AnesthesiaEDANCT05822882
Efficacy of Postoperative Epidural Anesthesia Following Abdominoplasty
An observational study of Anesthesia and Abdominoplasty, run by Klinik Bogenhausen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia, Abdominoplasty
- What is being tested?
- Epidural anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 112 participants
- Where
- 1 siteGermany
- Study dates
- 14 Dec 2022to 24 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent abdominoplasty at the Department of Plastic Surgery, ISAR Klinikum, Munich, Germany, between September 2018 and August 2022
Who may be able to join
- Patients who underwent abdominoplasty
Who cannot join
- Patients who underwent abdominoplasty combined with additional intraoperative procedures (e.g., liposuction, hernia repair) were excluded
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anesthesia, Abdominoplasty
- Being tested
- Epidural anesthesia
- Keywords
- abdominoplasty, postoperative analgesia, regional anesthesia, epidural anesthesia, epidural catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
Postoperative pain management by epidural anesthesia via epidural catheter and pain pump
| Study group | Role | What they receive |
|---|---|---|
| Patients with epidural anesthesia | Patients following Abdominoplasty with postoperative epidural anesthesia via pain catheter Receives: Procedure: Epidural anesthesia | |
| Patients without epidural anesthesia | Patients following Abdominoplasty without postoperative epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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)
Measured: 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
timing of urinary catheter removal after surgery
Measured: 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
number of days from the day of surgery until dischargement
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start14 Dec 2022
- Primary completion24 Feb 2023
- Study completion24 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Bogenhausen
- Sponsor type
- University, hospital or other
- Collaborators
- ISAR Klinikum
- Responsible party
- Principal investigator, Ulf Dornseifer, MD, ISAR Klinikum
- Investigators
- Ulf Dornseifer, MD, Principal investigator, ISAR Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822882
- Sponsor's protocol ID
- EDA following Abdominoplasty
- Acronym
- EDA
- Status last verified
- Apr 2023
- First submitted
- 11 Mar 2023
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Postoperative Epidural Anesthesia Following Abdominoplasty
- ClinicalTrials.gov ID
- NCT05822882
- Acronym / sponsor ID
- EDA / EDA following Abdominoplasty
- Conditions
- Anesthesia, Abdominoplasty
- Keywords
- abdominoplasty, postoperative analgesia, regional anesthesia, epidural anesthesia, epidural catheter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Klinik BogenhausenUniversity, hospital or other
- Collaborators
- ISAR Klinikum
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 24 Feb 2023 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with epidural anesthesia | – | Procedure: Epidural anesthesiaPatients following Abdominoplasty with postoperative epidural anesthesia via pain catheter |
| Patients without epidural anesthesia | – | –Patients following Abdominoplasty without postoperative epidural anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent abdominoplasty at the Department of Plastic Surgery, ISAR Klinikum, Munich, Germany, between September 2018 and August 2022
Key inclusion criteria (1 listed)
- Patients who underwent abdominoplasty
Key exclusion criteria (1 listed)
- Patients who underwent abdominoplasty combined with additional intraoperative procedures (e.g., liposuction, hernia repair) were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaPostoperative pain management by epidural anesthesia via epidural catheter and pain pump | Procedure or surgery | Patients with epidural anesthesia |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Dornseifer, MD principal investigator
ISAR Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia and Abdominoplasty, run by Klinik Bogenhausen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.