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) (SUBLIME)

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 Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Sublingual sufentanil 30 µg (one dose per hour, as needed); Drug: Morphine sulfate (10 mg every 4 hours as needed)

• Study Type: Interventional
• Enrollment (Estimated): 1150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Thomas PERRIN, MD; Phone Number: 0033 03 88 12 70 76; Email: thomas.perrin@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Hôpitaux Universitaires de Strasbourg
    • Contact: Thomas PERRIN, MD; Phone Number: 0033 03 88 12 70 76; Email: thomas.perrin@chru-strasbourg.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sublingual sufentani 30 µg	Drug: 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.
Active Comparator: Morphine sulfate	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Thomas PERRIN, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Alkaloids; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Health Care Economics and Organizations; Heterocyclic Compounds, 4 or More Rings; Morphinans; Opiate Alkaloids; Heterocyclic Compounds, Bridged-Ring; Phenanthrenes; Morphine Derivatives; Health Planning; Health Services Research; Morphine; Health Services Needs and Demand
• Other Study ID Numbers: RC26_0234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No