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

Martini-Klinik am UKE GmbH

Status: Completed

Conditions: Perioperative Pain; Prostate Cancer

Treatments: Other: Acupuncture; Other: Acupressure

Study type: Interventional

Funder types: Other

Identifiers

NCT04172649

AcuPro 09.2019

DRK S00019884 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 126 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

126 participants in 3 patient groups

Acu Arm

Experimental group

Description:

press tack needle acupuncture (ACU) and routine postoperative analgesic care

Treatment:

Other: Acupuncture

SHAM Arm

Sham Comparator group

Description:

press tack placebo acupressure (SHAM) and routine postoperative analgesic care

Treatment:

Other: Acupressure

CONTROL Arm

No Intervention group

Description:

Patients in the control group will receive only routine postoperative analgesic care