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NCT02305719 Clinical Trial

Regional Anesthesia for Thoracoscopic Surgery

Postoperative Pain Clinical Trial

— RATS  

Official title:
Regional Anesthesia for Thoracoscopic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02305719
Other study ID # LudwigMaximilians
Secondary ID
Status Recruiting
Phase N/A
First received November 28, 2014
Last updated December 2, 2014
Start date July 2014
Est. completion date June 2016

Study information
Verified date November 2014
Source Ludwig-Maximilians - University of Munich
Contact Philip M Lang, M.D., Ph.D.
Phone ++49-89-4400
Email philip.lang@med.uni-muenchen.de
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

A prospective evaluation of different regional anesthesia regimes for thoracoscopic surgery to elucidate their efficiency in (postoperative) pain control.

A day before surgery the patients gave their written informed consent to the study.

Patients choose their favorite regional anesthesia out of the following: thoracic epidural anesthesia, (ultrasound-guided) serratus-anterior-plane-block an local infiltration with local anesthetic at the site of performing the thoracoscopy.

In addition a general anesthesia was applied for the surgical procedure. Anesthesia was maintained using propofol and remifentanil. The patients pain score (visual analog scale), consumption of analgesic medication, satisfaction with pain therapy will be obtained one, six, 24 and 48 hours postoperatively.

These prospective evaluation of different regional anesthetic techniques might provide us data to recommend a procedure for thoracoscopic surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 2016
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients scheduled for thoracoscopic surgery

- ASA 1-3

Exclusion Criteria:

- ASA 4 and 5

- Age under 18 and over 80

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany University Hospital Munich, Marchioninistr. 15 Munich

Sponsors (1)
Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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