NCT04172649

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Martini-Klinik am UKE GmbH · Academic / Other
• Sex: Male
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Prostate Cancer
• Perioperative Pain

Interventions

Type	Name	Description
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).
OTHER	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).

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-04-09
• Completion: 2021-12-31
• First posted: 2019-11-21
• Last updated: 2023-04-13

Locations

1 site across 1 country: Germany