Status:
COMPLETED
Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Postoperative Pain
Spinal Fusion
Eligibility:
All Genders
18-75 years
Brief Summary
The Zalviso® Sufentanil Sublingual Tablet System (SSTS) (Grünenthal Italia, Milan, Italy) is a patient-controlled analgesia (PCA) system approved in September 2015 by the European Commission for the m...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients who underwent elective open lumbar arthrodesis surgery (either by an anterior or posterior approach) in degenerative lumbar spine conditions who were between 18 and 75 years old and post-operatively treated with Sufentanil NanoTab PCA system as part of a multimodal analgesic regimen.
- General anesthesia was performed. Perioperative regional anesthetic techniques and local anesthetic wound infiltration in the operating room were not performed.
- Exclusion criteria:
- Patients who refused to participate in the study.
Exclusion
Key Trial Info
Start Date :
September 19 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 10 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03459404
Start Date
September 19 2018
End Date
March 10 2019
Last Update
August 23 2021
Active Locations (1)
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1
Policlinico A. Gemelli
Rome, Italy, 00168