Pain, Postoperative Clinical Trial
— SAPOCOfficial title:
Impact of Spinal Anesthesia on Peri-operative Opioid Consumption in Open Abdominal Prostatectomy- a Retrospective Analysis
NCT number | NCT03565705 |
Other study ID # | 042017 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 24, 2018 |
Est. completion date | October 14, 2018 |
Verified date | January 2019 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology; Center of Anesthesiology and Intensive Care Medicine, Hamburg Eppendorf University Medical Center | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
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 |
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