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NCT Number: NCT04172649

Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy

Acupuncture has been shown in several meta-analyses and clinical studies, in different surgical settings and chronic back pain, to be a safe adjuvant option for postoperative pain treatment. In this study, the investigator hypothesize that acupuncture can decrease postoperative pain intensity and amount of given analgesics, and accelerate recovery of bowel motility, in patients after open radical prostatectomy.

The investigator will also investigate whether or not acupuncture with needle skin penetration is more efficacious than acupressure.

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Key information

Conditions

Prostate Cancer Agnosia Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Perioperative Pain Prostatic Diseases Prostatic Neoplasms Signs and Symptoms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Martini-Klinik am UKE GmbH

Hamburg, 20246, Germany

About this study

This study will be a randomized, controlled and partially blinded study with three arms: 1) press tack needle acupuncture (ACU) and routine postoperative analgesic care, 2) press tack placebo acupressure (SHAM) and routine postoperative analgesic care, and 3) only routine postoperative analgesic care (CONTROL).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males aged 18-70 years
  • Diagnosis with prostate cancer and scheduled for open radical prostatectomy
  • Ability and willingness to follow study instructions and complete all required questionnaires during hospitalization and follow-up
  • Written informed consent

Exclusion criteria

  • Inability to understand the terms of this study
  • Simultanously participation in other clinical trials possibly influencing primary or secondary endpoints or any acupuncture-related clinical trials within 30 days prior to inclusion
  • Prior surgery within the last three months
  • Received acupuncture within 6 weeks before surgery
  • Known hypersensitivity or fear of acupuncture
  • Known abuse of drugs, medications and alcohol
  • Chronic pain for more than 3 months
  • Continuous opioid analgesic medications for more than 3 days during the 4 weeks prior to surgery

Treatment and study plan

Acupuncture

Other

On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack needles (diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).

Acupressure

Other

On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack placebos (knob without needle, diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).

Primary outcomes

  1. Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)

    Time frame: postoperative day three

    The primary outcome is to check the effects of permanent needle acupuncture at 6 acupuncture points for changing postoperative pain intensity as measured by the Numeric Rating Scale (NRS-11), calculated as area under the curve (AUC).

Secondary outcomes

  1. Cumulative use (sum in mg) of routine postoperative analgesics

    Time frame: postoperative day three

    Cumulative use (sum in mg) of routine postoperative analgesics

  2. Time to first defecation following surgery

    Time frame: postoperative day three

    Time to first defecation following surgery

  3. EQ-5D-5L for quality of life

    Time frame: 7 days after catheter removal

    fill out a questionnaire: According to the website httpp://euroqol.org/eq-5d-instruments/eq-5d-5l-about/ under the tab "User guide 5L", page 5 in a blue box, it states that EQ-5D-5L is not an abbreviation and should be used and quoted as is. The EQ-5D-5L questionnaire measures quality of life based on 5 different levels (no problems, slight problems, moderate problems, severe problems and extreme problems) to each of the following dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

Sponsors and collaborators

Lead sponsor

Martini-Klinik am UKE GmbH

Other

Collaborators

  • Seirin Corporation, Shizuoka City, Japan

Registry information

Official study title

A Randomized Controlled Study on Acupuncture for Perioperative Pain After Open Radical Prostatectomy

Acronym: AcuPro

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 21, 2019
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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