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Clinical Trials/NCT05208619
NCT05208619
Recruiting
Not Applicable

Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery

University Hospital, Bonn2 sites in 1 country118 target enrollmentAugust 9, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thoracic Surgery
Sponsor
University Hospital, Bonn
Enrollment
118
Locations
2
Primary Endpoint
Opiate consumption
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery

Detailed Description

Thoracic interventions (lung operations) are associated with considerable postoperative pain, whereby an open surgical procedure via a skin incision (thoracotomy) is more painful than a minimally invasive endoscopic intervention (thoracoscopy). In order to reduce pain, a regional anaesthetic is administered during the induction of anaesthesia, which reduces pain both intraoperatively and postoperatively. In thoracic surgery, thoracic epidural analgesia (PDA) and paravertebral block (PVB) are the main regional anaesthesiological measures used, although it is unclear which of the two procedures is superior in terms of efficiency and effectiveness. Particularly intraoperatively, but also to some extent postoperatively, regional anaesthesia alone is usually not sufficient for pain management. Rather, additional systemic (i.e. intravenous) analgesics (especially opioids) are administered. Therefore, the amount of these additionally administered analgesics is a measure of the efficiency of the regional anaesthesia procedure.

Registry
clinicaltrials.gov
Start Date
August 9, 2022
End Date
April 30, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bonn
Responsible Party
Principal Investigator
Principal Investigator

Martin Soehle

Vice Head of Department

University Hospital, Bonn

Eligibility Criteria

Inclusion Criteria

  • elective thoracic surgery
  • American Society of Anaesthesiologists (ASA) 1-3 status
  • written informed consent

Exclusion Criteria

  • pregnancy
  • adipositas (bmi \> 30)
  • cardiac arrhythmia
  • coagulation abnormalities
  • chronic pain
  • opiate abuses

Outcomes

Primary Outcomes

Opiate consumption

Time Frame: intraoperative

intraoperative opiate consumption

Secondary Outcomes

  • postoperative pain(up to day 2 after surgery)
  • anaesthetic depth(intraoperative)
  • intraoperative nociception(intraoperative)
  • Patient recovery(at day 1 after surgery)
  • Patient satisfaction(at day 2 after surgery)
  • pain score(from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission))

Study Sites (2)

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