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)

NCT07624006 | Not Yet Recruiting Phase 4

• 1 other identifier: RC26_0234
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

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

  QoR-15F questionnaire score

  Day 3

Study Arms (2)

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)

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.

Sublingual sufentani 30 µg

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.

Morphine sulfate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Health Services Needs and Demand; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Thomas PERRIN, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas PERRIN, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 3, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)