Étude pilote : implémentation du système d'administration de sufentanil par voie sublinguale en comparaison à l'analgésie intraveineuse contrôlée par le patient après arthroplastie de la hanche au Centre Hospitalier du Bois de l'Abbaye

Abstract

Title : Pilot study: implementation of the sublingual Sufentanil administration system compared to Patient-controlled intravenous analgesia after hip arthroplasty at the Centre Hospitalier du Bois de l’Abbaye. Objective : The objective of this research project is to determine the added value, in terms of efficacy, satisfaction, budget and safety of the Sublingual sufentanil delivery system (SASS) in comparison to Patient-controlled intravenous analgesia (ACPiv) during the first postoperative 48 hours. Methods : This is an experimental study whose method of sampling includes for convenience patients (n = 80) with unicompartmental hip arthroplasty under centromedullary anaesthesia divided into two groups. The recovery room and orthopaedic care teams were consulted to assess their satisfaction with the use of each of the two systems. Data collection was made using self-administrated queries. Results : The overall patient satisfaction score is 4.5 for the SASS group and 4.2 for the ACPiv group. The median satisfaction score for the general pain control level and in relation to the treatment are similar within each group. They are respectively of 9 for the SASS group and of 8 for the ACPiv group. The SASS obtains an overall satisfaction score of 1.3 by the health care staff of the recovery room and of 1.0 by the orthopaedic ward nursing team. The ACPiv obtains a better score (1.0) in the recovery room and a lower score in the orthopaedic ward (1.5). The average cost for the purchase of the SASS is 1290,7 € excluding VAT and 3807 € excluding VAT for the ACPiv. After 48h, the pain intensity (EVA) is significantly better with the SASS (2.0) than with the ACPiv (3.0). This finding may influence several factors in between groups (SASS vs ACPiv): the demand for additional analgesic (0% vs 42.5%), the number of side effects (51.0 vs 56.0), the estimate of the relief as "excellent" or "good" (89.4% vs 80.0%), the median number of delivered doses (13.0 vs 21.0) and rejected doses (1.0 vs 27.5) as well as the presence of a peripheral iv catheter (2.5% vs 45.0%). The safety criterion did not identify any problem with the devices. Multivariate analysis shows that the number of rejected requests is higher with the use of ACPiv and that the freedom of movement is better with the SASS. Conclusions : According to the results, SASS offers a very interesting alternative to ACPiv in the context of unicompartmental hip arthroplasty under centromedullary anaesthesia. However, SAAS financing and the reimbursement of consumables could prevent the development of the project. Key Words : Patient-controlled analgesia, sufentanil, postoperative pain, sublingual tablet system, opioid.