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

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ClinicalTrials.gov Identifier: NCT03565705
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Pain, Postoperative Opioid Use Analgesia Procedure: Open abdominal prostatectomy

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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Study Design
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Study Type : Observational
Actual Enrollment : 636 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Impact of Spinal Anesthesia on Peri-operative Opioid Consumption in Open Abdominal Prostatectomy- a Retrospective Analysis
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : October 14, 2018
Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Patients undergo standardized 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
Patients undergo standardized open abdominal prostatectomy.


Outcome Measures
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Primary Outcome Measures :
  1. Post-operative opioid consumption [ Time Frame: 1 day ]
    Consumption of piritramid [mg] in PACU.


Secondary Outcome Measures :
  1. Intra-operative opioid consumption [ Time Frame: 1 day ]
    Consumption of sufentanil [mg] during surgery. Piritramid is given if NRS score is > 3.

  2. Pain maximum [ Time Frame: 1 day ]
    Postoperative pain level measured with the highest score in numeric pain rating scale (NRS)

  3. Postoperative recovery time [ Time Frame: 1 day ]
    Time interval between postoperative tracheal extubation and the patient reaching fit-for-discharge criteria from the PACU to the ward.

  4. PONV/Shivering [ Time Frame: 1 day ]
    Occurence of post-operative nausea and vomiting or shivering in PACU.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • elective, radical abdominal prostatectomy
  • >18 years

Exclusion Criteria:

  • chronic pain therapy (e.g. out-of-hospital opioid therapy)
  • laparoscopic approach
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565705


Locations
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Germany
Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Principal Investigator: Rainer Nitzschke, MD Universitätsklinikum Hamburg-Eppendorf
More Information
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT03565705    
Other Study ID Numbers: 042017
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations