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

Completed

• Conditions: Pain, Postoperative; Opioid Use; Analgesia
• Interventions: Procedure: Open abdominal prostatectomy

• Registration Number: NCT03565705
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

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 Timeline

• Study Start: 2018-04-24
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-21
• Primary Completion: 2018-08-08
• Study Completion: 2018-10-14
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 636

Inclusion Criteria

• elective, radical abdominal prostatectomy
• >18 years

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
General anesthesia	Open abdominal prostatectomy	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.
Spinal anesthesia with propofol sedation	Open abdominal prostatectomy	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.

Primary Outcome Measures

Name	Time	Method
Post-operative opioid consumption	1 day	Consumption of piritramid \[mg\] in PACU.

Secondary Outcome Measures

Name	Time	Method
PONV/Shivering	1 day	Occurence of post-operative nausea and vomiting or shivering in PACU.
Pain maximum	1 day	Postoperative pain level measured with the highest score in numeric pain rating scale (NRS)
Postoperative recovery time	1 day	Time interval between postoperative tracheal extubation and the patient reaching fit-for-discharge criteria from the PACU to the ward.
Intra-operative opioid consumption	1 day	Consumption of sufentanil \[mg\] during surgery. Piritramid is given if NRS score is \> 3.

Trial Locations

Locations (1)

Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center; 🇩🇪 Hamburg, Germany