The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic

Sufentanil, unlike morphine and hydromorphone, avoids the issue of active metabolites that can lead to prolonged, untoward effects, which can complicate postoperative care and affect patient discharge. One study found that sufentanil SL 30 mcg was well tolerated, with no unexpected adverse events, no clinically meaningful vital sign changes, and a safety profile that was as expected for this postoperative patient population. In addition, the use of sufentanil SL in the emergency department indicates that sufentanil SL was a potentially feasible option for managing moderate-to-severe acute pain in that setting. Another study of adult patients undergoing major surgery in five hospitals in the Netherlands who received the sufentanil SL for postoperative pain relief as part of multimodal pain management showed that sufentanil SL effectively managed postoperative pain in abdominal and orthopedic surgeries. Finally, a randomized, open-label non-inferiority study that enrolled patients scheduled for elective major open abdominal or orthopedic surgery assessed the proportion of patients who responded "good" or "excellent" at the 48-hour timepoint on the Patient Global Assessment of method of pain control. The results showed that 78.5% vs. 65.6% of patients achieved "success" for sufentanil SL vs. intravenous patient-controlled analgesia (morphine), respectively, demonstrating non-inferiority as well as statistical superiority for treatment effect. Patients using sufentanil SL reported more rapid onset of analgesia and patient and nurse ease of care and satisfaction scores were higher than intravenous patient-controlled analgesia (morphine). Adverse events were similar between the 2 groups, and sufentanil SL had fewer patients experiencing oxygen desaturations below 95% compared to intravenous patient-controlled analgesia (morphine). Future studies are needed to determine patient populations that benefit most from the sufentanil SL, assess the added values versus intravenous patient-controlled analgesia, and determine the pharmacoeconomics of the system.

Purpose:

In this study the investigators plan to examine the perioperative use sufentanil SL in the analgesic regimen for spine surgery, one of the most common surgeries performed in the United States. Patients undergoing spinal fusion surgery often experience severe pain during the first three postoperative days. Currently, no data are available for this patient population which routinely experiences moderate to severe acute pain. The investigators will analyze whether sufentanil SL is associated with lower opioid consumption, number of fentanyl boluses given, post-anesthesia care unit and hospital length of stay, side effects of opioid use (i.e., nausea, vomiting, constipation), and hospitalization costs (i.e., pharmacoeconomics).

Hypotheses:

1. The perioperative use of sufentanil SL 30 mcg in a prospective cohort of patients undergoing spine surgery will be associated with lower postoperative numeric rating scale pain scores (numerical rating score (NRS); primary outcome) than observed in two historical control groups that did not receive sufentanil SL: one group that received intraoperative remifentanil infusion and one that received intraoperative sufentanil infusion.
2. The perioperative use of sufentanil SL will be associated with lower opioid consumption, number of fentanyl boluses given, post-anesthesia care unit length of stay than observed in two historical control groups of patients receiving remifentanil or sufentanil infusions without perioperative sufentanil SL.