EDA: Efficacy of Postoperative Epidural Anesthesia Following Abdominoplasty

Sponsor
Klinik Bogenhausen (Other)
Overall Status
Completed
CT.gov ID
NCT05822882
Collaborator
ISAR Klinikum (Other)
112
1
2.4
47.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Epidural anesthesia

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 Design

Study Type:
Observational
Actual Enrollment :
112 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Efficacy of Postoperative Epidural Anesthesia Following Abdominoplasty
Actual Study Start Date :
Dec 14, 2022
Actual Primary Completion Date :
Feb 24, 2023
Actual Study Completion Date :
Feb 24, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. frequency of retrieval of the on-demand non-epidural opiate [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 Outcome Measures

  1. postoperative mobilization ability [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

• Patients who underwent abdominoplasty

Exclusion Criteria:

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ISAR Klinikum München Bayern Germany 80331

Sponsors and Collaborators

  • Klinik Bogenhausen
  • ISAR Klinikum

Investigators

  • Principal Investigator: Ulf Dornseifer, MD, ISAR Klinikum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ulf Dornseifer, MD, Principal Investigator, ISAR Klinikum
ClinicalTrials.gov Identifier:
NCT05822882
Other Study ID Numbers:
  • EDA following Abdominoplasty
First Posted:
Apr 21, 2023
Last Update Posted:
Apr 21, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ulf Dornseifer, MD, Principal Investigator, ISAR Klinikum
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 21, 2023