Postoperative PainAA_K-TEPNCT03114449
Auricular Acupuncture vs. Sham Procedure for Pain Control After Knee Arthroplasty
A study testing Auricular acupuncture in people with Postoperative Pain, run by University Medicine Greifswald.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Auricular acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial
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
- Conditions
- Postoperative Pain
- Being tested
- Auricular acupuncture, Sham auricular acupuncture
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureDevice
Auricular acupuncture with indwelling fixed needles at specific AA points
Sham auricular acupunctureDevice
Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupuncture | Experimental | Auricular acupuncture (AA) with indwelling fixed needles at specific AA points Receives: Device: Auricular acupuncture |
| Sham auricular acupuncture | Sham comparator | Sham auricular acupuncture with indwelling fixed needles at non- AA points Receives: Device: Sham auricular acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative requirement of analgesic tilidine (measured in mg)
Requirement of opioid analgesic tilidin
Measured: Six days following surgery
Secondary outcomes (4)
Side effects of analgesics
Incidence of nausea and vomiting
Measured: Six days following surgery
heart rate
heart rate
Measured: 12 hours after surgery
blood pressure
blood pressure
Measured: 12 hours following surgery
Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)
Measured: 12 hours following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study startOct 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- Naemi-Wilke-Stift Guben Hospital - Anesthesia Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03114449
- Sponsor's protocol ID
- BB 102/11
- Acronym
- AA_K-TEP
- Status last verified
- Apr 2017
- First submitted
- 3 Apr 2017
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture (AA) vs. Sham AA Procedure for Pain Control After Elective Knee Arthroplasty - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03114449
- Acronym / sponsor ID
- AA_K-TEP / BB 102/11
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- Naemi-Wilke-Stift Guben Hospital - Anesthesia Services
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupuncture | Experimental | Device: Auricular acupunctureAuricular acupuncture (AA) with indwelling fixed needles at specific AA points |
| Sham auricular acupuncture | Sham comparator | Device: Sham auricular acupunctureSham auricular acupuncture with indwelling fixed needles at non- AA points |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupunctureAuricular acupuncture with indwelling fixed needles at specific AA points | Device | Auricular acupuncture |
| Sham auricular acupunctureSham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points | Device | Sham auricular acupuncture |
Primary outcome
Postoperative requirement of analgesic tilidine (measured in mg)
Time frame: Six days following surgery
Requirement of opioid analgesic tilidin
4 secondary outcomes
Side effects of analgesics
Time frame: Six days following surgery
heart rate
Time frame: 12 hours after surgery
blood pressure
Time frame: 12 hours following surgery
Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad)
Time frame: 12 hours following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Pain
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
Active, not recruiting
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupuncture in people with Postoperative Pain, run by University Medicine Greifswald.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative requirement of analgesic tilidine (measured in mg) (time frame: Six days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.