Journal of Pain Research (Jun 2022)

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

  • Groen JV,
  • Boon SC,
  • Minderhoud MW,
  • Bonsing BA,
  • Martini CH,
  • Putter H,
  • Vahrmeijer AL,
  • van Velzen M,
  • Vuijk J,
  • Mieog JSD,
  • Dahan A

Journal volume & issue
Vol. Volume 15
pp. 1775 – 1786

Abstract

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Jesse Vincent Groen,1 SC Boon,2 MW Minderhoud,2 Bert A Bonsing,1 CH Martini,2 H Putter,3 AL Vahrmeijer,1 Monique van Velzen,2 J Vuijk,2 JSD Mieog,1,* A Dahan2,* 1Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands; 2Department of Anesthesiology, Leiden University Medical Center, Leiden, The Netherlands; 3Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands*These authors contributed equally to this workCorrespondence: A Dahan, Department of Anesthesiology, Leiden University Medical Center, Albinusdreef 2, Leiden, 2300 RC, The Netherlands, Tel +31 71 526 2301, Email [email protected]: 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.Keywords: postoperative pain, pancreatoduodenectomy, sufentanil, epidural analgesia, morphine

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