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Trial record 4 of 21 for:    piritramid

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

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ClinicalTrials.gov Identifier: NCT02314871
Recruitment Status : Recruiting
First Posted : December 11, 2014
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
Brno University Hospital
Tomas Bata Hospital, Czech Republic
Information provided by (Responsible Party):
Emil Berta, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Minimal Residual Disease Other: Epidural analgesia Drug: Piritramide Drug: Morphine Phase 4

Detailed Description:

Techniques of regional analgesia such as epidural analgesia may favorably influence metastasis development following cancer surgery compared to analgesia based on strong opioids such as morphine or piritramide. These beneficial effects, if present, are probably attributable to less immunosuppression of antimetastatic immune defenses.

The aim of this study is to identify techniques of perioperative analgesia with the potential to prevent metastasis development in patients undergoing open radical colon cancer surgery. In the early postoperative period, a relationship between metastasis development and the number of circulating cancer cells representing minimal residual disease has been shown. Therefore, effects of epidural, morphine-based and piritramide-based analgesia on the number of circulating cancer cells will be compared at several time points during the peroperative and early postoperative periods. The number of circulating cancer cells will be assessed in peripheral venous blood samples using real-time polymerase chain reaction. Perioperative care will be standardized and patients will be followed by clinical observation, laboratory analyses and monitoring instrumentation daily during their hospital stay.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Different Types of Perioperative Analgesia on Minimal Residual Disease Development After Colon Cancer Surgery
Study Start Date : January 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : September 2018

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U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Epidural
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
see Arm/group description
Other Name: Perioperative epidural analgesia
Active Comparator: Piritramide
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
see Arm/group description
Other Name: Postoperative piritramide analgesia
Active Comparator: Morphine
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
see Arm/group description
Other Name: Postoperative morphine analgesia



Primary Outcome Measures :
  1. Change from baseline number of circulating cancer cells at 3 weeks after surgery [ Time Frame: Baseline prior to surgery, on day 2 postoperatively and three 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.


Secondary Outcome Measures :
  1. Pain intensity assessment [ Time Frame: 3 days postoperatively ]
    Self reported pain intensity. Scale: 0 = no pain, 10 = worst pain imaginable. A score 0-10 will be recorded every four hours.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314871


Contacts
Contact: Emil Berta, MD PhD 00420608801303 e.berta@email.cz
Contact: Josef Srovnal, MD PhD 00420585632111 srovnalj@upol.cz

Locations
Czech Republic
Brno University Hospital Recruiting
Brno, Jihomoravsky kraj, Czech Republic, 62500
Contact: Petr Stourac, MD, PhD    +420532233850    stouracp@fnbrno.cz   
T. Bata Regional Hospital Zlin Recruiting
Zlin, Jihomoravsky kraj, Czech Republic, 76275
Contact: Tomas Gabrhelik, MD, PhD    +420577552280    Tomas.Gabrhelik@bnzlin.cz   
Sponsors and Collaborators
The Institute of Molecular and Translational Medicine, Czech Republic
Brno University Hospital
Tomas Bata Hospital, Czech Republic
Investigators
Principal Investigator: Emil Berta, MD PhD The Institute of Molecular and Translational Medicine

Additional Information:
Responsible Party: Emil Berta, M.D., Ph.D., Senior Researcher, The Institute of Molecular and Translational Medicine, Czech Republic
ClinicalTrials.gov Identifier: NCT02314871     History of Changes
Other Study ID Numbers: CAREC-1
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Emil Berta, M.D., Ph.D., The Institute of Molecular and Translational Medicine, Czech Republic:
perioperative analgesia
minimal residual disease
cancer recurrence
epidural
morphine
piritramide
colon
cancer
circulating cancer cells
colon cancer surgery

Additional relevant MeSH terms:
Pirinitramide
Colonic Neoplasms
Neoplasm, Residual
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Neoplastic Processes
Pathologic Processes
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents