Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy

Postoperative Pain Clinical Trial

Official title:

Auricular Acupuncture Versus Placebo (Sham Acupuncture) for Postoperative Pain Relief After Ambulatory Knee Arthroscopy - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233857
• Other study ID #: III UV 23/03
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 5, 2005
• Last updated: February 25, 2011
• Start date: August 2003
• Est. completion date: August 2004

Study information

• Verified date: February 2011
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia.

2. Surgery time does not exceed 60 minutes.

3. Patients without previous opioid and/or psychiatric medication.

4. Patients ranged 16-65 years old.

5. Patients able to use Visual Analogue Scale-100 for pain intensity measurement.

6. Patients who have given informed consent.

Exclusion Criteria:

1. Pregnant or nursing females.

2. Recidivist alcoholics and/or patients with history of psychiatric disease.

3. Local or systemic infection.

4. Age < 16 and > 65 years.

5. Surgery time more than 60 minutes.

6. Inability to use Visual Analogue Scale-100.

7. Patients consumed opioid medication before surgery.

8. Patients with prosthetic or damaged cardiac valves (s. Potential risks)

9. Patients who are unable to understand the consent form.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Auricular acupuncture

Locations

Country	Name	City	State
Germany	Anesthesiology and Intensive Care Medicine Department, University of Greifswald, Germany	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative ibuprofen requirement after the surgery
Secondary	Pain intensity assessed by patients on VAS-100 ; total piritramide requirement in anesthesia recovery room; incidence of analgesia-related side effects