Postoperative PainPhase 4SUBLIMENCT07624006
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)
A Phase 4 study testing Sublingual sufentanil 30 µg (one dose per hour, as needed) and Morphine sulfate (10 mg every 4 hours as needed) in people with Postoperative Pain, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Sublingual sufentanil 30 µg (one dose per hour, as needed) and Morphine sulfate (10 mg every 4 hours as needed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2027to 28 Feb 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Thomas PERRIN, MD, 03 88 12 70 76 ext. 0033, thomas.perrin@chru-strasbourg.fr
About this study
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.
- Conditions
- Postoperative Pain
- Being tested
- Sublingual sufentanil 30 µg (one dose per hour, as needed), Morphine sulfate (10 mg every 4 hours as needed)
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Sublingual sufentani 30 µg | Experimental | Not described Receives: Drug: Sublingual sufentanil 30 µg (one dose per hour, as needed) |
| Morphine sulfate | Active comparator | Not described Receives: Drug: Morphine sulfate (10 mg every 4 hours as needed) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative health recovery, evaluated by the score of the modified QoR-15F questionnaire administered at postoperative day 3 (D3).
QoR-15F questionnaire score
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas PERRIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07624006
- Sponsor's protocol ID
- RC26_0234
- Acronym
- SUBLIME
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07624006
- Acronym / sponsor ID
- SUBLIME / RC26_0234
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sublingual sufentani 30 µg | Experimental | Drug: Sublingual sufentanil 30 µg (one dose per hour, as needed) |
| Morphine sulfate | Active comparator | Drug: Morphine sulfate (10 mg every 4 hours as needed) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Sublingual sufentani 30 µg |
| 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. | Drug | Morphine sulfate |
Primary outcome
Postoperative health recovery, evaluated by the score of the modified QoR-15F questionnaire administered at postoperative day 3 (D3).
Time frame: Day 3
QoR-15F questionnaire score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas PERRIN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sublingual sufentanil 30 µg (one dose per hour, as needed) and Morphine sulfate (10 mg every 4 hours as needed) in people with Postoperative Pain, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas PERRIN, MD (03 88 12 70 76 ext. 0033, thomas.perrin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.