Patient-controlled sublingual sufentanil tablet system versus intravenous opioid analgesia for postoperative pain management after lumbar spinal fusion surgery

This was a monocentric, retrospective, matched (1:1) cohort study designed to investigate the effect of a change in the spine surgery department's practice, i.e., the postoperative administration of an SSTS after single- or two-level spinal fusion surgery. The study was approved by the ethics committee of the University Hospital Jena, Germany (No. 2021–2433-Daten). All methods were carried out according to relevant guidelines and regulations based on the approval. Written informed consent for patient information and images to be published was provided by the patients or a legally authorized representative.

Patients were included if they were scheduled to undergo primary single- or two-level spinal fusion surgery with a posterior approach due to single- or two-level lumbar segment degeneration with associated back pain and radiculopathy. Cases of mental health and physical problems, previous lumbar surgery, multilevel (> 2) lumbar fusion surgery, opioid-tolerant patients (use of > 15 mg oral morphine equivalent per day within the past three months), and alcohol or drug abuse were excluded to prevent falsification through a potentially changed perception of pain or application error in the postoperative PCA. In addition, documented sleep apnea or a need for outpatient oxygen therapy was contraindications for PCA.

Group size was calculated using G*Power Version 3.1 (University of Düsseldorf, Germany) for the main outcome parameter (NRS), except for an effect size of f = 0.35 (medium-to-strong effect; α = 0.05, ß = 0.2, repeated measures correlation coefficient of 0.85 based on postoperative NRS measurements of a historical cohort) for 6 measurement time points (repeated measures ANOVA), resulting in a total sample size of 60 patients (30 per group).

Two groups were defined by the kind of patient-controlled postoperative analgesia application during the first 48 h after surgery (group SSTS and group IV-PCA).

Based on known factors associated with postoperative pain and the operative course, the groups were matched (1:1) for age, body mass index, HADS, and type of surgery (single- or two-level lumbar fusion surgery) [9].

Treatment with the SSTS was initiated as another option for standard therapy in patients undergoing lumbar fusion surgery from January 2020 to December 2020. The SSTS (Zalviso®, Grünenthal, Aachen, Germany) has a preprogrammed 20-min lockout interval and uses a radiofrequency identification (RFID) thumb tag to personalize the device upon setup of the system, which is completed without a need for programming decisions. The nurse inserts a small cartridge containing 40 sufentanil tablets into the dispenser tip, locked into the controller base, and the system is tethered to the bedside or other secure locations. The controller base has a graphic user interface screen that facilitates patient training by the nurse and displays setup instructions and system data for authorized healthcare professionals. Sublingual sufentanil has a 300 to 400 potency factor and 60% bioavailability compared to IV morphine. One sufentanil tablet contains 15 μg. The synthetic opioid piritramide was used for IV-PCA. Piritramide is a long-lasting opioid with an equianalgesic potential of 0.65–0.75 to standard morphine and is frequently used to manage postoperative pain [10]. Consequently, the sufentanil dose in the SSTS, which is available every 20 min, reflects an approximately equianalgesic dose to the standard 1 mg piritramide that is on demand every 5 min with typical IV-PCA settings (approximately 3 mg IV-Morphine equivalent every 20 min for both groups).

Based on our standard hospital protocol, IV opioids were allowed as needed for analgesia during surgery. All patients were operated on under general anesthesia. Following surgery, IV morphine, hydromorphone, or fentanyl were administered as required to keep the patient comfortable in the postanesthesia care unit (PACU). Antiemetic prophylaxis and treatment were allowed.

Patients leaving the PACU who did not require further intensive medical care after lumbar fusion surgery were treated with either the SSTS (15 µg sufentanil every 20 min) or IV-PCA (1 mg piritramide every 5 min) in random allocation. The maximum dose was limited to 30 mg piritramide per day. The duration of treatment using postoperative PCA (SSTS or IV-PCA) was 48 h. Thus, the approximately maximum available morphine equivalent dose over 48 h was 140 mg of IV-morphine in the SSTS group and 45 mg of IV-morphine in the IV-PCA group.

Postoperative PCA was part of multimodal pain management that included IV acetaminophen (1 g on demand four times daily) and oral metamizole (1 g three times daily).

Data gathering was performed uniformly by the same person [11] for all groups since the data were gathered as part of standard treatment. Based on the current average hospital stay in this country after a single- or two-level lumbar fusion surgery of 7–8 days (5–7 days in our hospital), retrospective data collection was performed for 5 days postoperatively. The following baseline characteristics were collected: age, sex, body mass index (BMI), and American Society of Anesthesiologists score [7]. To determine the difference in anxiety and depression between the groups, all patients were assessed before surgery using the hospital anxiety and depression scale (HADS). The HADS is an easy-to-use questionnaire with already proven validity and reliability consisting of 14 questions that examine the symptoms of depression with seven questions and the symptoms of anxiety with seven questions [12]. Total scores between 0 and 7 indicate no abnormality; scores of 8 and above indicate anxiety or depression [13].

The primary outcome parameters, pain intensity, and frequency of pain were assessed on an NRS, where 0 = no pain and 10 = worst possible pain and 0 = no pain and 10 = persistent pain, respectively. The daily average NRS score was collected from both groups until the 5th postoperative day. At this, patients were asked about their average pain intensity and pain frequency once a day as part of the daily medical consultation. Secondary outcome parameters included nausea, early mobilization following surgery (no later than the 1st day following surgery), and patient satisfaction. Satisfaction with the treatment was assessed using the MacNab criteria with four levels of categorization: excellent, good, fair, and poor [14].

All outcome parameters were compared between the groups.

留言 (0)

沒有登入
gif