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Clinical Trials/NCT04134702
NCT04134702
Unknown
Not Applicable

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

University Medicine Greifswald1 site in 1 country60 target enrollmentFebruary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain; Knee Arthroscopy; Acupuncture
Sponsor
University Medicine Greifswald
Enrollment
60
Locations
1
Primary Endpoint
Analgesic requirement
Last Updated
5 years ago

Overview

Brief 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

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Medicine Greifswald
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with an American Society of Anesthesiologists physical status of I to II scheduled for elective ambulatory arthroscopic knee surgery under standardized general anesthesia
  • Surgery time does not exceed 80 minutes
  • Patients without previous opioid and psychotropic medication
  • Patients aged between 19 and 55 years, able to fill in the study questionnaire (Appendix F)
  • Patients who have given written informed consent

Exclusion Criteria

  • Current psychiatric disease
  • Local skin infection at the sites of acupuncture
  • Aged \< 19 or \> 55 years
  • Failure to follow the standardized schema of general anaesthesia
  • Surgery time more than 80 minutes
  • Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines)
  • Patients who consumed opioid medication at least 6 months before surgery
  • Patients who are unable to understand the consent form or to fill in the study questionnaire.

Outcomes

Primary Outcomes

Analgesic requirement

Time Frame: 10 days

Total dose of ibuprofen taken by the patient during 10 days after arthroscopic knee surgery

Secondary Outcomes

  • Pain intensity: verbal rating scale(10 days after surgery)
  • Side affects(10 days after surgery)

Study Sites (1)

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