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Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study.

ABSTRACT: PURPOSE:Effectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol. METHODS:This pragmatic, parallel, open label, randomized controlled, trial enrolled 72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway. In addition to multimodal analgesia, patients received SSTS 15 mcg (SSTS group) or oral oxycodone extended release 10?mg twice daily and oral oxycodone immediate-release 5?mg up to four times daily on demand (Oxy group) to control pain during 48?h postoperatively. The primary endpoint was pain measured using a numeric rating scale at 24?h postoperatively. Time to first mobilization, side effects and patient satisfaction were also recorded. RESULTS:Median pain score at 24?h at rest was 3 [2-4] for Oxy group vs 2 [1.75-3] for SSTS group (p?=?0.272) whereas median pain score on movement was 4 [3-6] vs 3 [2-5] respectively (p?=?0.059). No difference in time to first mobilization was found between the two groups. The method of pain control was judged good/excellent for 83.9% of patients in the SSTS group compared with 52.9% in the Oxy group (p?=?0.007). The incidence of nausea was 33% in SSTS group and 9% in Oxy group (p?=?0.181). CONCLUSIONS:In complement to ERAS multimodal analgesia, sublingual sufentanil 15 mcg tablet system did not show clinically significant pain improvement compared to oral oxycodone after total knee arthroplasty. TRIAL REGISTRATION:Clinical Trials: NCT04448457 ; retrospectively registered on June 24, 2020. https://clinicaltrials.gov/ct2/show/NCT04448457?cond=sublingual+sufentanil&cntry=BE&draw=2&rank=3.

SUBMITTER: Noel E

PROVIDER: S-EPMC7679427 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study.

Noel Emmanuel E Miglionico Luca L Leclercq Mickael M Jennart Harold H Fils Jean-François JF Van Rompaey Nicolas N

Journal of experimental orthopaedics 20201120 1

<h4>Purpose</h4>Effectiveness of sufentanil sublingual tablet system (SSTS) compared to oral oxycodone in the management of postoperative pain after total knee arthroplasty (TKA) within an enhanced recovery after surgery (ERAS) protocol.<h4>Methods</h4>This pragmatic, parallel, open label, randomized controlled, trial enrolled 72 adult patients scheduled for TKA under spinal anesthesia following ERAS pathway. In addition to multimodal analgesia, patients received SSTS 15 mcg (SSTS group) or oral ...[more]

PMID: 33216238

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Project description:ObjectiveTo evaluate sufentanil sublingual tablet 30 mcg (SST 30 mcg) for postoperative pain in an older patient population with comorbidities.DesignMulticenter, open-label, single-arm study.SettingNine hospitals across the United States.SubjectsAdults aged ≥40 years who had undergone a surgical procedure.MethodsPatients with a postoperative pain intensity score ≥4 on an 11-point numeric rating scale (NRS) were allowed to enter the study and receive SST 30 mcg as requested for pain (minimum 60-minute redosing interval) over the 12-hour study period. Efficacy was assessed by patient reports of pain intensity on the NRS and a five-point pain relief scale. Safety was monitored throughout the study; plasma sufentanil concentrations were also measured. The primary efficacy endpoint was the time-weighted summed pain intensity difference (SPID) to baseline over 12 hours (SPID12).ResultsOf the 140 patients enrolled, 69% were American Society of Anesthesiologists Physical Class II or III, 44% had a body mass index (BMI) ≥30 mg/kg2, and 29% had hepatic and/or renal impairment. Average age was 54.7 years (SD = 9.9 years), and average baseline pain intensity was 6.2 (SD = 1.9). The most common surgeries were abdominal (59%) and orthopedic (20%). The mean SPID12 was 36.0 (standard error of the mean = 2.2); mean scores were similar, regardless of age, sex, race, and BMI. From baseline, mean pain intensity decreased significantly starting 30 minutes postdose, and mean pain relief increased significantly starting 15 minutes postdose, remaining relatively stable through 12 hours (P < 0.001 at each time point). Four (3%) patients discontinued due to inadequate analgesia, and 45 (32%) patients had one or more adverse events that were considered possibly or probably related to the study drug. Mean plasma sufentanil concentrations were generally similar regardless of age, sex, BMI, or organ impairment status.ConclusionsSST 30 mcg was effective and well tolerated for the management of moderate-to-severe acute postoperative pain.

Project description:IntroductionEarly postoperative pain following total knee arthroplasty significantly impacts outcomes and patient satisfaction. However, the characteristics and sources of early pain after total knee arthroplasty remain unclear. Therefore, the purpose of this study was to determine the anatomic distribution and course of postoperative pain in the acute and subacute period following total knee arthroplasty.MethodsA prospective observational study of primary, elective unilateral total knee arthroplasty cases was conducted at our academic tertiary care medical center from January 2021 to September 2021. Preoperative variables were extracted from institutional electronic medical records. Postoperatively, patients utilized a knee pain map to identify the two locations with the most significant pain and rated it using the visual analog scale (VAS). The data were collected on day 0, at 2 weeks, 2 months, and 6 months after operation.ResultsThis study included 112 patients, with 6% of patients having no pain at postoperative day 0, 22% at 2 weeks, 46% at 2 months, and 86% at 6 months after operation. In those who reported pain, the VAS score (mean ± standard deviation) was 5.8 ± 2.4 on postoperative day 0 and decreased at each follow-up time point (5.4 ± 2.3 at 2 weeks, 3.9 ± 2.2 at 2 months, and 3.8 ± 2.7 at 6 months). The majority of patients were able to identify distinct loci of pain. The most common early pain loci were patellae, thigh, and medial joint line, and this distribution dissipated by 6 months.ConclusionAt 2 postoperative weeks, pain was primarily at the medial joint, and at 6 months postoperatively, pain was more likely to be at the lateral joint. No relationship was found between pain at six months and pain scores or location at postoperative day 0 or 2 weeks. Understanding the distribution and progression of knee pain following total knee arthroplasty may benefit patient education and targeted interventions.Level of evidenceLevel II, prospective observational study.

Dataset Information

Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study.

Publications

Sufentanil sublingual tablet system versus oral oxycodone for management of postoperative pain in enhanced recovery after surgery pathway for total knee arthroplasty: a randomized controlled study.

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