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Completed

NCT Number: NCT03114449

Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty

Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative pain and analgesic requirement in comparison with sham AA in patients after elective knee arthroplasty

Design Prospective randomized controlled blinded clinical trial

Participants:

* Patients < 80 und > 50 years old * scheduled for knee arthroplasty under general anesthesia with < 120 minutes duration * Without previous opioid medication * Able to give informed consent

Outcome measures

* Postoperative analgesic requirement * Incidence of side effects * Physiological parameters

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective knee arthroplasty under general anesthesia
  • Surgery time does not exceed 120 minutes
  • Patients without previous opioid medication
  • Patients ranged 50-80 years old
  • Patients who have given written informed consent

Exclusion criteria

  • Recidivist alcoholics
  • Local auricular skin infection
  • Age < 50 and > 80 years
  • Surgery time more than 120 minutes
  • Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
  • Patients who consumed opioid medication at least 6 months before surgery
  • Patients with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA)
  • Patients who are unable to understand the consent form
  • History of psychiatric disease

Treatment and study plan

Auricular Acupuncture

Device

Auricular acupuncture with indwelling fixed needles at specific AA points

Sham auricular acupuncture

Device

Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points

Primary outcomes

  1. Postoperative requirement of analgesic tilidine (measured in mg)

    Time frame: Six days following surgery

    Requirement of opioid analgesic tilidin

Secondary outcomes

  1. Side effects of analgesics

    Time frame: Six days following surgery

    Incidence of nausea and vomiting

  2. heart rate

    Time frame: 12 hours after surgery

    heart rate

  3. blood pressure

    Time frame: 12 hours following surgery

    blood pressure

  4. Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)

    Time frame: 12 hours following surgery

Sponsors and collaborators

Lead sponsor

University Medicine Greifswald

Other

Collaborators

  • Naemi-Wilke-Stift Guben Hospital - Anesthesia Services

Registry information

Official study title

Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial

Acronym: AA_K-TEP

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 14, 2017
Registry last updated
Apr 14, 2017

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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