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NCT05909007 Clinical Trial

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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05909007
Other study ID # 1111
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 2012
Est. completion date November 2014

Study information
Verified date June 2023
Source AHEPA University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 1145
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• thoracic epidural insertion
thoracic epidural for pain relief after major thoracic surgery and lung transplantation

Locations
Country Name City State
Greece Ahepa University Hospital Thessaloniki

Sponsors (2)
Lead Sponsor Collaborator
AHEPA University Hospital Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of major complications 3 YEARS
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