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

Completed

• Conditions: Neuropathic Pain; Thoracic Cancer; Chronic Pain

• Registration Number: NCT05909007
• Lead Sponsor: AHEPA University Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1145

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of major complications	3 YEARS

Trial Locations

Locations (1)

Ahepa University Hospital; 🇬🇷 Thessaloniki, Greece