Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea

Lee, Y K; Ko, Justin Sangwook; Rhim, Hyou Young; Lee, E J; Karcher, Keith; Li, H; Shapiro, Douglas Y.; Lee, H S

doi:10.1185/03007995.2014.954665

Cited by 15 publications

(20 citation statements)

References 39 publications

(48 reference statements)

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“…Patients randomized into the OF protocol followed a pathway outlined in Table 1 based on prior protocols designed in total shoulder arthroplasty. 21 Preoperatively, each patient received oral meloxicam 15 mg, gabapentin 300 mg, and intravenous (IV) or oral acetaminophen 1000 mg, and a scopolamine patch was placed transdermal prior to transporting to the operating room. Regional anesthesia with a selective nerve ankle block was performed by board-certified anesthesiologists prior to the case using 30 mL of 0.5% ropivacaine using either traditional method or ultrasound guidance depending on anesthesiologist preference.…”

Section: Methodsmentioning

confidence: 99%

Opioid-Free Forefoot Surgery vs Traditional Perioperative Opiate Regimen: A Randomized Controlled Trial

et al. 2022

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Background: In response to the opioid epidemic, the use of multimodal pain management in orthopaedic surgery is increasing. Efforts to decrease opioid prescribing and opioid consumption among foot and ankle surgical patients are needed. The purpose of this study was to compare the efficacy and adverse events between 2 multimodal pain management pathways for forefoot surgical patients: standard opioid-containing (OC) and opioid-free (OF). Methods: This is a single-center noninferior randomized controlled trial of 51 patients undergoing forefoot surgery allocated to one of 2 perioperative pain management treatments: opioid-free, multimodal (OF, n=27 patients), or traditional opioid-containing (OC, n=24 patients). Patient characteristics, creatine markers, pain (numeric rating scale [NRS]), general health (Veterans Rand 12-Item Health Survey [VR-12]), and depression were measured preoperatively. Postoperatively, pain was measured at 24-hour, 2-week, and 6-week time points. Satisfaction with pain control, complications, and general health were measured at 2 and 6 weeks. Results: The OF group is statistically noninferior to the OC group and reported lower median pain scores at 24 hours (2 [IQR 0, 3] vs 6 [IQR 3.5, 7]; p<.0001) and 2 weeks (2 [IQR 1, 4] vs 4 [IQR 0, 3]; p=.018]. By 6 weeks, pain levels were similar between groups. More than 85% of all patients reported satisfaction with pain level at 2 weeks, which increased to >90% at 6 weeks. The VR-12 scores were similar between groups across all time points. At 2 weeks, 8 patients in each group reported constipation. By 6 weeks, all but 2 OC patients reported resolution. No other adverse events of postoperative wound complications, readmissions, medication reactions, thrombosis, or persistent pain were documented. Conclusion: In forefoot surgery, the opioid-free pain management protocol was statistically noninferior to the opioid-containing protocol in reducing postoperative pain. Level of Evidence: Level II, prospective cohort study.

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Section: Methodsmentioning

confidence: 99%

Opioid-Free Forefoot Surgery vs Traditional Perioperative Opiate Regimen: A Randomized Controlled Trial

et al. 2022

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“…In placebo-controlled acute post-surgical pain studies, provisions must be made for study subjects to receive adequate analgesic therapy. As such, most protocols allow study subjects to receive a pre-specified regimen of open-label analgesic drugs (rescue drugs) on an as-needed basis [ 1 – 6 , 8 – 10 , 13 – 15 , 17 , 19 , 20 , 25 – 27 , 29 – 34 , 36 , 39 , 40 ]. These drugs are administered only if the blinded study drug (active or placebo) fails to adequately relieve the subject’s pain.…”

Section: Introductionmentioning

confidence: 99%

Exploring the Interplay between Rescue Drugs, Data Imputation, and Study Outcomes: Conceptual Review and Qualitative Analysis of an Acute Pain Data Set

Singla

Meske

Desjardins³

2017

Pain Ther

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In placebo-controlled acute surgical pain studies, provisions must be made for study subjects to receive adequate analgesic therapy. As such, most protocols allow study subjects to receive a pre-specified regimen of open-label analgesic drugs (rescue drugs) as needed. The selection of an appropriate rescue regimen is a critical experimental design choice. We hypothesized that a rescue regimen that is too liberal could lead to all study arms receiving similar levels of pain relief (thereby confounding experimental results), while a regimen that is too stringent could lead to a high subject dropout rate (giving rise to a preponderance of missing data). Despite the importance of rescue regimen as a study design feature, there exist no published review articles or meta-analysis focusing on the impact of rescue therapy on experimental outcomes. Therefore, when selecting a rescue regimen, researchers must rely on clinical factors (what analgesics do patients usually receive in similar surgical scenarios) and/or anecdotal evidence. In the following article, we attempt to bridge this gap by reviewing and discussing the experimental impacts of rescue therapy on a common acute surgical pain population: first metatarsal bunionectomy. The function of this analysis is to (1) create a framework for discussion and future exploration of rescue as a methodological study design feature, (2) discuss the interplay between data imputation techniques and rescue drugs, and (3) inform the readership regarding the impact of data imputation techniques on the validity of study conclusions. Our findings indicate that liberal rescue may degrade assay sensitivity, while stringent rescue may lead to unacceptably high dropout rates.

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“…Показано, что у пациентов после ортопедических вмешательств тапентадол НВ сильнее уменьшал интенсивность острой боли, чем плацебо. НЯ регистрировались в 2 раза чаще в группе тапентадола, чем в группе плацебо [15]. В РКИ Y.J.…”

Section: клинические исследования эффективности тапентадола нв в послеоперационном периодеunclassified

Tapentadol in acute pain: a review of the results of international studies

Nikoda

2021

Sovremennaâ revmatologiâ

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The treatment of acute pain is a fundamental goal for doctors of various specialties. Tapentadol, which combines the properties of an opioid receptor agonist and a noradrenalin reuptake inhibitor, is one of the most popular analgesics in the world that is effective in severe acute pain. We provide a review of international publications about pharmacological properties, efficacy and safety of tapentadol immediate release (IR) in acute pain. Data from phase II and III of randomized controlled trials (RCTs), in which tapentadol IR (50, 75 and 100 mg) was used for moderate to severe pain in surgical and therapeutic practice is discussed. A number of studies have compared tapentadol with placebo groups and classical opioids (oxycodone, morphine). The results of two meta-analyzes and systematic reviews of efficacy and safety of this analgesic in patients with acute pain are presented.International multicenter RCTs have demonstrated high efficacy of tapentadol IR 50, 75 and 100 mg in patients in the early postoperative period. Comparison with other opioid analgesics showed that tapentadol was superior to placebo and comparable to oxycodone in analgesic effect.It was concluded that tapentadol has a better safety and tolerability profile than classical opioids. The incidence of adverse events on this drug is lower than on oxycodone or morphine.

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Acute postoperative pain relief with immediate-release tapentadol: randomized, double-blind, placebo-controlled study conducted in South Korea

Cited by 15 publications

References 39 publications

Opioid-Free Forefoot Surgery vs Traditional Perioperative Opiate Regimen: A Randomized Controlled Trial

Opioid-Free Forefoot Surgery vs Traditional Perioperative Opiate Regimen: A Randomized Controlled Trial

Exploring the Interplay between Rescue Drugs, Data Imputation, and Study Outcomes: Conceptual Review and Qualitative Analysis of an Acute Pain Data Set

Tapentadol in acute pain: a review of the results of international studies

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