Efficacy of Postoperative Epidural Anesthesia Following Abdominoplasty (EDA)

April 9, 2023 updated by: Ulf Dornseifer, MD, Klinik Bogenhausen
Effective postoperative pain management is essential for patient satisfaction and therefore intraoperative regional nerve blocks have become more and more popular in abdominoplasties. However, the key disadvantage of these blocks are their limited duration of action. This observational study evaluates the effects of a longer- lasting, individualized epidural analgesia using a pain pump to better classify the clinical value of this procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This work reviews the digital medical charts of patients who underwent selective abdominoplasty without additive surgical procedures within a period of 4 years. Evaluated data comprise the postoperative analgesia regimen, including on-demand medication, mobilization time, inpatient length of stay, and clinical outcome. The patients were grouped by the presence of an epidural catheter.

Study Type

Observational

Enrollment (Actual)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • München, Bayern, Germany, 80331
        • ISAR Klinikum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients who underwent abdominoplasty at the Department of Plastic Surgery, ISAR Klinikum, Munich, Germany, between September 2018 and August 2022

Description

Inclusion Criteria:

• Patients who underwent abdominoplasty

Exclusion Criteria:

• Patients who underwent abdominoplasty combined with additional intraoperative procedures (e.g., liposuction, hernia repair) were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with epidural anesthesia
Patients following Abdominoplasty with postoperative epidural anesthesia via pain catheter
Procedure: Epidural anesthesia
Postoperative pain management by epidural anesthesia via epidural catheter and pain pump
Patients without epidural anesthesia
Patients following Abdominoplasty without postoperative epidural anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
frequency of retrieval of the on-demand non-epidural opiate
Time Frame: from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days
frequency of retrieval of the on-demand non-epidural opiate as a measure of perceived pain discomfort
from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative mobilization ability
Time Frame: from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days
the time at which the patient was able to move at room level with the assistance of a nurse (assisted full mobilization), the time at which the patient was able to get out of bed independently and move without assistance (independent full mobilization)
from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days
timing of urinary catheter removal
Time Frame: from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days
timing of urinary catheter removal after surgery
from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days
length of hospital stay
Time Frame: from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days
number of days from the day of surgery until dischargement
from the day of inpatient admission to the day of discharge of every included patient. The event determined by reviewing digital medical charts, is therefore assessed for an estimated period of up to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinik Bogenhausen

Collaborators

ISAR Klinikum

Investigators

  • Principal Investigator: Ulf Dornseifer, MD, ISAR Klinikum

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Actual)

February 24, 2023

Study Completion (Actual)

February 24, 2023

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

April 9, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 9, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDA following Abdominoplasty

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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