Acupuncture Randomized Trial for Post Anaesthetic Recovery and Postoperative Pain - a Pilot Study
Acupuncture Regimen
+ Acupressure Regimen
Manifestaciones Neurológicas+4
+ Dolor
+ Procesos Patológicos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de junio de 2012
Fecha en la que se inscribió al primer participante.The use of complementary approaches, especially acupuncture, has gained momentum within the last decade. In this regard, it might be appropriate to develop a simply applicable (a) and effective (b) acupuncture regimen for the complementary support of fast-track anaesthesia. Regarding practicability (a), it might be of interest to reduce the amount of necessary acupuncture points. Trials have shown that single-point acupuncture is strong enough to cause relevant clinical effects (Fleckenstein et al., 2009; Lee and Fan, 2009). In addition, practicability means to reduce the amount of needling events; therefore the investigators suggest the use of press needles, making complete peri-anaesthetic availability possible. Regarding effectiveness (b), it has been reported that acupuncture at Governing Vessel 26 (Du-26) may be successful in shock resuscitation (Hsu et al., 2006). In combination with other points it has been evaluated in a Chinese study improving the vegetative state after operation of acute subdural hematoma (Zheng, 2005).
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 75 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Age 18+ Scheduled for laparoscopic surgery of uterus, adnex or ovaries ASA-score ≤ 2 Subjects with the ability to follow study instructions and likely to attend and complete all required visits Written informed consent of the subject Exclusion Criteria: General Exclusion Criteria: Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial Simultaneously participation in another clinical trial or participation in any clinical trial involving administration of acupuncture within 30 days prior to clinical trial beginning Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial Known or persistent abuse of medication, drugs or alcohol Exclusion criteria regarding special restrictions for females: Current or planned pregnancy or nursing women Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases. Indication specific exclusion criteria: Subjects will not be included in the study if any of the following criteria applies: Surgery within the last three months Chronic pain > 3 month Continuous analgesic medication with opioids longer than 3 days Massive degenerative diseases Pre-treatment with acupuncture or trigger point injection within the last 2 months
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.3 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Comparador ActivoGrupo II
Sin IntervenciónGrupo III
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Department of Anaesthesiology, University of Munich, Germany.
Munich, GermanyAbrir Department of Anaesthesiology, University of Munich, Germany. en Google Maps