Acupuncture for Pain Control After Ambulatory Knee Arthroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture.
- Who it may be relevant to
- Registry conditions: Postoperative Pain; Knee Arthroscopy; Acupuncture. Basic parameters: 19 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acupuncture vs. Standard Therapy for Treatment of Postoperative Pain in Patients Scheduled for Arthroscopic Knee Surgery - a Pilot Non-randomized Controlled Trial
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
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
Primary outcome measures
- Analgesic requirement [Time frame: 10 days]
Secondary outcome measures (2)
- Pain intensity: verbal rating scale [Time frame: 10 days after surgery]
- Side affects [Time frame: 10 days after surgery]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- University Medicine of Greifswald — Greifswald
Identifiers
NCT: NCT04134702 · BB 079/18