RESUMO
PURPOSE: Intravenous fluid management for deceased donor kidney transplantation is an important, modifiable risk factor for delayed graft function (DGF). The primary objective of this study was to determine if goal-directed fluid therapy using esophageal Doppler monitoring (EDM) to optimize stroke volume (SV) would alter the amount of fluid given. METHODS: This randomized, proof-of-concept trial enrolled 50 deceased donor renal transplant recipients. Data collected included patient characteristics, fluid administration, hemodynamics, and complications. The EDM was used to optimize SV in the EDM group. In the control group, fluid management followed the current standard of practice. The groups were compared for the primary outcome of total intraoperative fluid administered. RESULTS: There was no difference in the mean (standard deviation) volume of intraoperative fluid administered to the 24 control and 26 EDM patients [2,307 (750) mL vs 2,675 (842) mL, respectively; mean difference, 368 mL; 95% confidence interval (CI), - 87 to + 823; P = 0.11]. The incidence of complications in the control and EDM groups was similar (15/24 vs 17/26, respectively; P = 0.99), as was the incidence of delayed graft failure (8/24 vs 11/26, respectively; P = 0.36). CONCLUSIONS: Goal-directed fluid therapy did not alter the volume of fluid administered or the incidence of complications. This proof-of-concept trial provides needed data for conducting a larger trial to determine the influence of fluid therapy on the incidence in DGF in deceased donor kidney transplantation. TRIAL REGISTRATION: www.clinicaltrials.gov (NCT02512731). Registered 31 July 2015.
Assuntos
Débito Cardíaco , Hidratação/métodos , Transplante de Rim , Adulto , Idoso , Função Retardada do Enxerto/etiologia , Ecocardiografia , Ecocardiografia Doppler , Esôfago/diagnóstico por imagem , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Volume SistólicoRESUMO
BACKGROUND: Persistent pain is a common yet debilitating complication after breast cancer surgery. Given the pervasive effects of this pain disorder on the patient and healthcare system, post-mastectomy pain syndrome (PMPS) is becoming a larger population health problem, especially as the prognosis and survivorship of breast cancer increases. Interventions that prevent persistent pain after breast surgery are needed to improve the quality of life of breast cancer survivors. An intraoperative intravenous lidocaine infusion has emerged as a potential intervention to decrease the incidence of PMPS. We aim to determine the definitive effects of this intervention in patients undergoing breast cancer surgery. METHODS: PLAN will be a multicenter, parallel-group, blinded, 1:1 randomized, placebo-controlled trial of 1,602 patients undergoing breast cancer surgery. Adult patients scheduled for a lumpectomy or mastectomy will be randomized to receive an intravenous 2% lidocaine bolus of 1.5 mg/kg with induction of anesthesia, followed by a 2.0 mg/kg/h infusion until the end of surgery, or placebo solution (normal saline) at the same volume. The primary outcome will be the incidence of persistent pain at 3 months. Secondary outcomes include the incidence of pain and opioid consumption at 1 h, 1-3 days, and 12 months after surgery, as well as emotional, physical, and functional parameters, and cost-effectiveness. DISCUSSION: This trial aims to provide definitive evidence on an intervention that could potentially prevent persistent pain after breast cancer surgery. If this trial is successful, lidocaine infusion would be integrated as standard of care in breast cancer management. This inexpensive, widely available, and easily administered intervention has the potential to reduce pain and suffering in an already afflicted patient population, decrease the substantial costs of chronic pain management, potentially decrease opioid use, and improve the quality of life in patients. TRIAL REGISTRATION: This trial has been registered on clinicaltrials.gov (NCT04874038, Dr. James Khan. Date of registration: May 5, 2021).
Assuntos
Anestésicos Locais , Neoplasias da Mama , Lidocaína , Mastectomia , Estudos Multicêntricos como Assunto , Dor Pós-Operatória , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Lidocaína/administração & dosagem , Lidocaína/efeitos adversos , Neoplasias da Mama/cirurgia , Feminino , Dor Pós-Operatória/prevenção & controle , Dor Pós-Operatória/etiologia , Dor Pós-Operatória/diagnóstico , Mastectomia/efeitos adversos , Anestésicos Locais/administração & dosagem , Anestésicos Locais/efeitos adversos , Infusões Intravenosas , Resultado do Tratamento , Medição da Dor , Qualidade de Vida , Dor Crônica/prevenção & controle , Dor Crônica/etiologia , Mastectomia Segmentar/efeitos adversos , Fatores de Tempo , Analgésicos Opioides/administração & dosagem , Analgésicos Opioides/uso terapêutico , Analgésicos Opioides/efeitos adversos , Análise Custo-BenefícioRESUMO
BACKGROUND: The study aims were to model acute pain intensity and opioid consumption trajectories up to 72 hr after open hepatic resection, identify predictors of trajectory membership and examine the association between trajectory memberships and 6-month pain and psychological outcomes. This is a long-term analysis of a published randomized controlled trial on the impact of medial open transversus abdominis plane catheters on post-operative outcomes. METHODS: A total of 152 patients (89 males; mean age 63.0 [range: 54-72]) completed questionnaires on pain and related characteristics pre-operatively and 6 months post-operatively. Total opioid use was recorded several times over a 72-hr period while self-reported pain intensity scores were collected multiple times until hospital discharge. Analyses were carried out using growth mixture modelling, logistic regression and general linear models. RESULTS: Both pain intensity and opioid consumption showed that a four-trajectory model best fits the data. Patients in the lowest opioid consumption trajectory were more likely to be classified in the constant mild pain intensity trajectory. Age and baseline levels of anxiety significantly predicted opioid trajectory membership while baseline depressive symptoms significantly predicted pain intensity trajectory membership. Patients in the two highest opioid consumption trajectories reported significantly higher levels of pain catastrophizing at 6 months compared to patients in the other 3 trajectories (all p < 0.05). CONCLUSION: High consumption of opioids after surgery is associated with higher levels of pain catastrophizing 6 months later. Identification of patients within these trajectories may lead to the development of early interventions targeted to high risk individuals. SIGNIFICANCE: Differences in initial levels of opioid consumption and rates of change in opioid consumption shortly after surgery can help predict long-term psychological responses to pain. Identifying key characteristics associated with initial opioid consumption can lead to the development of cost-effective early interventions targeted to high risk individuals.