Influence of Peri-operative Opioid Analgesia on Circulating Tumor Cells in Patients Undergoing Laparoscopic Colorectal Cancer Surgery - Multi-center, Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 71
- Locations
- 3
- Primary Endpoint
- Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
Study Overview
Brief Summary
To compare the effects of three types of perioperative analgesia on the number of circulating tumor cells following radical colorectal cancer surgery. To find correlations with other perioperative factors and clinical/pathological disease characteristics.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients undergoing open radical surgery for colorectal cancer
- •age over 18 years
- •signed informed consent
Exclusion Criteria
- •intolerance of the study drugs
- •history of CRC surgery
- •neoadjuvant therapy
- •other malignancy not in permanent remission
- •chronic opioid medication or opioid administration within 7 days preoperatively
- •immunosuppressive or corticosteroid therapy
- •surgery within 30 days preoperatively (except minor)
- •chronic or acute infection
Arms & Interventions
Morphine
Morphine-based perioperative analgesia
Intervention: Morphine (Drug)
Piritramid
Piritramid-based perioperative analgesia
Intervention: Piritramid (Drug)
Outcomes
Primary Outcomes
Change in number of circulating tumor cells prior to surgery to 2 - 4 weeks after surgery
Time Frame: 1 - 3 days before surgery to 4 weeks after surgery
Baseline number of circulating tumor cells will be recorded prior to surgery in a venous blood sample. Number of circulating tumor cells will be measured 2 - 4 weeks after surgery in a venous blood sample. These two values will be compared.
Secondary Outcomes
- Pain assessment(Time Frame: 3 days postoperatively)