Effects of Anesthetic Technique on Immune and Inflammatory Systems Following Radical Prostatectomy (AIMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anil Gupta, Örebro University, Sweden
ClinicalTrials.gov Identifier:
NCT01367418
First received: May 26, 2011
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

Several recently published retrospective studies show that regional anaesthesia (RA) can reduce cancer-related mortality following surgical treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results are true, then the choice of perioperative pain management is as beneficial, or even better, than the current oncological therapies. This theory needs to be investigated in a prospective, randomized and controlled trail. We shall perform a prospective, randomized study comparing the effects of Thoracic epidural analgesia (TEA) or patient controlled analgesia (PCA) on postoperative immunological and inflammatory markers in order to understand whether the protective effects, if any, of regional analgesia are due to changes in these markers or whether the underlying mechanisms is not mediated via this stress signalling pathway.


Condition Intervention Phase
Prostate Cancer
Drug: Patient controlled analgesia (PCA)
Drug: Thoracic Epidural Analgesia (TEA)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Comparison Between Epidural and Patient Controlled Analgesia on Immunological and Inflammatory Systems Following Radical Retropubic Prostatectomy

Resource links provided by NLM:


Further study details as provided by Örebro University, Sweden:

Primary Outcome Measures:
  • Natural Killer Cell activity [ Time Frame: 24 h postoperative ] [ Designated as safety issue: No ]
    NK cells are of primary importance in the elimination of tumor target cells at the early stage of tumor development, up to and including tumor metastasis. Decreased NK cell function during the perioperative period is associated with an increased risk of mortality in cancer patients. The NK cell activity would be measured using a special assay called FANKIA


Secondary Outcome Measures:
  • IL-2 [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]
    Interleucine release is a response to injury and the amount of interleucine in the circulation is related to the degree of trauma. Intensity of trauma is in turn related to the degree of stress response, which is reduced by epidural analgesia

  • IL-6 [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]
    Interleucine release is a response to injury and the amount of interleucine in the circulation is related to the degree of trauma. Intensity of trauma is in turn related to the degree of stress response, which is reduced by epidural analgesia

  • TNF alpha [ Time Frame: 24 h postoperatively ] [ Designated as safety issue: No ]
    Interleucine release is a response to injury and the amount of interleucine in the circulation is related to the degree of trauma. Intensity of trauma is in turn related to the degree of stress response, which is reduced by epidural analgesia

  • Serum cortisol [ Time Frame: 0 h postoperatively ] [ Designated as safety issue: No ]
    Serum cortisol is a marker for stress response which is an important factor in immune response


Enrollment: 26
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thoracic Epidural Analgesia (TEA)
TEA is used for perioperative pain management, having been used both intra- and postoperatively, up to 48 h.
Drug: Thoracic Epidural Analgesia (TEA)
Intra-operatively: Bupivacaine 0.5% with adrenaline Post-operatively: Ropivacaine 0.2% + sufentanil 1 ug
Other Names:
  • Bupivacaine = Marcain
  • Ropivacaine = Narop
  • Sufentanil = Sufenta
Active Comparator: Patient controlled analgesia (PCA)
PCA is the standard of pain management and is usually used for up to 48 h postoperative for pain management following radical prostatectomy.
Drug: Patient controlled analgesia (PCA)
Morphine 1 mg/ml
Other Name: Morphine = morphine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 78 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA physical status 1-2
  • Radical retropubic prostatectomy

Exclusion Criteria:

  • Chronic use of opiates
  • Contraindication to epidural analgesia
  • Allergy to component drugs
  • Chronic inflammatory diseases
  • Use of steroids perioperatively
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01367418

Locations
Sweden
University Hospital
Örebro, Sweden, 701 85
Sponsors and Collaborators
Örebro University, Sweden
Investigators
Principal Investigator: Anil Gupta, MD PhD Orebro University, Sweden
  More Information

No publications provided

Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01367418     History of Changes
Other Study ID Numbers: 20110601
Study First Received: May 26, 2011
Last Updated: March 16, 2012
Health Authority: Örebro University, Sweden:

Keywords provided by Örebro University, Sweden:
Analgesia: Thoracic epidural, patient controlled
Surgery: Radical retropubic prostatectomy
Immune system
Inflammation

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bupivacaine
Ropivacaine
Sufentanil
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Analgesics
Narcotics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on July 20, 2014