Regional Anesthesia for Thoracoscopic Surgery (RATS)

December 2, 2014 updated by: Philip Lang, Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients scheduled for thoracoscopic surgery ASA 1-3

Description

Inclusion Criteria:

  • Patients scheduled for thoracoscopic surgery
  • ASA 1-3

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain (visual analog scale)
Time Frame: 48 hours postoperative
the postoperative Pain, evaluated with a visual analog scale (VAS), was obtained in the first 48 hours postoperatively after thoracoscopic surgery
48 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Investigators

  • Principal Investigator: Philip M Lang, M.D., Ph. D., Attending

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

November 28, 2014

First Submitted That Met QC Criteria

December 2, 2014

First Posted (Estimate)

December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LudwigMaximilians

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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