About this trial
Prostate biopsy is the gold standard for the diagnosis of prostate cancer, and transperineal puncture is a common approach. It has the advantages of no bowel preparation and relative safety. At present, transperineal puncture is often performed under local anesthesia, but there are still clinical problems such as pain and anxiety for patients. Electroacupuncture is often used as an auxiliary means of local anesthesia in China, which has the advantages of analgesia and anti-anxiety. This study was conducted to evaluate the efficacy and safety of electroacupuncture combined with local anesthesia in transperineal needle biopsy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
(1) in the stage of acute genitourinary infection or fever. (2) patients with chronic pain (such as bone metastasis of prostate cancer, knee osteoarthritis, scapulohumeral periarthritis, etc.) or acute pain (tonsillitis, acute lumbar sprain, etc.) before surgery.
Trial design
Parallel
Treatments tested in this trial
electroacupuncture
Other interventionSterile acupuncture needles (Huatuo brand, specification: 0.25mm\*40mm) were applied to Hegu (Li4), Neiguan (PC 6), Guanyuan (CV 4) and Sanyinjiao (SP 6) by twidling, rotating, lifting and thrusting for 30 seconds. After getting qi (a feeling of acid, numbness, weight and swelling), the electronic acupuncture instrument (SDZ-II type, Huatuo brand) was connected, and the continuous wave was 50HZ. The current intensity was 1-5mA (preferably as much as the patient could tolerate without pain).
Sham-electroacupunture
Other interventionSham electroacupuncture was applied at the non-meridian and non-acupoint sites 3mm apart from the acupoints in the experimental group. The acupuncture method was shallow acupuncture, only 1-4mm through the skin.
Treatment groups
Trial outcomes
Primary outcomes
The maximum pain level
Use Numerical Rating Scale to Assess the maximum pain level during the operation,0-100mm,higher scores mean a worse outcome.
Secondary outcomes
Area under the curve for cumulative pain scores
Use Numerical Rating Scale to Assess the maximum pain level in 1h-24h after after the completion of surgery
Visual Analogue Scale for anxiety
Visual Analogue Scale for anxiety, 0-10,higher scores mean a worse outcome.
Incidence of rescue analgesia and total number of rescue analgesia
Incidence and number
Blood pressure
Blood pressure
Locations
Sponsors and contacts
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