Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery

NCT02314871 | Completed Phase 4

• 1 other identifier: CAREC-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to compare the effects of three types of perioperative analgesia on the number of circulating cancer cells (representing minimal residual disease) following radical colon cancer surgery. Patients will be randomized into one of three groups. The intervention group will receive combined regional and general anesthesia during surgery and postoperative epidural analgesia. The two control groups will receive balanced general anesthesia and either morphine-based or piritramide-based postoperative analgesia. We hypothesize that epidural analgesia will be favorable to both piritramide-based and morphine-based analgesia and that piritramide-based analgesia will be favorable to morphine-based analgesia with regard to the number of circulating cancer cells and its development in the early postoperative period.

Conditions

Colon Cancer; Minimal Residual Disease

Keywords

perioperative analgesia; minimal residual disease; cancer recurrence; epidural; morphine; piritramide; colon; cancer; circulating cancer cells; colon cancer surgery

Outcome Measures

Primary Outcomes (1)

• Change from baseline number of circulating cancer cells at 3 weeks after surgery

  Number of circulating cancer cells will be measured in venous blood samples. The quantitative real-time polymerase chain reaction using carcinoembryonic antigen and cytokeratine 20 as markers for circulating cancer cells will be used for minimal residual disease detection.

  Baseline prior to surgery, on day 2 postoperatively and three weeks after surgery

Secondary Outcomes (1)

• Pain intensity assessment

  3 days postoperatively

Study Arms (3)

Epidural

ACTIVE COMPARATOR

Patients will receive perioperative epidural analgesia. Drugs: bupivacaine 1.25 mg/ml and sufentanil 0.5 mcg/ml Form and frequency: continuous infusion Dosage: 4 - 14 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required

Other: Epidural analgesia

Piritramide

ACTIVE COMPARATOR

Patients will receive postoperative analgesia with piritramide. Drugs: piritramide 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required

Drug: Piritramide

Morphine

ACTIVE COMPARATOR

Patients will receive postoperative analgesia with morphine. Drugs: morphine 1.0 mg/ml Form and frequency: continuous infusion Dosage: 0 - 4 ml/h with boluses 2 - 4 ml based on pain assessment Duration: as long as required

Drug: Morphine

Interventions

Epidural analgesia OTHER

see Arm/group description

Also known as: Perioperative epidural analgesia

Epidural

Piritramide DRUG

see Arm/group description

Also known as: Postoperative piritramide analgesia

Piritramide

Morphine DRUG

see Arm/group description

Also known as: Postoperative morphine analgesia

Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing open radical surgery for colon cancer (without known extension beyond colon)
• Age over 18 years
• Written informed consent

You may not qualify if:

• Allergy or intolerance of morphine, piritramide, marcaine, sufentanil or volatile anesthetics
• History of colon cancer resection
• Other cancer present (apart from those in complete long-term remission for minimum 6 months)
• Chronic opioid medication and/or opioid administration 7 days or less prior to surgery
• Any contraindication to thoracic epidural anesthesia/analgesia
• Systemic therapy with immunosuppressive drugs or corticoids (apart from topical and inhalational)
• Any surgery within the last 30 days (apart from minor day-case procedures)  - Chronic or acute infectious disease, particularly hepatitis, AIDS, tuberculosis

Sponsors & Collaborators

• The Institute of Molecular and Translational Medicine, Czech Republic: lead
• Brno University Hospital: collaborator
• Tomas Bata Hospital, Czech Republic: collaborator

Study Sites (2)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

T. Bata Regional Hospital Zlin

Zlin, South Moravian, 76275, Czechia

Location

Related Links

• The Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry Palacky University Olomouc

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasm, Residual; Neoplasms

Interventions

Analgesia, Epidural; Pirinitramide; Morphine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Emil Berta, MD PhD

  The Institute of Molecular and Translational Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 11, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

CZ (2)