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OpenTrials
Completed

NCT Number: NCT05822882

Efficacy of Postoperative Epidural Anesthesia Following Abdominoplasty

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

ISAR Klinikum

München, Bavaria, 80331, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who underwent abdominoplasty

Exclusion criteria

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

Treatment and study plan

epidural anesthesia

Procedure

Postoperative pain management by epidural anesthesia via epidural catheter and pain pump

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Klinik Bogenhausen

Other

Collaborators

  • ISAR Klinikum

Registry information

Acronym: EDA

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 21, 2023
Registry last updated
Apr 21, 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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