NCT00305136

Brief Summary

Recent advances in the field of pain psychophysics that have enhanced the understanding of pain processing by the nervous system seem to characterize the individual pattern of pain processing, thereby enabling the prediction of a person's susceptibility to develop chronic pain consequent to surgery. In this project, the researchers propose to apply a wide array of advanced testing methods in order to prospectively assess the pain modulation pattern of pain free patients about to undergo an elective thoracotomy. Since about half of post-thoracotomy patients suffer from chronic neuropathic postoperative pain, the researchers expect to identify which tests predict a risk for this pain and the relative power of the relevant tests in this prediction, and to construct a short and applicable tool, the 'pain susceptibility profile', that will reliably predict the risk for the development of pain. The expected results of this project will serve the field of pain prevention by identifying patients at risk and tailoring interventions to reduce the risk of chronic pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2005

Longer than P75 for all trials

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

December 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2006

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

4.1 years

First QC Date

March 19, 2006

Last Update Submit

October 10, 2017

Conditions

Keywords

thoracotomypost-operative painchronic painendogenous analgesiatemporal summationcentral sensitizationpredictionPatients Who Should Undergo Thoracotomy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inclusion Criteria: * Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases. Exclusion Criteria: * Psychiatric or cognitive dysfunction precluding use of psychophysics * Existing thoracic pain * Patients who cannot communicate in Hebrew

You may qualify if:

  • Pain free patients to undergo major thoracic operation with both malignant and non-malignant diseases.

You may not qualify if:

  • Psychiatric or cognitive dysfunction precluding use of psychophysics
  • Existing thoracic pain
  • Patients who cannot communicate in Hebrew

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Medical Center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • David Yarnitsky, Professor

    Neurology Department Chairman, Rambam Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology department

Study Record Dates

First Submitted

March 19, 2006

First Posted

March 21, 2006

Study Start

December 1, 2005

Primary Completion

January 1, 2010

Study Completion

December 1, 2011

Last Updated

October 11, 2017

Record last verified: 2017-10

Locations