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Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty (AA_K-TEP)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Auricular acupuncture
Sham auricular acupuncture
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Recidivist alcoholics
  2. Local auricular skin infection
  3. Age < 50 and > 80 years
  4. Surgery time more than 120 minutes
  5. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
  6. Patients who consumed opioid medication at least 6 months before surgery
  7. 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)
  8. Patients who are unable to understand the consent form
  9. History of psychiatric disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Auricular acupuncture

    Sham auricular acupuncture

    Arm Description

    Auricular acupuncture (AA) with indwelling fixed needles at specific AA points

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

    Outcomes

    Primary Outcome Measures

    Postoperative requirement of analgesic tilidine (measured in mg)
    Requirement of opioid analgesic tilidin

    Secondary Outcome Measures

    Side effects of analgesics
    Incidence of nausea and vomiting
    heart rate
    heart rate
    blood pressure
    blood pressure
    Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)

    Full Information

    First Posted
    April 3, 2017
    Last Updated
    April 10, 2017
    Sponsor
    University Medicine Greifswald
    Collaborators
    Naemi-Wilke-Stift Guben Hospital - Anesthesia Services
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03114449
    Brief Title
    Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty
    Acronym
    AA_K-TEP
    Official Title
    Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (Actual)
    Primary Completion Date
    December 2013 (Actual)
    Study Completion Date
    December 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Medicine Greifswald
    Collaborators
    Naemi-Wilke-Stift Guben Hospital - Anesthesia Services

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    150 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Auricular acupuncture
    Arm Type
    Experimental
    Arm Description
    Auricular acupuncture (AA) with indwelling fixed needles at specific AA points
    Arm Title
    Sham auricular acupuncture
    Arm Type
    Sham Comparator
    Arm Description
    Sham auricular acupuncture with indwelling fixed needles at non- AA points
    Intervention Type
    Device
    Intervention Name(s)
    Auricular acupuncture
    Intervention Description
    Auricular acupuncture with indwelling fixed needles at specific AA points
    Intervention Type
    Device
    Intervention Name(s)
    Sham auricular acupuncture
    Intervention Description
    Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points
    Primary Outcome Measure Information:
    Title
    Postoperative requirement of analgesic tilidine (measured in mg)
    Description
    Requirement of opioid analgesic tilidin
    Time Frame
    Six days following surgery
    Secondary Outcome Measure Information:
    Title
    Side effects of analgesics
    Description
    Incidence of nausea and vomiting
    Time Frame
    Six days following surgery
    Title
    heart rate
    Description
    heart rate
    Time Frame
    12 hours after surgery
    Title
    blood pressure
    Description
    blood pressure
    Time Frame
    12 hours following surgery
    Title
    Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)
    Time Frame
    12 hours following surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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