NCT01367418

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

May 26, 2011

Last Update Submit

March 16, 2012

Conditions

Prostate Cancer

Keywords

Analgesia: Thoracic epidural, patient controlledSurgery: Radical retropubic prostatectomyImmune systemInflammation

Outcome Measures

Primary Outcomes (1)

  • Natural Killer Cell activity

    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

    24 h postoperative

Secondary Outcomes (4)

  • IL-2

    24 h postoperatively

  • IL-6

    24 h postoperatively

  • TNF alpha

    24 h postoperatively

  • Serum cortisol

    0 h postoperatively

Study Arms (2)

Thoracic Epidural Analgesia (TEA)

EXPERIMENTAL

TEA is used for perioperative pain management, having been used both intra- and postoperatively, up to 48 h.

Drug: Thoracic Epidural Analgesia (TEA)

Patient controlled analgesia (PCA)

ACTIVE COMPARATOR

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)

Interventions

Patient controlled analgesia (PCA)DRUG

Morphine 1 mg/ml

Also known as: Morphine = morphine
Patient controlled analgesia (PCA)
Thoracic Epidural Analgesia (TEA)DRUG

Intra-operatively: Bupivacaine 0.5% with adrenaline Post-operatively: Ropivacaine 0.2% + sufentanil 1 ug

Also known as: Bupivacaine = Marcain, Ropivacaine = Narop, Sufentanil = Sufenta
Thoracic Epidural Analgesia (TEA)

Eligibility Criteria

Age50 Years - 78 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA physical status 1-2
  • Radical retropubic prostatectomy

You may not qualify if:

  • Chronic use of opiates
  • Contraindication to epidural analgesia
  • Allergy to component drugs
  • Chronic inflammatory diseases
  • Use of steroids perioperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

Prostatic NeoplasmsInflammation

Interventions

Analgesia, Patient-ControlledMorphineTeaSufentanil

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and AnalgesiaMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsPlant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesFentanylPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Anil Gupta, MD PhD

    Orebro University, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2011

First Posted

June 7, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations

SE(1)