Acupuncture for Pain Control After Ambulatory Knee Arthroscopy

Overview

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

Full Title of Study: “Acupuncture vs. Standard Therapy for Treatment of Postoperative Pain in Patients Scheduled for Arthroscopic Knee Surgery – a Pilot Non-randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Acupuncture
    • 30 patients will receive acupuncture additionally to standard pharmacological therapy of postoperative pain
  • No Intervention: No intervention
    • 30 patients will receive just standard pharmacological therapy of postoperative pain

Clinical Trial Outcome Measures

Primary Measures

  • Analgesic requirement
    • Time Frame: 10 days
    • Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery

Secondary Measures

  • Pain intensity: verbal rating scale
    • Time Frame: 10 days after surgery
    • Pain intensity measured using verbal rating scale from 0=no pain to 10=maximal pain
  • Side affects
    • Time Frame: 10 days after surgery
    • Incidence of analgesic induced side effects

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University Medicine Greifswald
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Taras Usichenko, MD, PhD, Study Chair, Dept. of Anesthesiology
  • Overall Contact(s)
    • Taras Usichenko, MD, PhD, 00490383486, taras@uni-greifswald.de

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