Postoperative PainPhase 2/3NCT00233857
Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy
A Phase 2/3 study testing Auricular acupuncture in people with Postoperative Pain, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Auricular acupuncture
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2003to Aug 2004
- Phase
- Phase 2/3
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia.
- Surgery time does not exceed 60 minutes.
- Patients without previous opioid and/or psychiatric medication.
- Patients ranged 16-65 years old.
- Patients able to use Visual Analogue Scale-100 for pain intensity measurement.
- Patients who have given informed consent.
Who cannot join
- Pregnant or nursing females.
- Recidivist alcoholics and/or patients with history of psychiatric disease.
- Local or systemic infection.
- Age < 16 and > 65 years.
- Surgery time more than 60 minutes.
- Inability to use Visual Analogue Scale-100.
Show all 9Show fewer
- Patients consumed opioid medication before surgery.
- Patients with prosthetic or damaged cardiac valves (s. Potential risks)
- Patients who are unable to understand the consent form.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
Greifswald, 17487
About this study
Official title: Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial
The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy
- Conditions
- Postoperative Pain
- Being tested
- Auricular acupuncture
- Keywords
- Acute pain, postoperative pain, auricular acupuncture
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupunctureProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ibuprofen requirement after the surgery
Secondary outcomes (1)
Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startAug 2003
- Primary completionJul 2004
- Study completionAug 2004
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Investigators
- Taras I. Usichenko, Assistant Professor, Principal investigator, Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233857
- Sponsor's protocol ID
- III UV 23/03
- Status last verified
- Feb 2011
- First submitted
- 5 Oct 2005
- Last updated
- 28 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00233857
- Acronym / sponsor ID
- III UV 23/03
- Conditions
- Postoperative Pain
- Keywords
- Acute pain, postoperative pain, auricular acupuncture
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jul 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 6 Oct 2005 (estimated)
- 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.
The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia.
- Surgery time does not exceed 60 minutes.
- Patients without previous opioid and/or psychiatric medication.
- Patients ranged 16-65 years old.
- Patients able to use Visual Analogue Scale-100 for pain intensity measurement.
Key exclusion criteria (9 listed)
- Pregnant or nursing females.
- Recidivist alcoholics and/or patients with history of psychiatric disease.
- Local or systemic infection.
- Age < 16 and > 65 years.
- Surgery time more than 60 minutes.
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 acupuncture | Procedure or surgery | – |
Primary outcome
Postoperative ibuprofen requirement after the surgery
1 secondary outcome
Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects
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 28 Feb 2011.
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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.
Taras I. Usichenko, Assistant Professor principal investigator
Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Auricular acupuncture in people with Postoperative Pain, run by University Medicine Greifswald at 1 site in Germany.
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 6 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 28 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 ibuprofen requirement after the 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 28 Feb 2011.