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Набор скоро начнётся NCT07183345

Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids

Ранняя фаза I С лечением Incarcerated Mixed Hemorrhoids

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dynamic Pain Assessment and Management System, Routine drug analgesia.
Кому может быть актуально
Состояния в реестре: Incarcerated Mixed Hemorrhoids. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial

Обзор

This study aims to investigate whether the dynamic pain assessment and management system can alleviate postoperative pain in patients with incarcerated mixed hemorrhoids and reduce the incidence of complications. A total of 64 eligible patients were enrolled and randomly divided into two groups, with the specific grouping and intervention methods as follows: ① Control Group: Routine drug analgesia and conventional nursing education were adopted. ② Study Group: Patients were managed with the dynamic pain assessment and management system, which included preoperative administration of analgesic drugs, postoperative traditional Chinese medicine (TCM) fumigation, wrist-ankle acupuncture for pain relief, and personalized nursing education. The study evaluated the effect of the dynamic pain assessment and management system on postoperative analgesia by comparing the Numerical Rating Scale (NRS) scores for pain, recording the Visual Analogue Scale (VAS) scores for quality of life, and analyzing the incidence of complications among patients in different groups. The primary hypothesis of the study is that, compared with routine pain management methods, the dynamic pain assessment and management system can significantly reduce postoperative pain in patients, improve their quality of life, and decrease the incidence of complications (such as bleeding and urinary retention).

Вмешательства

  • Другое Dynamic Pain Assessment and Management System
    Personalized nursing education was adopted. These measures include the use of preoperative analgesic drugs, postoperative Traditional Chinese Medicine (TCM) fumigation, and wrist-ankle acupuncture for pain relief.
  • Препарат Routine drug analgesia
    adopted routine drug analgesia and conventional nursing education

Первичные конечные точки

  • Pain Numerical Rating Scale (NRS) [Срок оценки: Baseline, Day 1, 3, 5, 7, and Day 14±2]
Вторичные конечные точки (2)
  • Incidence Rate of Complications [Срок оценки: within 30 days after surgery]
  • Length of Hospital Stay [Срок оценки: from the end of surgery to discharge (a maximum of 7 days)]

Критерии участия

Критерии включения

  • Aged between 18 and 75 years old
  • Diagnosed with grade III-IV incarcerated mixed hemorrhoids according to the Goligher classification
  • Undergoing standard hemorrhoidectomy
  • Receiving simple intraspinal anesthesia

Критерии исключения

  • Pregnant or lactating patients
  • Patients receiving immunotherapy or with coagulation dysfunction
  • Patients who need to use various analgesic drugs daily
  • Complicated with other anorectal diseases (such as perianal abscess, anal fistula, anal incontinence)
  • Complicated with other systemic diseases (cardiac insufficiency; hepatic or renal insufficiency; diabetes mellitus; coagulation disorders; peptic ulcer, etc.)
  • Incomplete perioperative clinical data
  • Unable to cooperate with follow-up

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Китай · 1 центр
  • Affiliated Hospital of Putian University — Putian

Идентификаторы

NCT: NCT07183345 · putianU-006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗