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NCT Number: NCT03565705

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

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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Key information

Conditions

Pain, Postoperative Agnosia Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Use Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

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

Hamburg, 20246, Germany

About this study

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.

...

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective, radical abdominal prostatectomy
  • >18 years

Exclusion criteria

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

Treatment and study plan

Open abdominal prostatectomy

Procedure

Patients undergo standardized open abdominal prostatectomy.

Primary outcomes

  1. Post-operative opioid consumption

    Time frame: 1 day

    Consumption of piritramid [mg] in PACU.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

Impact of Spinal Anesthesia on Peri-operative Opioid Consumption in Open Abdominal Prostatectomy- a Retrospective Analysis

Acronym: SAPOC

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2018
Registry last updated
Jan 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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