Postoperative Pain
Conditions
Brief summary
Aim of the study To investigate whether auricular acupuncture (AA) will reduce postoperative pain and analgesic requirement in comparison with sham AA in patients after elective knee arthroplasty Design Prospective randomized controlled blinded clinical trial Participants: * Patients \< 80 und \> 50 years old * scheduled for knee arthroplasty under general anesthesia with \< 120 minutes duration * Without previous opioid medication * Able to give informed consent Outcome measures * Postoperative analgesic requirement * Incidence of side effects * Physiological parameters
Interventions
DEVICEAuricular acupuncture
Auricular acupuncture with indwelling fixed needles at specific AA points
Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points
Sponsors
Naemi-Wilke-Stift Guben Hospital - Anesthesia Services
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with an American Society of Anesthesiologists physical status of I to III scheduled for elective knee arthroplasty under general anesthesia 2. Surgery time does not exceed 120 minutes 3. Patients without previous opioid medication 4. Patients ranged 50-80 years old 5. Patients who have given written informed consent
Exclusion criteria
1. Recidivist alcoholics 2. Local auricular skin infection 3. Age \< 50 and \> 80 years 4. Surgery time more than 120 minutes 5. Intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines) 6. Patients who consumed opioid medication at least 6 months before surgery 7. Patients with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of AHA) 8. Patients who are unable to understand the consent form 9. History of psychiatric disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative requirement of analgesic tilidine (measured in mg) | Six days following surgery | Requirement of opioid analgesic tilidin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effects of analgesics | Six days following surgery | Incidence of nausea and vomiting |
| heart rate | 12 hours after surgery | heart rate |
| blood pressure | 12 hours following surgery | blood pressure |
| Patients' satisfaction with the treatment of postoperative pain using NRS-5 (where 1=excellent; 5=very bad) | 12 hours following surgery | — |
Outcome results
None listed