Primary Decompressive Craniectomy: Effects on Neurocritical Care Management, Long-Term Neurologic Status and Mortality

Objectives: Decompressive craniectomy (DC) is a surgical therapy used to treat patients foreseen to be at risk for high intracranial pressure (ICP). In this retrospective case control study, mortality, ICP values, neurocritical care (NCC) management necessity, and long-term neurologic status were examined in patients treated with DC and in a matched control group. Methods: The primary end-points were all-cause mortality and functional status of NCC patients both at discharge and at a 6 month follow-up. Secondary end-points were ICP values at established time points and the use of advanced NCC therapies. Patients who underwent primary DC were matched with individuals with similar demographic and pre-intervention ICP values who had been treated with standard NCC management alone. Results Neurologic status outcome at discharge and the 6 month follow-up was significantly better in patients treated with DC compared to those in the control group: Glasgow Outcome Scale (GOS) 4-5 in 15 versus 5 patients; p = 0.033, and 16 versus 6 patients, p = 0.033. Mortality at 6 months was similar in the study groups (10 versus 16 patients; p = 0.212). ICP values were similar at NCC admission but were better controlled 24 hours after DC than in the control group. Fewer patients treated with DC needed advanced NCC medical therapies. Conclusions: DC is an effective way to normalize ICP levels while reducing the need for aggressive medical therapies. Survival rate and neurological outcome in patients treated with DC were found to be better than in those receiving only medical treatment

Study of Peri-Articular Anaesthetic for Replacement of the Knee (SPAARK): study protocol for a patient-blinded, randomised controlled superiority trial of liposomal bupivacaine

Background: Optimising the management of peri-operative pain and recovery following knee replacement has been identified as a patient priority. Current pain relief strategies use opiate-based analgesia; however, up to 50% of patients experience significant side effects. Local anaesthetic incisional infiltration is one alternative. The length of the duration of action is a major limiting factor of current local anaesthetic techniques. Liposomal bupivacaine has been reported to be effective for up to 72 h. This randomised controlled trial will evaluate the clinical and cost effectiveness of liposomal bupivacaine. Methods: SPAARK is a patient-blinded, multi-centre, active comparator, superiority, two-arm, parallel-group randomised controlled trial. Five hundred patients undergoing knee replacement will be recruited and randomised to liposomal bupivacaine plus bupivacaine hydrochloride or bupivacaine hydrochloride alone. The co-primary outcomes are the Quality of Recovery 40 measured at 72 h post-surgery and also cumulative pain measured daily using a 0–10 visual analogue scale for the first 3 days following surgery. Secondary outcomes include cumulative opioid consumption, fitness for discharge, functional outcomes assessed using the Oxford Knee Score and American Knee Society Score, the EuroQol five dimensions instrument and complications. A cost utility analysis is also planned. Discussion: The clinical effectiveness and cost effectiveness of liposomal bupivacaine have yet to be evaluated in the National Health Service, making this trial appropriate and timely. Trial registration: ISRCTN registry, ISRCTN54191675. Registered on 14 November 2017

Prevention and Treatment of Postoperative Nausea and Vomiting (PONV): A Review of Current Recommendations and Emerging Therapies

Zhaosheng Jin,1 Tong J Gan,1 Sergio D Bergese1,2 1Department of Anesthesiology, Stony Brook University Health Science Center, Stony Brook, NY 11794-8480, USA; 2Department of Neurological Surgery, Stony Brook University Health Science Center, Stony Brook, NY 11794-8480, USACorrespondence: Sergio D BergeseStony Brook University Health Science Center, Stony Brook, NY 11794-8480, USATel +1 631-444-2975Email [email protected]: Postoperative nausea and vomiting is one of the most frequent adverse events after surgery and anesthesia. It is distressing for the patient and can lead to other postoperative complications. Management of PONV involves a framework of risk assessment, multimodal risk reduction, and prophylactic measures, as well as prompt rescue treatment. There has been a significant paradigm shift in the approach towards PONV prevention. There have also been several emerging therapeutic options for PONV prophylaxis and treatment. In this review, we will discuss the up-to-date PONV management guidelines and highlight novel therapeutic options which have emerged in the last few years.Keywords: antiemetics, enhanced recovery after surgery, postoperative care, postoperative nausea and vomitin

Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia

Sergio D Bergese1, Sonia Ramamoorthy2, Gary Patou3, Kenneth Bramlett4, Stephen R Gorfine5, Keith A Candiotti61Department of Anesthesiology and Neurological Surgery, Ohio State University, Columbus, OH, USA; 2Department of Surgery, University of California at San Diego, La Jolla, CA, USA; 3Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA; 4Private Practice, Alabama Orthopaedic Institute, Birmingham, AL, USA; 5Department of Surgery, The Mount Sinai Medical Center, New York, NY, USA; 6Department of Anesthesiology, University of Miami, Miami, FL, USABackground: Liposome bupivacaine is a novel formulation of the local anesthetic bupivacaine, designed to provide prolonged postsurgical analgesia. This analysis examined pooled efficacy data as reflected in cumulative pain scores from 10 randomized, double-blind liposome bupivacaine clinical studies in which the study drug was administered via local wound infiltration.Methods: A total of 823 patients were exposed to liposome bupivacaine in 10 local wound infiltration studies at doses ranging from 66 mg to 532 mg in five surgical settings; 446 patients received bupivacaine HCl (dose: 75–200 mg) and 190 received placebo. Efficacy measures were assessed through 72 hours after surgery.Results: Overall, 45% of patients were male and 19% were ≥65 years of age. In the analysis of cumulative pain intensity scores through 72 hours, liposome bupivacaine was associated with lower pain scores than the comparator in 16 of 19 treatment arms assessed, achieving statistically significant differences compared with bupivacaine HCl (P < 0.05) in five of 17 treatment arms. These results were supported by results of other efficacy measures, including time to first use of opioid rescue medication, proportion of patients avoiding opioid rescue medication, total postsurgical consumption of opioid rescue medication, and patient/care provider satisfaction with postoperative analgesia. Local infiltration of liposome bupivacaine resulted in significant systemic plasma levels of bupivacaine, which could persist for 96 hours; systemic plasma levels of bupivacaine following administration of liposome bupivacaine were not correlated with local efficacy. Liposome bupivacaine and bupivacaine HCl were generally well tolerated.Conclusion: Based on this integrated analysis of multiple efficacy measures, liposome bupivacaine appears to be a potentially useful therapeutic option for prolonged reduction of postsurgical pain in soft tissue and orthopedic surgeries.Keywords: pain, postsurgical; wound infiltration; local anesthetic; analgesi