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Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Auricular acupuncture
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Acute pain, postoperative pain, auricular acupuncture

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany

Outcomes

Primary Outcome Measures

Postoperative ibuprofen requirement after the surgery

Secondary Outcome Measures

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

Full Information

First Posted
October 5, 2005
Last Updated
February 25, 2011
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT00233857
Brief Title
Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy
Official Title
Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Medicine Greifswald

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Acute pain, postoperative pain, auricular acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Auricular acupuncture
Primary Outcome Measure Information:
Title
Postoperative ibuprofen requirement after the surgery
Secondary Outcome Measure Information:
Title
Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taras I. Usichenko, Assistant Professor
Organizational Affiliation
Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany
City
Greifswald
ZIP/Postal Code
17487
Country
Germany

12. IPD Sharing Statement

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Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy

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