Electroacupuncture in the Treatment of Patients Undergoing Transperineal Prostate Biopsy Under Local Anesthesia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorShanghai University of Traditional Chinese Medicine

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • electroacupuncture

    Other intervention

    Sterile 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 intervention

    Sham 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

190 Participants
are divided into 2 treatment groups
Group A: electroacupuntureExperimental treatment 1 intervention
Group B: Sham-electroacupuntureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
The end of the operation

Secondary outcomes

1

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

Time frame
1h、6h、24h after completion of surgery
2

Visual Analogue Scale for anxiety

Visual Analogue Scale for anxiety, 0-10,higher scores mean a worse outcome.

Time frame
At the beginning of operation and at the completion of operation
3

Incidence of rescue analgesia and total number of rescue analgesia

Incidence and number

Time frame
At the completion of operation
4

Blood pressure

Blood pressure

Time frame
At the completion of the operation and 20 min before the start of the operation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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