NCT02305719

Brief Summary

Aim of the study is to evaluate different regional anesthesia regimes for thoracoscopic surgery to evaluate their efficiency in (postoperative) pain control. Three regional anesthesia forms are evaluated: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.

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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

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

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 3, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 3, 2014

Status Verified

November 1, 2014

Enrollment Period

11 months

First QC Date

November 28, 2014

Last Update Submit

December 2, 2014

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain (visual analog scale)

    the postoperative Pain, evaluated with a visual analog scale (VAS), was obtained in the first 48 hours postoperatively after thoracoscopic surgery

    48 hours postoperative

Study Arms (3)

Epidural anesthesia

Patients receiving thoracic epidural anesthesia for thoracoscopic surgery. Standard regimen with 8-20 ml Ropivacaine 0,5% in the epidural catheter. Postopertive Ropivacaine 0,2% 6 ml/h via catheter were administered.

Serratus-anterior-plane-Block

Patients receiving (ultrasound-guided) Serratus-anterior-plane-Block for thoracoscopic surgery. Standard regimen up to 20 ml Ropivacaine 0,5%, were installed. Postopertive Ropivacaine 0,2% 6 ml/h via catheter were administered.

Local infiltration

Patients receiving local infiltration with up to 20 ml Ropivacaine 0,5% for thoracoscopic surgery (at the site of thoracoscopy)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for thoracoscopic surgery ASA 1-3

You may qualify if:

  • Patients scheduled for thoracoscopic surgery
  • ASA 1-3

You may not qualify if:

  • ASA 4 and 5
  • Age under 18 and over 80

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Munich, Marchioninistr. 15

Munich, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Philip M Lang, M.D., Ph. D.

    Attending

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip M Lang, M.D., Ph.D.

CONTACT

++49-89-4400philip.lang@med.uni-muenchen.de

Philipp Hering, M.D.

CONTACT

++49-89-4400philipp.hering@med.uni-muenchen.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 28, 2014

First Posted

December 3, 2014

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2016

Last Updated

December 3, 2014

Record last verified: 2014-11

Locations

DE(1)