroplasty.

Exclusion criteria

  • Contraindications to transcranial brain stimulation: presence of a history of epilepsy, implantable devices (ventriculo-peritoneal shunts, pacemakers, intracranial metal implants).
  • Neurological or psychiatric pathology.
  • Patients taking major centrally acting drugs (anti-epileptics or antidepressants) or high-dose opioid.
  • History of substance abuse.
  • Severe cardio-pulmonary, renal, hepatic diseases.
  • Pregnancy and lactation.

Treatment and study plan

tDCS

Device

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

Sham tDCS

Device

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

Primary outcomes

  1. Opioids consumption per 24 hours at the 4th day postoperative

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 1st day postoperative

    Measuring the consumption dose of opioids per 24 hours at the 1st day postoperative

Secondary outcomes

  1. Opioid side effects

    Time frame: 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

    Time frame: 3rd postoperative day

    Pain Assessment using Visual Analogue Scale

  3. Pain assessment by VAS

    Time frame: 2nd postoperative day

    Pain Assessment using Visual Analogue Scale

  4. Pain assessment by VAS

    Time frame: 1st postoperative days

    Pain Assessment using Visual Analogue Scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: TDCSTKA

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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