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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Analgesia; Opioid Use
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 636

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

Inclusion Criteria:

• elective, radical abdominal prostatectomy
• >18 years

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative opioid consumption	Consumption of piritramid [mg] in PACU.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-operative opioid consumption	Consumption of sufentanil [mg] during surgery. Piritramid is given if NRS score is > 3.	1 day
Pain maximum	Postoperative pain level measured with the highest score in numeric pain rating scale (NRS)	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.	1 day
PONV/Shivering	Occurence of post-operative nausea and vomiting or shivering in PACU.	1 day

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Investigators: Principal Investigator: Rainer Nitzschke, MD, Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): August 8, 2018
• Study Completion (Actual): October 14, 2018

Study Registration Dates

• First Submitted: April 24, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 25, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 042017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No