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

Completed

• Conditions: Pain, Postoperative; Opioid Use; Analgesia

• 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.
PONV/Shivering	1 day	Occurence of post-operative nausea and vomiting or shivering in PACU.

Trial Locations

Locations (1)

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