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CompletedNCT03565705SAPOCUpdated Jan 28, 2019

Spinal Anesthesia and Peri-operative Opioid Consumption in Open Abdominal Prostatectomy

An observational study in Pain, Postoperative, Opioid Use and Analgesia, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-28.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
636
Ages
18 Years and older
Sex
Male
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Study 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 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.

...

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Conditions studied

  • Pain, Postoperative
  • Opioid Use
  • Analgesia

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In context

Pain, Postoperative

5,089 studies on the registry are indexed under Pain, Postoperative; 1,137 are open to participants now.

This study's enrollment of 636 is above the median of 102 across 607 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • elective, radical abdominal prostatectomy
  • >18 years

Exclusion criteria

Exclusion Criteria:

  • chronic pain therapy (e.g. out-of-hospital opioid therapy)
  • laparoscopic approach
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
636 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Procedure: Open abdominal prostatectomy

Interventions

  • ProcedureOpen abdominal prostatectomy

    Patients undergo standardized open abdominal prostatectomy.

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What researchers measure

Primary outcomes

  1. Post-operative opioid consumption

    Consumption of piritramid \[mg\] in PACU.

    Time frame: 1 day

Secondary outcomes

  1. Intra-operative opioid consumption

    Consumption of sufentanil \[mg\] during surgery. Piritramid is given if NRS score is \> 3.

    Time frame: 1 day

  2. Pain maximum

    Postoperative pain level measured with the highest score in numeric pain rating scale (NRS)

    Time frame: 1 day

  3. Postoperative recovery time

    Time interval between postoperative tracheal extubation and the patient reaching fit-for-discharge criteria from the PACU to the ward.

    Time frame: 1 day

  4. PONV/Shivering

    Occurence of post-operative nausea and vomiting or shivering in PACU.

    Time frame: 1 day

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Study locations

1 site
  • Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
    Hamburg, 20246, Germany
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References and documents

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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03565705
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Sponsor
First posted
Jun 21, 2018
Start date
Apr 24, 2018
Primary completion
Aug 8, 2018
Completion
Oct 14, 2018
Last update
Jan 28, 2019

Study contacts

Rainer Nitzschke, MD
principal investigator · Universitätsklinikum Hamburg-Eppendorf

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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