Efficacy of Postoperative Epidural Anesthesia Following Abdominoplasty

NCT05822882 | Completed

• 1 other identifier: EDA following Abdominoplasty
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Abdominoplasty

Keywords

abdominoplasty; postoperative analgesia; regional anesthesia; epidural anesthesia; epidural catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Patients with epidural anesthesia

Patients following Abdominoplasty with postoperative epidural anesthesia via pain catheter

Procedure: Epidural anesthesia

Patients without epidural anesthesia

Patients following Abdominoplasty without postoperative epidural anesthesia

Interventions

Epidural anesthesia PROCEDURE

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

Patients with epidural anesthesia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients who underwent abdominoplasty

You may not qualify if:

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

Sponsors & Collaborators

• Klinik Bogenhausen: lead
• ISAR Klinikum: collaborator

Study Sites (1)

ISAR Klinikum

München, Bavaria, 80331, Germany

Location

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Ulf Dornseifer, MD

  ISAR Klinikum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: April 21, 2023
• Study Start: December 14, 2022
• Primary Completion: February 24, 2023
• Study Completion: February 24, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Locations

DE (1)