Clinical trial NCT04172649: Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy
Official title: A Randomized Controlled Study on Acupuncture for Perioperative Pain After Open Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Perioperative Pain
Keywords: prostate cancer
pain management
acupuncture
acupressure
Lead sponsor: Martini-Klinik am UKE GmbH
Sponsor class: OTHER
Collaborators: name: Seirin Corporation, Shizuoka City, Japan
First posted: 2019-11-21
Enrollment: 126
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)
timeFrame: postoperative day three
Secondary outcomes:
measure: Cumulative use (sum in mg) of routine postoperative analgesics
timeFrame: postoperative day three
measure: Time to first defecation following surgery
timeFrame: postoperative day three
measure: EQ-5D-5L for quality of life
timeFrame: 7 days after catheter removal
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Martini-Klinik am UKE GmbH
Study officials:
affiliation: Vice Medical Director and Faculty member of Martini-Klinik
name: Hans Heinzer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: