NCT03114449

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable postoperative-pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
Last Updated

April 14, 2017

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

April 3, 2017

Last Update Submit

April 10, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative requirement of analgesic tilidine (measured in mg)

    Requirement of opioid analgesic tilidin

    Six days following surgery

Secondary Outcomes (4)

  • Side effects of analgesics

    Six days following surgery

  • heart rate

    12 hours after surgery

  • blood pressure

    12 hours following surgery

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

    12 hours following surgery

Study Arms (2)

Auricular acupuncture

EXPERIMENTAL

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

Device: Auricular acupuncture

Sham auricular acupuncture

SHAM COMPARATOR

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

Device: Sham auricular acupuncture

Interventions

Auricular acupunctureDEVICE

Auricular acupuncture with indwelling fixed needles at specific AA points

Auricular acupuncture
Sham auricular acupunctureDEVICE

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

Sham auricular acupuncture

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsAuriculotherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 14, 2017

Study Start

October 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 14, 2017

Record last verified: 2017-04