NCT05208619

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

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
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

December 9, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 26, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

August 9, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

2.4 years

First QC Date

December 9, 2021

Last Update Submit

November 21, 2023

Conditions

Thoracic Surgery

Keywords

Thoracic surgeryparavertebral blockepidural analgesiaThoracic anaesthesia

Outcome Measures

Primary Outcomes (1)

  • Opiate consumption

    intraoperative opiate consumption

    intraoperative

Secondary Outcomes (6)

  • pain score

    from admission to post-anaesthesia care unit (PACU) until discharge from PACU (up to 1 hour after admission)

  • postoperative pain

    up to day 2 after surgery

  • anaesthetic depth

    intraoperative

  • intraoperative nociception

    intraoperative

  • Patient recovery

    at day 1 after surgery

  • +1 more secondary outcomes

Study Arms (2)

thoracic epidural analgesia

ACTIVE COMPARATOR

A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter.

Procedure: Regional anaesthesia

paravertebral block

ACTIVE COMPARATOR

A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia.

Procedure: Regional anaesthesia

Interventions

Regional anaesthesiaPROCEDURE

Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery

paravertebral blockthoracic epidural analgesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Bonn, 53127, Germany

RECRUITING

Helios Klinikum Bonn/Rhein-Sieg

Bonn, 53127, Germany

RECRUITING

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Central Study Contacts

Martin Soehle, MD, PhD, MHBA

CONTACT

++49-228-287-14127martin.soehle@ukbonn.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Head of Department

Study Record Dates

First Submitted

December 9, 2021

First Posted

January 26, 2022

Study Start

August 9, 2022

Primary Completion

January 15, 2025

Study Completion

April 30, 2025

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)