We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01367418
Recruitment Status : Completed
First Posted : June 7, 2011
Last Update Posted : March 19, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Prostate Cancer Drug: Patient controlled analgesia (PCA) Drug: Thoracic Epidural Analgesia (TEA) Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison Between Epidural and Patient Controlled Analgesia on Immunological and Inflammatory Systems Following Radical Retropubic Prostatectomy
Study Start Date : September 2010
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Natural Killer Cell activity [ Time Frame: 24 h postoperative ]
    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 :
  1. IL-2 [ Time Frame: 24 h postoperatively ]
    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

  2. IL-6 [ Time Frame: 24 h postoperatively ]
    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

  3. TNF alpha [ Time Frame: 24 h postoperatively ]
    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

  4. Serum cortisol [ Time Frame: 0 h postoperatively ]
    Serum cortisol is a marker for stress response which is an important factor in immune response


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 78 Years   (Adult, Senior)
Sexes 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

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): 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

Responsible Party: Anil Gupta, Associate Professor, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01367418     History of Changes
Other Study ID Numbers: 20110601
First Posted: June 7, 2011    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Bupivacaine
Ropivacaine
Sufentanil
Morphine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General