Influence of Opioid Analgesia on Circulating Tumor Cells in Open Colorectal Cancer Surgery (POACC-1)

The Institute of Molecular and Translational Medicine, Czech Republic

Status and phase: Completed; Phase 4

Conditions: Circulating Tumor Cell; Colorectal Cancer

Treatments: Drug: Epidural; Drug: Piritramid; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT03700411

POACC-1

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• contraindications to epidural analgesia
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 3 patient groups

Morphine

Active Comparator group

Description:

Morphine-based perioperative analgesia

Treatment:

Drug: Morphine

Piritramid

Active Comparator group

Description:

Piritramid-based perioperative analgesia

Treatment:

Drug: Piritramid

Epidural

Active Comparator group

Description:

Perioperative epidural analgesia containing an opioid

Treatment:

Drug: Epidural