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

NCT ID: NCT03565705

Last Updated: 2019-01-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 636 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-24
• Study Completion Date: 2018-10-14

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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Conditions

Pain, Postoperative; Opioid Use; Analgesia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Open abdominal prostatectomy

Intervention Type: PROCEDURE

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.

Open abdominal prostatectomy

Intervention Type: PROCEDURE

Patients undergo standardized open abdominal prostatectomy.

Interventions

Open abdominal prostatectomy

Patients undergo standardized open abdominal prostatectomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• elective, radical abdominal prostatectomy
• >18 years

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rainer Nitzschke, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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

Hamburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 36184629 (View on PubMed)

Other Identifiers

042017

Identifier Type: -

Identifier Source: org_study_id