Not Yet RecruitingPhase 4

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)

France1,150 participantsStarted 2027-01-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Aged 18 years or older (with no upper age limit) Undergoing surgery in a surgical department of the participating centers for a procedure whose usual postoperative management includes the prescription of an oral rescue opioid analgesic Able to provide informed consent Affiliated with a health insurance/social security system or beneficiary of such a system Exclusion Criteria: Known hypersensitivity to the components of Sublingual sufentanil 30 µg Known hypersensitivity to the components of Morphine sulfate Compromised respiratory function, such as decompensated respiratory failure or respiratory depression Severe hepatic insufficiency (i.e., with encephalopathy) Severe renal insufficiency (GFR \< 30) Acute head trauma with intracranial hypertension Uncontrolled epilepsy Ileus Patients receiving daily preoperative treatment with opioids such as morphine, sufentanil, fentanyl, oxycodone, buprenorphine, nalbuphine, methadone, naltrexone, nalmefene, or sodium oxybate Pregnant or breastfeeding women Incapacitated individuals (subject to legal protection measures: judicial protection, curatorship, guardianship, future protection mandate, or family authorization) Inability to administer the mQoR-15f questionnaire (cognitive impairment, language barrier) or inability to provide informed information to the subject (emergency situations, subject's comprehension difficulties, etc.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing sublingual sufentanil against another active pain medication for post-surgery recovery — can you tell me what the comparator drug is, and how the two approaches differ from what I would normally receive after my operation?
2Since this is a Phase 4 trial, the drug has already been approved, but is there anything specific about how sublingual sufentanil is being used here — as a rescue medication rather than routine pain control — that means there are still open questions about its benefits or risks in this setting?
3The study measures recovery quality using a questionnaire called the QoR-15F on day 3 after surgery — what does that kind of outcome actually mean for my day-to-day experience, and how does it compare to outcomes that matter most to me personally?
4This trial isn't recruiting yet — if I might be a candidate once it opens, what would participation actually require of me in those first three days after surgery, and would it change how my pain is managed in ways that could affect my recovery?
5Given that there are already approved options for managing post-surgery pain, is there a reason you'd recommend waiting to see if I qualify for this trial rather than starting with the standard pain management approach you'd normally use for my procedure?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 3

Trial details

NCT IDNCT07624006

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-02-28

Contact for this trial

Thomas PERRIN, MD

03 88 12 70 76 thomas.perrin@chru-strasbourg.fr

View on ClinicalTrials.gov More Postoperative Pain trials