Acupuncture for Pain Control After Ambulatory Knee Arthroscopy (AcuK-Scope)

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

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

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Knee Arthroscopy; Acupuncture
• Intervention / Treatment: Other: Acupuncture

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Vorpommern
    • Greifswald, Vorpommern, Germany, 17475
      • Recruiting
      • University Medicine of Greifswald
      • Contact: Taras Usichenko, MD. PhD; Phone Number: 5893 00490383486; Email: taras@uni-greifswald.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; 30 patients will receive acupuncture additionally to standard pharmacological therapy of postoperative pain	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
No Intervention: No intervention; 30 patients will receive just standard pharmacological therapy of postoperative pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic requirement	Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery	10 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Investigators: Study Chair: Taras Usichenko, MD, PhD, Dept. of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 18, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 22, 2019

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: BB 079/18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request from study chair after publication of results
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No