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
Study ID
NCT07624006
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sublingual sufentanil 30 µg (one dose per hour, as needed) — DRUG
    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) — DRUG
    Opioid administration will be carried out from discharge from the post-anesthesia care unit until postoperative day 3 (D3) at 8:00 a.m.

Study Details

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 Dates

First listed
Jun 3, 2026
Start date
Jan 1, 2027
Status verified
May 2026
Primary completion
Feb 28, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
1,150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sublingual sufentani 30 µg
  • Active Comparator: Morphine sulfate

Primary Outcome Measure

Postoperative health recovery, evaluated by the score of the modified QoR-15F questionnaire administered at postoperative day 3 (D3). [ Time Frame: Day 3 ]

Central Contacts

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