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

• Sponsor: AHEPA University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05909007
• Collaborator: Royal Brompton & Harefield NHS Foundation Trust (Other)
• Enrollment: 1,145
• Location: 1
• Actual Duration (Months): 31
• Patients Per Site Per Month: 36.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Neuropathic Pain; Chronic Pain; Thoracic Cancer	Procedure: thoracic epidural insertion

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 Design

• Study Type: Observational
• Actual Enrollment: 1145 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Post-operative Thoracic Epidural Analgesia and Incidence of Major Complications: a Large Retrospective Dual Center Experi-ence
• Actual Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Outcome Measures

Primary Outcome Measures

1. incidence of major complications [3 YEARS]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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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Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahepa University Hospital	Thessaloniki		Greece	54636

Sponsors and Collaborators

• AHEPA University Hospital
• Royal Brompton & Harefield NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DESPOINA SARRIDOU, Assistant Professor of Anaesthesia, AHEPA University Hospital
• ClinicalTrials.gov Identifier: NCT05909007
• Other Study ID Numbers: 1111
• First Posted: Jun 18, 2023
• Last Update Posted: Jun 18, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neuralgia; Chronic Pain

Study Results

No Results Posted as of Jun 18, 2023