Acupuncture for Pain Control After Ambulatory Knee Arthroscopy

Study Overview
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Brief Summary
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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

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

Conditions
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Postoperative Pain; Knee Arthroscopy; Acupuncture

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>30 patients will receive acupuncture additionally to standard pharmacological therapy of postoperative pain | Other: Acupuncture<br>* Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain<br>|
| No Intervention: No intervention<br>30 patients will receive just standard pharmacological therapy of postoperative pain | |

What is the study measuring?
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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 |