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

Pain, Postoperative Clinical Trial

— SAPOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03565705
• Other study ID #: 042017
• Status: Completed
• Start date: April 24, 2018
• Est. completion date: October 14, 2018

Study information

• Verified date: January 2019
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 636
• Est. completion date: October 14, 2018
• Est. primary completion date: August 8, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• elective, radical abdominal prostatectomy

• >18 years

Exclusion Criteria:

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

• laparoscopic approach

Related Conditions & MeSH terms

• Analgesia
• Opioid Use
• Pain, Postoperative

Intervention

Procedure:
• Open abdominal prostatectomy
Patients undergo standardized open abdominal prostatectomy.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

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