NCT07133048已完成不适用
Evaluation of Regional Blocks Efficacy in Orthognathic Surgery
Clinical Hospital Center Rijeka1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年3月2日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The amount of analgesics given after surgery
研究概览
简要总结
The proposed study, which will be carried out on 72 male and female patients, who have reached bone maturity, are younger than 50 years and underwent orthognathic surgical procedures. Patients will be divided into a study group which will receive a regional block with levobupivacaine and a control group that will receive saline as a placebo. The main hypothesis is that regional analgesia in orthognathic surgery contributes to intraoperative and postoperative analgesia. The aim is to determine the real benefit of regional analgesia in orthognathic surgery and analyze the impact of psychosocial factors on results. Various psychological questionnaires, pain scale and questionnaires for evaluation of postoperative recovery will be used in the research. The results of the research could contribute to a better understanding of regional anesthesia in orthognathic surgery and determine impact of psychosocial factors on pain level and satisfaction with orthognathic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bone deformities for which one of the following surgical procedures is performed: bimaxillary osteotomy, bimaxillary osteotomy with genioplasty, isolated Le Fort I osteotomy, or isolated sagittal osteotomy of the mandible
- •patients who have reached skeletal maturity and are under 50 years of age
- •patient classified as ASA I and ASA II (American Society of Anesthesiologists).
排除标准
- •known allergy to local anesthetics
- •refusal to participate in the study
- •patients with a cleft of the primary and/or secondary palate
- •patients with craniofacial syndromes
- •patients who have undergone surgical revision for any reason
结局指标
主要结局
The amount of analgesics given after surgery
时间窗: In the first 24 hours after surgery
The amount of analgesics given after surgery will be measured; patients who have more severe pain will request more analgesics
次要结局
- How mental status (catastrophizing) affects the amount of analgesics taken(The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.)
- How mental status (hypervigilance) affects the amount of analgesics taken(The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.)
- How mental status (anxiety) affects the pain level(The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.)
- How mental status (catastrophizing) affects postoperative nausea and vomiting(The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.)
- Influence of the block on postoperative pain levels(At 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.)
- How mental status (somatosensory amplification) affects the amount of analgesics taken(The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery.)
- How mental status (anxiety) affects the amount of analgesics taken(The day before surgery participants completed Croatian version of all psychological questionnaires. Analgesics given in the first 24 hours after surgery)
- How mental status (catastrophizing) affects the pain level.(The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.)
- Influence of the level of pain expressed on the VAS scale to the Quality of Life(VAS scale at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery. SF-36 second days after the surgical procedure and at discharge day)
- How mental status (hypervigilance) affects the Quality of Life(The day before surgery participants completed Croatian version of psychological questionnaires(BHS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed SF-36.)
- How mental status (somatosensory amplification) affects the Quality of Life(The day before surgery participants completed Croatian version of psychological questionnaires(SSAS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed SF-36.)
- How mental status (hypervigilance) affects the pain level.(The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.)
- How mental status (somatosensory amplification) affects the pain level(The day before surgery participants completed Croatian version of all psychological questionnaires. Pain level at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery.)
- How block affect on postoperative nausea and vomiting(On the first postoperative day, participants completed the PONV questionnaire.)
- How mental status (anxiety) affects postoperative nausea and vomiting(The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.)
- How mental status (hypervigilance) affects postoperative nausea and vomiting(The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.)
- How mental status affects (somatosensory amplification) postoperative nausea and vomiting(The day before surgery participants completed Croatian version of all psychological questionnaires. On the first postoperative day, participants completed the PONV questionnaire.)
- Influence of the block on the Quality of Life(2 days after the surgical procedure and at discharge day)
- How mental status (catastrophizing) affects the Quality of Life(The day before surgery participants completed Croatian version of psychological questionnaires. SF-36 second days after the surgical procedure and at discharge day.)
- How mental status (anxiety) affects the Quality of Life(The day before surgery participants completed Croatian version of psychological questionnaires(GAD7). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure)participants completed SF-36.)
- Influence of the block on the Quality of Recovery(The first day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed Croatian version of QoR-40 questionnaire.)
- Influence of the block on the satisfaction with the surgical procedure(Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.)
- Influence of the level of pain expressed on the VAS scale to the Quality of Recovery (QoR-40)(VAS scale at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery. Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.)
- How mental status (catastrophizing) affects the Quality of Recovery(The day before surgery participants completed Croatian version of psychological questionnaire (PCS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.)
- How mental status (hypervigilance) affects the Quality of Recovery(The day before surgery participants completed Croatian version of all psychological questionnaires (BHS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.)
- How mental status (somatosensory amplification) affects the Quality of Recovery(The day before surgery participants completed Croatian version of psychological questionnaires (SSAS). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.)
- How mental status (anxiety) affects the Quality of Recovery(The day before surgery participants completed Croatian version of psychological questionnaires (GAD7). Second day after the surgical procedure and at discharge day (an average of third day after surgical procedure) participants completed QoR-40.)
- Influence of the level of pain expressed on the VAS scale to the satisfaction with the surgical procedure(VAS scale at 1 hour, 3 hours, 5 hours, 7 hours, 9 hours, 12 hours, and 24 hours after the end of the surgery. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.)
- How mental status (catastrophizing) affects the satisfaction with the surgical procedure(The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.)
- How mental status (hypervigilance) affects the satisfaction with the surgical procedure(The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.)
- How mental status (somatosensory amplification) affects the satisfaction with the surgical procedure(The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.)
- How mental status (anxiety) affects the satisfaction with the surgical procedure(The day before surgery participants completed Croatian version of psychological questionnaires. Two months after the surgical procedure, the patient completed the SSQ-8 questionnaire.)
研究者
David Harmicar
Principal Investigator
Clinical Hospital Center Rijeka
研究点 (1)
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