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1.
Eur J Orthop Surg Traumatol ; 28(4): 667-675, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29264786

RESUMO

BACKGROUND: Postoperative pain is one of the issues that concern most patients after total knee arthroplasty (TKA). Periarticular multimodal drug injection and single anesthetic agent injection have been shown to effectively reduce postoperative pain. The purpose of this study was to compare the efficacy between multimodal drug injection and single anesthetic drug injection in controlling pain after TKA using a double-blinded randomized controlled trial. METHODS: Sixty-four osteoarthritic patients who underwent primary TKA were randomized into two groups. The multimodal drug injection group (group M) received levobupivacaine 150 mg, ketorolac 30 mg and morphine 5 mg, while the single anesthetic drug injection group (group S) received only levobupivacaine 150 mg. The primary outcomes were pain level (VAS), quantity of opioid consumption (mg) and time to request the first dose of analgesic drug (min). RESULTS: Multimodal drug injection provided lower pain level in the first 4 h after surgery (VAS rest: 30 vs 46, p = 0.02; VAS motion: 45 vs 66, p = 0.03). They consumed less morphine mostly in the first 8 h after surgery (5 vs 12 mg, p < 0.0001) and had approximately 2 h longer time to request the first dose of analgesic drug (254 vs 148 min, p = 0.02). CONCLUSIONS: Multimodal drug injection decreases pain level, reduces morphine consumption in the early postoperative period and prolongs the analgesic effect compared to single anesthetic drug. One may consider using single anesthetic agent only in patients who have high risk of opioid or NSAIDs side effect.


Assuntos
Anestésicos Combinados/administração & dosagem , Artroplastia do Joelho/métodos , Dor Pós-Operatória/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Analgésicos Opioides/administração & dosagem , Bupivacaína/administração & dosagem , Bupivacaína/análogos & derivados , Método Duplo-Cego , Feminino , Humanos , Injeções Intra-Articulares , Cetorolaco/administração & dosagem , Tempo de Internação , Levobupivacaína , Masculino , Pessoa de Meia-Idade , Morfina/administração & dosagem , Osteoartrite do Joelho/cirurgia , Medição da Dor , Resultado do Tratamento
2.
Eur J Clin Pharmacol ; 73(2): 141-149, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-27838760

RESUMO

PURPOSE: This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS: A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS: The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS: The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.


Assuntos
Compreensão , Termos de Consentimento , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Pesquisa Biomédica , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Educação de Pacientes como Assunto , Inquéritos e Questionários , Tailândia , Adulto Jovem
3.
Clin Orthop Relat Res ; 471(6): 1992-9, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23397315

RESUMO

BACKGROUND: Postoperative pain after TKA is a major concern to patients. The best technique to control pain is still controversial. Intrathecal morphine or periarticular multimodal drug injection are both commonly used and both appear to provide better pain control than placebo, but it is unclear whether one or the other provides better pain control. QUESTIONS/PURPOSES: We asked whether intrathecal morphine or periarticular multimodal drug injection provides better pain control with fewer adverse events. METHODS: In a prospective, double-blind, randomized controlled trial we randomized 57 patients with osteoarthritic knees who underwent TKAs into two groups. Group M (n = 28) received 0.2 mg intrathecal morphine while Group I (n = 29) received periarticular multimodal drug injection. Postoperative pain was managed with patient-controlled analgesia using ketorolac. The outcomes were pain levels, the amount of analgesic drug used, and drug-related side effects. Patients and evaluators were blinded. All patients were followed up to 3 months. RESULTS: We found no difference in postoperative pain level, analgesia drug consumption, blood loss in drain, and knee function. More patients in Group M required antiemetic (19 [69%] versus 10 [34%]) and antipruritic drugs (10 [36%] versus three [10%]) than patients in Group I. CONCLUSIONS: The two techniques provide no different pain control capacity. The periarticular multimodal drug injection was associated with lower rates of vomiting and pruritus.


Assuntos
Analgésicos Opioides/uso terapêutico , Artroplastia do Joelho/efeitos adversos , Morfina/uso terapêutico , Manejo da Dor/métodos , Dor Pós-Operatória/tratamento farmacológico , Idoso , Analgésicos Opioides/administração & dosagem , Anti-Inflamatórios não Esteroides/uso terapêutico , Antieméticos/uso terapêutico , Antipruriginosos/uso terapêutico , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Injeções Intra-Articulares , Injeções Espinhais , Cetorolaco/uso terapêutico , Masculino , Morfina/administração & dosagem , Dor Pós-Operatória/fisiopatologia , Estudos Prospectivos , Prurido/complicações , Prurido/tratamento farmacológico , Resultado do Tratamento , Vômito/complicações , Vômito/tratamento farmacológico
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