NCT01009398

Brief Summary

Thoracic operations are known to be painful and requiring an adequate postoperative pain therapy. A well documented technique to achieve postoperative analgesia is the use of paravertebral catheters. Theoretically the thoracic paravertebral block results in an unilateral thoracic anaesthesia. However, in the daily clinical practice it remains unclear whether catheters are placed correctly into the paravertebral region. The investigators' experiences with paravertebral catheters suggest that there may be many displacements of catheters since the pain control is reduced compared to epidural analgesia. The aim of this prospective observational clinical trial is to postoperatively evaluate the exact location of paravertebral catheter placed for thoracoscopic interventions by using the classical land-mark puncture technique. After radiological detection of the catheter position, the spread and distribution of contrast dye injected through the catheters will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

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

November 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 3, 2011

Status Verified

February 1, 2011

Enrollment Period

1.1 years

First QC Date

November 5, 2009

Last Update Submit

February 2, 2011

Conditions

Thoracic Paravertebral Block

Keywords

Anesthesia and AnalgesiaRegional anesthesiaThoracic Paravertebral blockCatheter location

Outcome Measures

Primary Outcomes (1)

  • Exact position of the paravertebral catheter

    immediately

Secondary Outcomes (2)

  • Spread of contrast dye through the catheters

    immediately

  • Correlation of clinical effect of local anaesthetics injected through the catheters and documented spread of contrast dye

    immediately

Interventions

Fluoroscopic examinationOTHER

Localisation of the paravertebral catheter tip and documentation of the spread of contrast dye injected through the catheters by fluoroscopic examination

Eligibility Criteria

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

All patients who are scheduled for a thoracoscopic intervention with planned placement of paravertebral catheters as their standard postoperative pain treatment strategy are eligible for this prospective observational clinical trial.

You may qualify if:

  • Patient scheduled for thoracoscopic intervention
  • Planned placement of paravertebral catheters

You may not qualify if:

  • Refusal to participate
  • Age \< 18
  • Severe hepatic disfunction (Liver disease Child B or C)
  • known allergies to iodinated contrast material
  • Morbus Waldenström
  • multiple myeloma
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital and University of Bern, Department of Anaesthesiology and Pain Therapy

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (3)

  • Eason MJ, Wyatt R. Paravertebral thoracic block-a reappraisal. Anaesthesia. 1979 Jul-Aug;34(7):638-42. doi: 10.1111/j.1365-2044.1979.tb06363.x.

    PMID: 517716BACKGROUND

  • Hill SE, Keller RA, Stafford-Smith M, Grichnik K, White WD, D'Amico TA, Newman MF. Efficacy of single-dose, multilevel paravertebral nerve blockade for analgesia after thoracoscopic procedures. Anesthesiology. 2006 May;104(5):1047-53. doi: 10.1097/00000542-200605000-00022.

    PMID: 16645458BACKGROUND

  • Luyet C, Eichenberger U, Greif R, Vogt A, Szucs Farkas Z, Moriggl B. Ultrasound-guided paravertebral puncture and placement of catheters in human cadavers: an imaging study. Br J Anaesth. 2009 Apr;102(4):534-9. doi: 10.1093/bja/aep015. Epub 2009 Feb 24.

    PMID: 19244265BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Urs Eichenberger, M.D.

    University Hospital and University of Bern, Department of Anaesthesiology and Pain therapy

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

November 1, 2009

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

February 3, 2011

Record last verified: 2011-02

Locations

CH(1)