Sufentanil sublingual tablet system for enhanced recovery after total knee arthroplasty: a prospective observational case study

Design and patients

In order to assess the effectiveness of our enhanced recovery program, and the potential interest of using SSTS in our unit, we conducted a prospective observational single-center study at Angers University Hospital between March 1, 2018, and March 1, 2019. The study was approved by the local Ethical Committee (Comité d’Ethique du CHU d’Angers, reference number 2018-13). Inclusion criteria were patients scheduled to be operated on for primary unilateral knee arthroplasty in the enhanced recovery pathway of our center and age ≥ 18 years old.

Two groups of patients were compared in this case study, those who received the SSTS (SL-sufentanil group) and those who received a morphine PCA (IV-morphine group). To assess early recovery, the primary endpoint of our study was the postoperative TUG measured at day 1, day 2, and day 3 after surgery. Secondary endpoints included perioperative pain (assessed by the numerical rating scale of pain), opioid consumption, opioid adverse effects, knee flexion, time of the venous cannula removal, length of stay in the postanesthesia care unit (PACU), and total length of hospital stay. Morphine equivalents were calculated according to one of the usual rules (Shaheen et al. 2009) which was here: oral oxycodone 1 mg = intravenous morphine 0.5 mg and sublingual sufentanil 15 μg = intravenous morphine 2.5 mg.

Results are presented as numbers (%) and medians [interquartiles 25–75%]. Categorical variables were compared between groups using Fisher’s test. Qualitative variables were compared between groups or between perioperative times (for the TUG) using Mann-Whitney test. Statistical analyses were performed using the JMP software (SAS, USA).

Perioperative management of patients in the enhanced recovery pathway

Total knee arthroplasties were performed under general or spinal anesthesia, and unless contraindicated, all patients received both a periarticular infiltration and a preoperative adductor canal block.

The SSTS was allocated as usual in our center, according to its availability (3 devices only in our unit) when the patient arrived in the recovery room after surgery, and was started from the recovery room for a maximal period of 72 h. Patients for whom a SSTS device was not available were prescribed an intravenous morphine PCA (settings: bolus 1 mg, refractory period: 7 min, maximum dose: 20 mg for 4 h) for a maximum duration of 72 h. The computerized prescription of our unit procedure indicated however to relay the morphine PCA as soon as possible by oral immediate release oxycodone (5 mg on demand every 4 h for pain with numerical scale above than 3) and to remove the peripheral venous cannula as soon as an intravenous infusion was no longer needed. In PACU, analgesic titration was performed with intravenous morphine for patients in the IV-morphine group, although it could be performed immediately with the STSS and/or with IV morphine in the SL-sufentanil group.

In the enhanced recovery pathway of our postoperative orthopedic unit, all patients received early postoperative physiotherapy, including a daily Timed Up and Go Test (TUG) when possible. This test has been well evaluated and validated to measure physical recovery after surgery (Alrawashdeh et al. 2021). Knee flexion measurements were recorded by the physiotherapists as usual. No change was made in the perioperative management of patients.

Preoperative characteristics and intraoperative data

Thirty patients were included between March 2018 and March 2019, 15 in the IV-morphine group and 15 in the SL-sufentanil group. The pre- and intra-operative characteristics of the patients were similar between the 2 groups, in particular concerning the preoperative analgesic consumption, the duration of the procedure, and the anesthetic techniques used (Tables 1 and 2).

Table 1 Preoperative dataTable 2 Intra-operative dataPostoperative physical rehabilitation

There were no significant differences in terms of postoperative physical rehabilitation assessed by the TUG between the two groups from day 1 to day 3 after surgery (Fig. 1), nor between the postoperative/preoperative TUG ratios at these different times. In addition, knee mobilities were similar between the 2 groups (Table 3).

Fig. 1figure 1

Perioperative times obtained with the Timed Up and Go (TUG) test. There were no significant differences between the IV-morphine and SL-sufentanil groups from day 1 to day 3

Table 3 Postoperative data related to pain and mobilizationPostoperative pain

Postoperative pain measured at rest and on exertion (during the TUG) was not significantly different between the two groups from day 0 to day 3 (Table 3). The total of IV morphine equivalents consumed in the surgical ward or both in the PACU and the surgical ward was significantly greater in the SL-sufentanil group. The number of requests and really received doses with either the SSTS or the morphine-PCA were also greater, although not significantly, in the SL-sufentanil group. However, the number of oxycodone tablets used was significantly greater in the IV-morphine group. The number of side effects attributable to opioid use was similar between the IV-morphine and SL-sufentanil groups (Table 3).

Other results

Patients in the SL-sufentanil group had their peripheral venous cannula removed earlier than in IV-morphine group, but there were no significant differences in the length of stay in the postanesthesia care unit and in the total length of hospital stay (Table 3).

Finally, as outcomes regarding postoperative pain and mobilization may differ depending of the type of anesthesia received (Bourget-Murray et al. 2022; Johnson et al. 2016; Memtsoudis et al. 2019; Sciberras et al. 2022), we conducted a post hoc analysis in patients operated on under general anesthesia only (i.e., after removal of patients who have had a spinal anesthesia). Results of comparisons between the IV-morphine group and the SL-sufentanil group were similar than those obtained on the whole group patients, with in particular a greater morphine equivalents consumption in the SL-sufentanil group and no significant differences in postoperative pain, times to complete the TUG, knee flexions, and lengths of hospital stay (Additional file 1, Table S1). Only pain on exertion at day 1 was significantly higher in the SL group (Table S1).

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