Multimodal Opioid-Sparing Analgesia for Post-Craniotomy Pain Management
Morphine versus multimodal analgesia for post elective craniotomy pain
Estudio de Tratamiento
Resumen
Fecha de inicio: 15 de diciembre de 2021
Fecha en la que se inscribió al primer participante.This study focuses on managing pain after a type of brain surgery called a craniotomy. The goal is to find a way to effectively reduce pain while using fewer opioids, which are strong painkillers that can have side effects like nausea, vomiting, and excessive sleepiness. The study involves people who have had elective craniotomies, which are planned surgeries to treat conditions like tumors or aneurysms. The importance of this research lies in the potential to improve recovery after brain surgery, reduce the need for opioids, and lower the risk of complications associated with their use. Participants in this study will receive either standard opioid painkillers or a combination of different types of pain-relieving medications known as 'multimodal analgesia'. This combination may include drugs like Paracetamol, NSAIDs, Gabapentin, and Dexmedetomidine, as well as a scalp block, which is a local anesthetic injected into the scalp. The study will compare the effectiveness of these two approaches in relieving pain, looking at factors such as the time until the first request for additional pain relief and the total amount of pain medication used. It will also monitor for any side effects, including nausea, vomiting, and excessive sleepiness.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 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.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 21 a 65 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.Criterios
Inclusion Criteria: \- 1. Patient consent. 2. Age : (21 to 65) years. 3. Sex : both. 4. ASA grade I-II (American society of anesthiologists). 5. Prepared to elective craniotomy under general anesthesia (for eg draining of Abscess, tumor, blood clot or aneurysm). 6\. Ability to take pills Exclusion Criteria: * 1\. Disturbed conscious level (Glascow coma score less than14). 2. Previous craniotomy. 3. Chronic use of analgesics or drug dependence or regular anticonvulsant, neuropathic or antidepressant use. 4\. Uncontrolled hypertension. 5. Extensive surgeries lasting more than 6 hours or patient needing postoperative ventilator support. 6\. Intracranial malformations. 7. Any complications during procedure such as massive intracranial hemorrhage. 8. Psychological disorder requiring pharmacologic treatment. 9. Regular systemic steroid use. 10. Renal impairment or liver dysfunction. 11. Allergy 12. Bleeding tendency
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 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
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