Clinical Trial

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)

Study acronym: SUBLIME
Not Yet Recruiting Phase 4
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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.
Trial Details
NCT Number NCT07624006
Lead Sponsor University Hospital, Strasbourg, France
Conditions Postoperative Pain
Enrollment 1,150 participants
Start Date 2027-01-01
Primary Completion 2030-02-28 (estimated)
Study Completion 2030-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-03