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Completed

NCT Number: NCT05909007

Post-operative Thoracic Epidural Analgesia and Incidence of Major Complications: a Large Retrospective Dual Center Experi-ence

A retrospective observational dual center study investigating side effects and major complications after thoracic epidural insertion according to local safety protocols.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahepa University Hospital

Thessaloniki, 54636, Greece

About this study

Abstract: (1) Background: Thoracic epidural analgesia is considered the gold standard in post-operative pain management following thoracic surgery. This study was designed to explore the safety of thoracic epidural analgesia and to quantify the incidence of its post-operative side-effects in patients undergoing thoracotomy for major surgery, such as resection of lung malignancies and lung transplantation. (2) Methods: This is a retrospective, dual-center observa-tional study implementing patients that underwent major thoracic surgery including lung trans-plantation and received concurrent placement of thoracic epidural catheters for postoperative an-algesia. An electronic system of referral and documentation of complications was used, and information was retrieved from our electronic critical care charting system. Side effects such as nausea and vomiting , itching, catheter related issues and also major complications such as epidural haematoma, abscess, or permanent nerve damage were investigated.

The study aims to highlight the importance of a solid documentation and recording system alongside with the implementation of safety protocols.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. All patients undergoing major thoracic surgery ASA1-3 2. All patients undergoing lung transplantation

Exclusion criteria

1. Active bleeding 2. Coagulopathy 3. High inflammatory markers 4. SIRS 5. Lack of patients' consent for throracic epidural insertion

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Treatment and study plan

thoracic epidural insertion

Procedure

thoracic epidural for pain relief after major thoracic surgery and lung transplantation

Primary outcomes

  1. incidence of major complications

    Time frame: 3 YEARS

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Collaborators

  • Royal Brompton & Harefield NHS Foundation Trust

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 18, 2023
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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