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临床试验/NCT07252817
NCT07252817已完成不适用

Seguimiento Intensivo Del Dolor Postoperatorio en cirugía Mayor Ambulatoria: Estudio de Viabilidad y Resultados

Consorci Sanitari del Maresme2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2025年2月17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
280
试验地点
2
主要终点
Quality of Recovery

研究概览

简要总结

Moderate to severe acute postoperative pain (APP) during part of the postoperative period is a barrier that hinders the central objective of perioperative medicine, which is to achieve an optimal postoperative recovery process. Despite advances in perioperative medicine, a large proportion of post-operative patients continue to suffer from moderate to severe APS during many of the days of their convalescence. This poor control of APS, in addition to causing suffering and exposing the patient to an increased risk of complications, could impair the quality of post-surgical recovery , according to some authors. We therefore consider it to be of utmost interest in our field to corroborate whether the implementation of measures to better control DAP is related to a better quality of post-surgical recovery.

Currently, the growing trend to take into account the perspective of patients in their care has prompted the development of various patient-centred measurement tools that, among other aspects, assess the quality of post-surgical recovery. Several scales have been designed. The most widely used are the QoR-40, QoR-9 and QoR-15 scales. The latter, with a range of 0 to 150, was developed to simplify assessment, especially in telephone follow-ups, and has a reliability similar to its predecessor, the QoR-40.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ≥ 18 years old.
  • ASA I - III.
  • Scheduled for the surgeries: Laparoscopic or open inguinal hernia repairs, Laparoscopic cholecystectomies, Haemorrhoid surgeries, Knee arthroscopies, Shoulder arthroscopies.
  • Willingness to be contacted by telephone during the duration of the study.
  • Informed written consent to participate in this study.

排除标准

  • Lack of proficiency in Spanish.
  • Undergoing study or follow-up for moderate to severe cognitive impairment.
  • Pregnant or breastfeeding patients.
  • Patients on major opioid medication.
  • Patients with a history of dependence/abuse of alcohol or illicit drugs at present.
  • Patients under active follow-up by the chronic pain unit.

结局指标

主要结局

Quality of Recovery

时间窗: Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery

Quality of Recovery (QoR15 test)

次要结局

  • Satisfaction of pain control(Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery)
  • Adherence to prescribed analgesic treatment(Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery)
  • Pain Control by Visual Analogic Scale(Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery)
  • Satisfaction of pain control(Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery)
  • Adherence to prescribed analgesic treatment(Baseline (pre-surgery) and 48 hours, 7 days and 14 days post-surgery)

研究者

发起方
Consorci Sanitari del Maresme
申办方类型
Other
责任方
Sponsor

研究点 (2)

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