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

Prostate Cancer Clinical Trial

— AcuPro  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04172649
• Other study ID #: AcuPro 09.2019
• Secondary ID: DRK S00019884
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2023
• Source: Martini-Klinik am UKE GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 31, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Perioperative Pain
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Acupuncture
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
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).

Locations

Country	Name	City	State
Germany	Martini-Klinik am UKE GmbH	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Martini-Klinik am UKE GmbH	Seirin Corporation, Shizuoka City, Japan

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain intensity measured by Numeric Rating Scale (NRS-11)	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).	postoperative day three
Secondary	Cumulative use (sum in mg) of routine postoperative analgesics	Cumulative use (sum in mg) of routine postoperative analgesics	postoperative day three
Secondary	Time to first defecation following surgery	Time to first defecation following surgery	postoperative day three
Secondary	EQ-5D-5L for quality of life	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.	7 days after catheter removal