Auricular Acupuncture for Pain Relief After Ambulatory Kn... | NCT00233857

Studies
Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy

NCT00233857

Sponsor

University Medicine Greifswald

Status

Completed

Last Update Posted

Feb 28, 2011Estimated

Enrollment

120

Phase

Phase 2Phase 3

Conditions

Postoperative Pain

Interventions

Auricular acupuncture

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Jul 2004Actual

Completion Date

Aug 2004Actual

First Submitted Date

Oct 5, 2005

First Submission Date that Met QC Criteria

Oct 5, 2005

First Posted Date

Oct 6, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2011

Last Update Posted Date

Feb 28, 2011Estimated

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Auricular acupuncture	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative ibuprofen requirement after the surgery

Secondary Outcomes

Measure	Description	Time Frame
Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Taras I. Usichenko, Assistant Professor	Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany		Greifswald		17487	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D059787	Acute Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020831	Acupuncture, Ear

Ancestor Terms

ID	Term
D015670	Acupuncture Therapy
D000529	Complementary Therapies
D013812	Therapeutics
D055097	Auriculotherapy

Browse Leaves

Not provided

Browse Branches

Not provided