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

NCT03565705 | Completed

• 1 other identifier: 042017
• Study Type: observational
• Target: 636
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Opioid Use; Analgesia

Outcome Measures

Primary Outcomes (1)

• Post-operative opioid consumption

  Consumption of piritramid \[mg\] in PACU.

  1 day

Secondary Outcomes (4)

• Intra-operative opioid consumption

  1 day

• Pain maximum

  1 day

• Postoperative recovery time

  1 day

• PONV/Shivering

  1 day

Study Arms (2)

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

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

Interventions

Open abdominal prostatectomy PROCEDURE

Patients undergo standardized open abdominal prostatectomy.

General anesthesia; Spinal anesthesia with propofol sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• elective, radical abdominal prostatectomy
• \>18 years

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

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

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 36184629 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Rainer Nitzschke, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 21, 2018
• Study Start: April 24, 2018
• Primary Completion: August 8, 2018
• Study Completion: October 14, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)