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

Not Applicable

Completed

• Conditions: Prostate Cancer; Perioperative Pain
• Interventions: Other: Acupuncture; Other: Acupressure

• Registration Number: NCT04172649
• Lead Sponsor: Martini-Klinik am UKE GmbH

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).

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Study Start: 2020-03-01
• Primary Completion: 2021-04-09
• Study Completion: 2021-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acu Arm	Acupuncture	press tack needle acupuncture (ACU) and routine postoperative analgesic care
SHAM Arm	Acupressure	press tack placebo acupressure (SHAM) and routine postoperative analgesic care

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)	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 Outcome Measures

Name	Time	Method
EQ-5D-5L for quality of life	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.
Time to first defecation following surgery	postoperative day three	Time to first defecation following surgery
Cumulative use (sum in mg) of routine postoperative analgesics	postoperative day three	Cumulative use (sum in mg) of routine postoperative analgesics

Trial Locations

Locations (1)

Martini-Klinik am UKE GmbH; 🇩🇪 Hamburg, Germany