Pain, PostoperativeSAPOCNCT03565705
Spinal Anesthesia and Peri-operative Opioid Consumption in Open Abdominal Prostatectomy
An observational study of Pain, Postoperative and Opioid Use, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain, Postoperative, Opioid Use, Analgesia
- What is being tested?
- Open abdominal prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 636 participants
- Where
- 1 siteGermany
- Study dates
- 24 Apr 2018to 14 Oct 2018
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: We aim to include patients that are scheduled for elective, radical open abdominal prostatectomy. Thus only male patients of 18 years or older will participate. Patients with chronic pain therapy (e.g. out-of-hospital opioid therapy) will be excluded from the study.
Who may be able to join
- elective, radical abdominal prostatectomy
- >18 years
Who cannot join
- chronic pain therapy (e.g. out-of-hospital opioid therapy)
- laparoscopic approach
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Hamburg, 20246
About this study
Official title: Impact of Spinal Anesthesia on Peri-operative Opioid Consumption in Open Abdominal Prostatectomy- a Retrospective Analysis
Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.
Read the detailed description
Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.
...
- Conditions
- Pain, Postoperative, Opioid Use, Analgesia
- Being tested
- Open abdominal prostatectomy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open abdominal prostatectomyProcedure or surgery
Patients undergo standardized open abdominal prostatectomy.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia with propofol sedation | Patients receive spinal anesthesia for analgesia to undergo open abdominal prostatectomy. Ventilation is secured via a laryngeal mask under propofol sedation and no muscular blocking is necessary. Receives: Procedure: Open abdominal prostatectomy | |
| General anesthesia | General anesthesia is conducted with a combination of intravenous opioid (sufentanil) and neuromuscular blocking agent for open abdominal prostatectomy. Patients receive an induction bolus of propofol, undergo tracheal intubation and maintenance of sedation by sevoflurane. Receives: Procedure: Open abdominal prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative opioid consumption
Consumption of piritramid [mg] in PACU.
Measured: 1 day
Secondary outcomes (4)
Intra-operative opioid consumption
Consumption of sufentanil [mg] during surgery. Piritramid is given if NRS score is > 3.
Measured: 1 day
Pain maximum
Postoperative pain level measured with the highest score in numeric pain rating scale (NRS)
Measured: 1 day
Postoperative recovery time
Time interval between postoperative tracheal extubation and the patient reaching fit-for-discharge criteria from the PACU to the ward.
Measured: 1 day
PONV/Shivering
Occurence of post-operative nausea and vomiting or shivering in PACU.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start24 Apr 2018
- Primary completion8 Aug 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rainer Nitzschke, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565705
- Sponsor's protocol ID
- 042017
- Acronym
- SAPOC
- Status last verified
- Jan 2019
- First submitted
- 24 Apr 2018
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Funcke S, Schick-Bengardt X, Pinnschmidt HO, Beyer B, Fischer M, Kahl U, Nitzschke R. The impact of spinal anaesthesia on perioperative opioid consumption, postoperative pain and oncological outcome in radical retropubic prostatectomy-a retrospective before-and-after effectiveness study. Perioper Med (Lond). 2022 Oct 3;11(1):49. doi: 10.1186/s13741-022-00281-0.
PubMed 36184629
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Spinal Anesthesia on Peri-operative Opioid Consumption in Open Abdominal Prostatectomy- a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03565705
- Acronym / sponsor ID
- SAPOC / 042017
- Conditions
- Pain, Postoperative, Opioid Use, Analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 21 Jun 2018 (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.
Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.
Detailed description
Retrospective analysis to assess the impact of spinal anesthesia on peri-operative opioid consumption during open abdominal prostatectomy. The authors compare the group that had spinal anesthesia in combination with propofol sedation and a laryngeal mask to the second group that underwent the same procedure in general anesthesia with tracheal intubation.
...
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia with propofol sedation | – | Procedure: Open abdominal prostatectomyPatients receive spinal anesthesia for analgesia to undergo open abdominal prostatectomy. Ventilation is secured via a laryngeal mask under propofol sedation and no muscular blocking is necessary. |
| General anesthesia | – | Procedure: Open abdominal prostatectomyGeneral anesthesia is conducted with a combination of intravenous opioid (sufentanil) and neuromuscular blocking agent for open abdominal prostatectomy. Patients receive an induction bolus of propofol, undergo tracheal intubation and maintenance of sedation by sevoflurane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We aim to include patients that are scheduled for elective, radical open abdominal prostatectomy. Thus only male patients of 18 years or older will participate. Patients with chronic pain therapy (e.g. out-of-hospital opioid therapy) will be excluded from the study.
Key inclusion criteria (2 listed)
- elective, radical abdominal prostatectomy
- >18 years
Key exclusion criteria (2 listed)
- chronic pain therapy (e.g. out-of-hospital opioid therapy)
- laparoscopic approach
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 |
|---|---|---|
| Open abdominal prostatectomyPatients undergo standardized open abdominal prostatectomy. | Procedure or surgery | General anesthesia, Spinal anesthesia with propofol sedation |
Primary outcome
Post-operative opioid consumption
Time frame: 1 day
Consumption of piritramid [mg] in PACU.
4 secondary outcomes
Intra-operative opioid consumption
Time frame: 1 day
Pain maximum
Time frame: 1 day
Postoperative recovery time
Time frame: 1 day
PONV/Shivering
Time frame: 1 day
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 28 Jan 2019.
- Derived from this study: PubMed 36184629Funcke S, Schick-Bengardt X, Pinnschmidt HO, Beyer B, Fischer M, Kahl U, Nitzschke R. The impact of spinal anaesthesia on perioperative opioid consumption, postoperative pain and oncological outcome in radical retropubic prostatectomy-a retrospective before-and-after effectiveness study. Perioper Med (Lond). 2022 Oct 3;11(1):49. doi: 10.1186/s13741-022-00281-0.
- Individual participant dataSharing planned: No
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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.
Rainer Nitzschke, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
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 Pain, Postoperative and Opioid Use, run by Universitätsklinikum Hamburg-Eppendorf 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 2 inclusion and 2 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 28 Jan 2019. 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?
Post-operative opioid consumption (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03565705, which also lists 1 linked publication.
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 28 Jan 2019.