Sublingual Sufentanil versus Standard-of-Care (Patient-Controlled Analgesia with Epidural Ropivacaine/Sufentanil or Intravenous Morphine) for Postoperative Pain Following Pancreatoduodenectomy: A Randomized Trial.

Autor:	Groen JV; Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands., Boon SC; Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands., Minderhoud MW; Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands., Bonsing BA; Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands., Martini CH; Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands., Putter H; Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands., Vahrmeijer AL; Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands., van Velzen M; Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands., Vuijk J; Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands., Mieog JSD; Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands., Dahan A; Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands.
Jazyk:	angličtina
Zdroj:	Journal of pain research [J Pain Res] 2022 Jun 22; Vol. 15, pp. 1775-1786. Date of Electronic Publication: 2022 Jun 22 (Print Publication: 2022).
DOI:	10.2147/JPR.S363545
Abstrakt:	Background: The optimal treatment strategy for postoperative pain following pancreatoduodenectomy remains unknown. The aim of this study was to investigate whether sublingual sufentanil tablet (SST) is a non-inferior analgesic compared to our standard-of-care (patient-controlled epidural analgesia [PCEA] or PCA morphine) in the treatment of pain following pancreatoduodenectomy. Methods: This was a pragmatic, strategy, open-label, non-inferiority, parallel group, randomized (1:1) trial. The primary outcome was an overall mean pain score (Numerical Rating Scale: 0-10) on postoperative days 1 to 3 combined. The non-inferiority margin was -1.5 since this difference was considered clinically relevant. Results: Between October 2018 and July 2021, 190 patients were assessed for eligibility and 36 patients were included in the final analysis: 17 patients were randomized to SST and 19 patients to standard-of-care. Early treatment failure in the SST group occurred in 2 patients (12%) due to inability to operate the SST system and in 2 patients (12%) due to severe nausea despite antiemetics. Early treatment failure in the standard-of-care group occurred in 2 patients (11%) due to preoperative PCEA placement failure and in 1 patient (5%) due to hemodynamic instability caused by PCEA. The mean difference in pain score on postoperative day 1 to 3 was -0.10 (95% CI -0.72-0.52), and therefore the non-inferiority of SST compared to standard-of-care was demonstrated. The mean pain score, number of patients reporting unacceptable pain (pain score >4), Overall Benefit of Analgesia Score, and patient satisfaction per postoperative day, perioperative hemodynamics and postoperative outcomes did not differ significantly between groups. Conclusion: This first randomized study investigating the use of SST in 36 patients following pancreatoduodenectomy showed that SST is non-inferior compared to our standard-of-care in the treatment of pain on postoperative days 1 to 3. Future research is needed to confirm that these findings are applicable to other settings. Competing Interests: AD received an educational grant and speaker fees from Grunenthal BV (the Netherlands); grants from MSD, personal fees from Grunenthal, grants from Medasense, grants, personal fees from Enalare, grants from Takeda, grants from AMO Pharma, grants from ZonMW, grants from FDA, grants from LTS Lohmann, grants from Bedrocan, outside the submitted work. Dr Monique van Velzen reports grants from Grunenthal, during the conduct of the study. The authors report no other conflicts of interest in this work. (© 2022 Groen et al.)
Databáze:	MEDLINE
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