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Richard A Pollak, Ira J Gottlieb, Fardin Hakakian, John C Zimmerman, Stewart W McCallum, Randall J Mack, Rosemary Keller, Alex Freyer, Wei Du
OBJECTIVE: To evaluate the analgesic efficacy and safety of a novel intravenous (IV) formulation of meloxicam (30▒mg) in subjects with moderate-to-severe pain following a standardized, unilateral bunionectomy with first metatarsal osteotomy and internal fixation. METHODS: Subjects who met the criteria for moderate-to-severe postoperative pain were randomized to receive bolus injections of meloxicam IV 30▒mg (n=100) or placebo (n=101) administered once daily...
March 16, 2018: Clinical Journal of Pain
Ira J Gottlieb, Deborah R Tunick, Randall J Mack, Stewart W McCallum, Campbell P Howard, Alex Freyer, Wei Du
Objective: This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of an intravenous (IV) nanocrystal formulation of meloxicam in subjects with moderate-to-severe pain following a standardized unilateral bunionectomy. Methods: Fifty-nine subjects aged 18-72 years were randomized to receive doses of either 30 mg (n=20) or 60 mg (n=20) meloxicam IV or placebo (n=19), administered once daily as bolus IV injections over 15-30 seconds (two or three doses)...
2018: Journal of Pain Research
Matthew J Zdilla, Kyle D Miller, Jordan V Swearingen, H Wayne Lambert
Terminal branches of the superficial fibular nerve are at risk of iatrogenic damage during foot surgery, including hallux valgus rigidus correction, bunionectomy, cheilectomy, and extensor hallucis longus tendon transfer. One terminal branch, the dorsomedial cutaneous nerve of the hallux, is particularly at risk of injury at its intersection with the extensor hallucis longus tendon. Iatrogenic injuries of the dorsomedial cutaneous nerve of the hallux can result in sensory loss, neuroma formation, and/or debilitating causalgia...
March 2018: Journal of Foot and Ankle Surgery: Official Publication of the American College of Foot and Ankle Surgeons
Eric So, Vincent H Mandas, Lee Hlad
Treatment of large osseous defects remains a difficult surgical challenge. Autografts and allografts have been known to undergo late collapse, because these options are not specifically designed to withstand the high loads of the foot and ankle. The inability to achieve the correct shape for reconstruction further limits their application. Large osseous defects will result during salvage after failed Lapidus bunionectomy, explantation of failed total ankle replacements, and nonunion of Evans calcaneal osteotomy...
January 2018: Journal of Foot and Ankle Surgery: Official Publication of the American College of Foot and Ankle Surgeons
Neil K Singla, Diana S Meske, Paul J Desjardins
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)...
December 2017: Pain and Therapy
Christopher G Gharibo, Charles Argoff, Joseph A Markenson, Lynn R Webster, Jennifer Nezzer, Daniel Solorio, Melanie Lauterio, Clarence Young
OBJECTIVES: To report the opioid-sparing effects of SoluMatrix indomethacin, developed using SoluMatrix Fine Particle Technology, in a phase 3 study in patients with acute pain following bunionectomy. METHODS: This phase 3, placebo-controlled study randomized 462 patients with moderate-to-severe pain following bunionectomy surgery to receive SoluMatrix indomethacin 40 mg 3 times daily, SoluMatrix indomethacin 40 mg twice daily, SoluMatrix indomethacin 20 mg 3 times daily, celecoxib 400-mg loading dose followed by 200 mg twice daily, or placebo...
February 2018: Clinical Journal of Pain
Panagiotis K Givissis, Panagiotis D Symeonidis, Dimitrios M Kitridis, Dimitrios N Daskalakis, Anastasios G Christodoulou
BACKGROUND: Interposition arthroplasty of the first metatarsophalangeal (MTP) joint is a viable alternative to fusion in patients with advanced hallux rigidus. The purpose of this study is to evaluate the midterm results of a modification of the technique. METHODS: Case series of 18 interposition arthroplasties were performed on 13 female patients with Grade III-IV hallux rigidus. The technique included cheilectomy, bunionectomy when needed, minimal resection of the base of the proximal phalanx and interposition of a fascia lata allograft in the first metatarsophalangeal joint...
August 2017: Foot
Jason H Kim, Sandeep Patel
Although numerous studies have linked smoking with lower extremity wound and bone healing complications, a comprehensive study on the effects of smoking in foot and ankle surgery has not yet been reported. The purpose of the present study was to report the results of our systemic literature review, identifying the effects of tobacco use on common foot and ankle procedures. The systematic literature review was performed according to guidelines set by the PRIMSA statement (Preferred Reporting Items for Systematic Review and Meta-Analyses)...
May 2017: Journal of Foot and Ankle Surgery: Official Publication of the American College of Foot and Ankle Surgeons
Chi Wai Cheung, Stanley Sau Ching Wong, Qiu Qiu, Xianyu Wang
BACKGROUND: Opioids are the mainstay of pain management for acute postsurgical pain. Oral oxycodone is an opioid that can provide effective acute postoperative pain relief. OBJECTIVES: To evaluate the use of oral oxycodone for acute postoperative pain management. STUDY DESIGN: This is a narrative review based on published articles searched in PubMed and Medline from 2003 to 2015 on oral oxycodone for acute postoperative pain management. METHODS: Clinical trials related to the use of oral oxycodone for acute postoperative pain management were searched via PubMed and Medline from 2003 to 2015...
February 2017: Pain Physician
Adam Aubuchon, W David Arnold, Anna Bracewell, J Chad Hoyle
INTRODUCTION: Sciatic neuropathy after popliteal nerve block (PNB) for regional anesthesia is considered uncommon but has been increasingly recognized in the literature. We identified a case of sciatic neuropathy that occurred after bunionectomy during which a PNB had been performed. METHODS: To understand the frequency of PNB-related sciatic neuropathy, we performed a retrospective review of sciatic neuropathies at our center over a 5-year period. RESULTS: Forty-five cases of sciatic neuropathy were reviewed...
October 2017: Muscle & Nerve
Ilhan A Bayhan, Muayad Kadhim, Julieanne P Sees, Tristan Nishnianidze, Kenneth J Rogers, Mehmet S Er, Freeman Miller
This study aimed to evaluate the outcomes of nonarthrodesis surgical treatment of hallux valgus (HV) deformity in children with cerebral palsy using radiographic and gait analysis parameters. There were 25 patients who had hallux valgus correction in 39 feet. The mean age at surgery was 15±2.8 years and the mean follow-up duration was 14.6 months. The first metatarsal osteotomy was performed in nine feet, bunionectomy in 25 feet, and Aiken osteotomy in 32 feet. None had metatarsophalangeal joint fusion. We observed a significant correlation between HV correction and other foot and ankle gait parameters...
March 2017: Journal of Pediatric Orthopedics. Part B
A Erdem Bagatur, Mehmet Albayrak, Yunus Emre Akman, Merter Yalcinkaya, Utku Erdem Ozer, Mehmet Burak Yalcin
A simple, inexpensive technique for fixation of proximal opening-wedge osteotomy of the first metatarsal for correction of moderate or severe hallux valgus (HV) is described. After the opening-wedge osteotomy and bone grafting of the first metatarsal have been performed, 2 Kirschner wires are introduced for internal fixation and removed 8 weeks postoperatively. Twenty-three patients with symptomatic HV who had a proximal medial opening-wedge osteotomy of the first metatarsal in combination with a distal soft tissue procedure and bunionectomy were evaluated retrospectively...
November 1, 2016: Orthopedics
Charles Argoff, Bill McCarberg, Jeff Gudin, Srinivas Nalamachu, Clarence Young
OBJECTIVES: To evaluate opioid rescue medication usage and the opioid-sparing effect of low-dose SoluMatrix® diclofenac developed using SoluMatrix Fine Particle Technology™ in a phase 3 study in patients experiencing pain following bunionectomy surgery. DESIGN: Multicenter, randomized, double-blind, parallel-group study (NCT01462435). SETTING: Four clinical research centers in the United States. SUBJECTS: Four hundred twenty-eight patients aged 18 to 65 years who experienced moderate-to-severe pain following bunionectomy surgery...
October 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Dietmar Dammerer, Matthias Braito, Rainer Biedermann, Michael Ban, Johannes Giesinger, Christian Haid, Michael C Liebensteiner, Gerhard Kaufmann
BACKGROUND: The aim of this study is to assess patients' driving ability when wearing surgical shoes following right-sided first metatarsal osteotomy. METHODS: From August 2013 to August 2015, 42 consecutive patients (mean age 54.5 years) with right-sided hallux valgus deformity underwent first metatarsal osteotomy. Patients were tested for brake response time (BRT) 1 day preoperatively (control run) and at 2 and 6 weeks postoperatively. Two different types of foot orthosis were investigated...
January 20, 2016: Journal of Orthopaedic Surgery and Research
Stephen A Cooper, Paul J Desjardins, Dennis C Turk, Robert H Dworkin, Nathaniel P Katz, Henrik Kehlet, Jane C Ballantyne, Laurie B Burke, Eugene Carragee, Penney Cowan, Scott Croll, Raymond A Dionne, John T Farrar, Ian Gilron, Debra B Gordon, Smriti Iyengar, Gary W Jay, Eija A Kalso, Robert D Kerns, Michael P McDermott, Srinivasa N Raja, Bob A Rappaport, Christine Rauschkolb, Mike A Royal, Märta Segerdahl, Joseph W Stauffer, Knox H Todd, Geertrui F Vanhove, Mark S Wallace, Christine West, Richard E White, Christopher Wu
This article summarizes the results of a meeting convened by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) on key considerations and best practices governing the design of acute pain clinical trials. We discuss the role of early phase clinical trials, including pharmacokinetic-pharmacodynamic (PK-PD) trials, and the value of including both placebo and active standards of comparison in acute pain trials. This article focuses on single-dose and short-duration trials with emphasis on the perioperative and study design factors that influence assay sensitivity...
February 2016: Pain
Eugene R Viscusi, Lynn Webster, Michael Kuss, Stephen Daniels, James A Bolognese, Seth Zuckerman, David G Soergel, Ruth Ann Subach, Emily Cook, Franck Skobieranda
Efficacy of conventional opioids can be limited by adverse events (AEs). TRV130 is a structurally novel biased ligand of the μ-opioid receptor that activates G protein signaling with little β-arrestin recruitment. In this phase 2, randomized, placebo- and active-controlled study, we investigated the efficacy and tolerability of TRV130 in acute pain after bunionectomy. We used an adaptive study design in which 144 patients experiencing moderate-to-severe acute pain after bunionectomy were randomized to receive double-blind TRV130, placebo, or morphine in a pilot phase...
January 2016: Pain
Cynthia Y Robinson, Christopher M Rubino, Stephen J Farr
OBJECTIVES: To assess the single-dose and steady-state pharmacokinetics of a single-entity hydrocodone extended-release (ER) formulation in patients enrolled in two separate phase 2 clinical studies. SETTING: Both studies were multicenter clinical studies. SUBJECTS AND INTERVENTIONS: In study 1, 115 subjects with postsurgical pain (bunionectomy) received single doses of 10, 20, 30, or 40 mg hydrocodone-ER, 10 mg hydrocodone/325 mg acetaminophen immediate-release (IR), or placebo...
September 2015: Journal of Opioid Management
Christopher R Hood, Rhonda S Cornell, Bruce Greenfield
Hypersensitivity reactions to the skin adherents used in postoperative dressings are an uncommon but unfavorable complication that can result in poor wound healing, increased scarring, and surgical wound infections. This unexpected and unforeseen complication is not well documented in the current published data. We present the case of a 39-year-old female who had undergone a bunionectomy procedure and developed allergic contact dermatitis postoperatively. We discuss the clinical findings and treatments administered after application of a commonly used liquid skin adhesive applied intraoperatively...
January 2016: Journal of Foot and Ankle Surgery: Official Publication of the American College of Foot and Ankle Surgeons
José María Lamo-Espinosa, Borja Flórez, Carlos Villas, Juan Pons-Villanueva, José M Bondía, Jesús Dámaso Aquerreta, Matias Alfonso
Some investigators have emphasized restoring the relationship between the sesamoid complex and the first metatarsal head to reduce the risk of hallux valgus recurring after surgical reconstruction. In a prospective study, we analyzed whether the first metatarsophalangeal joint could be realigned after scarf-Akin bunionectomy without lateral soft tissue release. A total of 25 feet, in 22 patients, were prospectively enrolled and analyzed using anteroposterior radiographs and coronal computed tomography scans obtained before and 3 months after surgery...
November 2015: Journal of Foot and Ankle Surgery: Official Publication of the American College of Foot and Ankle Surgeons
Yeung-Jen Chen, Chao-Ching Chiang, Peng-Ju Huang, Jason Huang, Keith Karcher, Honglan Li
OBJECTIVE: To evaluate the efficacy and safety of tapentadol immediate-release (IR) for treating acute pain following orthopedic bunionectomy surgery in a Taiwanese population. METHODS: This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group bridging study in which Taiwanese patients (N = 60) with moderate-to-severe pain following bunionectomy were randomized (1:1:1) to receive tapentadol IR 50 or 75 mg or placebo orally every 4-6 hours over a 72 hour period...
November 2015: Current Medical Research and Opinion
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