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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05822882
Other study ID # EDA following Abdominoplasty
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 14, 2022
Est. completion date February 24, 2023

Study information

Verified date April 2023
Source Klinik Bogenhausen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date February 24, 2023
Est. primary completion date February 24, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Epidural anesthesia
Postoperative pain management by epidural anesthesia via epidural catheter and pain pump

Locations

Country Name City State
Germany ISAR Klinikum München Bayern

Sponsors (2)

Lead Sponsor Collaborator
Klinik Bogenhausen ISAR Klinikum

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary frequency of retrieval of the on-demand non-epidural opiate 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 postoperative mobilization ability 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
Secondary timing of urinary catheter removal 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
Secondary length of hospital stay 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
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