Acupuncture for Pain Control After Ambulatory Knee Arthroscopy

Postoperative Pain; Knee Arthroscopy; Acupuncture Clinical Trial

— AcuK-Scope  

Official title:

Acupuncture vs. Standard Therapy for Treatment of Postoperative Pain in Patients Scheduled for Arthroscopic Knee Surgery - a Pilot Non-randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04134702
• Other study ID #: BB 079/18
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2021
• Source: University Medicine Greifswald
• Contact: Taras Usichenko, MD, PhD
• Phone: 00490383486
• Email: taras[@]uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study: To investigate whether acupuncture with indwelling fixed needles reduces pain and analgesic requirement and foster mobilization in patients after arthroscopic knee surgery (AKS) Design: Prospective pilot investigation with non-randomized arm Number of patients: N = 60 (30 patients with acupuncture additional to standard pain treatment (SPT) vs. 30 patients with SPT only Inclusion criteria: Adult patients scheduled to elective AKS in general anaesthesia with < 80 min. duration Without previous opioid and psychotropic medication Given informed consentOutcome measures: Postoperative analgesic requirement; Pain intensity; Incidence of side effects; Physiological parameters; Mobilization score

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

Inclusion Criteria:

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

2. Surgery time does not exceed 80 minutes

3. Patients without previous opioid and psychotropic medication

4. Patients aged between 19 and 55 years, able to fill in the study questionnaire (Appendix F)

5. Patients who have given written informed consent

Exclusion Criteria:

1. Current psychiatric disease

2. Local skin infection at the sites of acupuncture

3. Aged < 19 or > 55 years

4. Failure to follow the standardized schema of general anaesthesia

5. Surgery time more than 80 minutes

6. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)

7. Patients who consumed opioid medication at least 6 months before surgery

8. Patients who are unable to understand the consent form or to fill in the study questionnaire.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain; Knee Arthroscopy; Acupuncture

Intervention

Other:
• Acupuncture
Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain

Locations

Country	Name	City	State
Germany	University Medicine of Greifswald	Greifswald	Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic requirement	Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery	10 days
Secondary	Pain intensity: verbal rating scale	Pain intensity measured using verbal rating scale from 0=no pain to 10=maximal pain	10 days after surgery
Secondary	Side affects	Incidence of analgesic induced side effects	10 days after surgery