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)

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

1,150 Participants
are divided into 2 treatment groups
Group A: Sublingual sufentani 30 µgExperimental treatment 1 intervention
Group B: Morphine sulfateActive comparator 1 intervention

Trial outcomes

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

Time frame
Day 3

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: