AcuPro: Acupuncture With Press Tack Needles for Perioperative Pain After Open Radical Prostatectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Acu Arm press tack needle acupuncture (ACU) and routine postoperative analgesic care |
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).
|
| Sham Comparator: SHAM Arm press tack placebo acupressure (SHAM) and routine postoperative analgesic care |
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).
|
| No Intervention: CONTROL Arm Patients in the control group will receive only routine postoperative analgesic care |
Outcome Measures
Primary Outcome Measures
- 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
- Cumulative use (sum in mg) of routine postoperative analgesics [postoperative day three]
Cumulative use (sum in mg) of routine postoperative analgesics
- Time to first defecation following surgery [postoperative day three]
Time to first defecation following surgery
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males aged 18-70 years
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Diagnosis with prostate cancer and scheduled for open radical prostatectomy
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Ability and willingness to follow study instructions and complete all required questionnaires during hospitalization and follow-up
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Written informed consent
Exclusion Criteria:
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Inability to understand the terms of this study
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Simultanously participation in other clinical trials possibly influencing primary or secondary endpoints or any acupuncture-related clinical trials within 30 days prior to inclusion
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Prior surgery within the last three months
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Received acupuncture within 6 weeks before surgery
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Known hypersensitivity or fear of acupuncture
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Known abuse of drugs, medications and alcohol
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Chronic pain for more than 3 months
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Continuous opioid analgesic medications for more than 3 days during the 4 weeks prior to surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Martini-Klinik am UKE GmbH | Hamburg | Germany | 20246 |
Sponsors and Collaborators
- Martini-Klinik am UKE GmbH
- Seirin Corporation, Shizuoka City, Japan
Investigators
- Principal Investigator: Hans Heinzer, Prof., Vice Medical Director and Faculty member of Martini-Klinik
Study Documents (Full-Text)
More Information
Publications
None provided.- AcuPro 09.2019
- DRK S00019884