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Evaluation of the Efficacy of Sublingual Sufentanil (Prescribed as Rescue Analgesia for Acute Postoperative Pain) on the Quality of Health Recovery After Surgery: a Randomized, Controlled, Multicenter, Open-label Trial Against an Active Comparator (SUBLIME)
Sponsor: University Hospital, Strasbourg, France
Summary
The number of surgical procedures performed annually exceeds 300 million worldwide and continues to grow. The management of the most common perioperative symptoms (pain, nausea/vomiting, constipation) represents a major public health challenge. In the context of postoperative pain management, a multimodal analgesia strategy is recommended in order to minimize opioid consumption. The opioid currently most commonly used is oral morphine sulfate. New therapeutic options are emerging, including sublingual sufentanil (Dzuveo®, 30 µg), which combines opioid-like effects with a faster onset of action due to its lipophilicity. The hypothesis of this study is that, because of its unique pharmacokinetic and pharmacodynamic profile, this new formulation is more effective than oral morphine sulfate in the treatment of postoperative pain and in the recovery of health status.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1150
Start Date
2027-01-01
Completion Date
2030-02-28
Last Updated
2026-06-03
Healthy Volunteers
No
Conditions
Interventions
Sublingual sufentanil 30 µg (one dose per hour, as needed)
Opioid administration will be carried out from discharge from the post-anesthesia care unit until postoperative day 3 (D3) at 8:00 a.m.
Morphine sulfate (10 mg every 4 hours as needed)
Opioid administration will be carried out from discharge from the post-anesthesia care unit until postoperative day 3 (D3) at 8:00 a.m.
Locations (1)
Hôpitaux Universitaires de Strasbourg
Strasbourg, France