NCT01300195

Brief Summary

Prospective cohort study of factors predisposing to persistent post surgical pain after video-assisted thoracic surgery

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 21, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

Enrollment Period

1.8 years

First QC Date

February 18, 2011

Last Update Submit

September 27, 2011

Conditions

Pain, Postoperative

Keywords

VATSstandardized surgerypersistent pain

Outcome Measures

Primary Outcomes (2)

  • Persistent post surgical pain

    Pain intensity (Numerical Rating Scale)

    3 months

  • Analgesic use

    type(s) and amount of analgesics used

    3 months

Study Arms (1)

lung cancer surgery

Patients undergoing video-assisted thoracic surgery

Eligibility Criteria

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

Lung cancer patients

You may qualify if:

  • Age \< 18 years old
  • Elective lung cancer surgery (VATS)

You may not qualify if:

  • do not understand Danish
  • cognitive reduction
  • bilateral procedure planned
  • previous thoracic surgery
  • pregnant or nursing
  • known nerve affection from other cause
  • alcohol/substance abuse
  • inability to cooperate to pain scoring/sensory examination
  • \> 5 mg methylprednisolone/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section for Surgical Pathophysiology 4074

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

  • Werner MU, Ringsted TK, Kehlet H, Wildgaard K. Sensory testing in patients with postthoracotomy pain syndrome: Part 1: mirror-image sensory dysfunction. Clin J Pain. 2013 Sep;29(9):775-83. doi: 10.1097/AJP.0b013e318277b646.

    PMID: 23328340DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood used to detect genetic polymorphism

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Kim Wildgaard, MD

CONTACT

+45 3545 3246wildgaard@thoracotomy.eu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2011

First Posted

February 21, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2012

Study Completion

April 1, 2013

Last Updated

September 28, 2011

Record last verified: 2011-09

Locations

DK(1)