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Набор скоро начнётся NCT05450055

Intraperitoneal Lidocaine in Ovarian Cancer Surgery

Без фазы С лечением Ovarian Cancer Post Operative Pain

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: intraperitoneal lidocaine analgesic or normal saline as control.
Кому может быть актуально
Состояния в реестре: Ovarian Cancer, Post Operative Pain. Базовые параметры: 18 лет — 75 лет · Женщины.
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
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Официальное название

A Randomized Controlled Trial to Investigate Effect of Postoperative Intraperitoneal Lidocaine on the Analgesic and Prognosis of Patients With Ovarian Cancer

Обзор

The main objective of this trial is to improve the postoperative analgesia effect and prognosis of patients with ovarian cancer after laparotomy surgery. This is a randomized, double-blind, controlled trial to evaluate analgesia and patient outcomes after local peritoneal anesthesia after surgery.

Подробное описание

This is a prospective, randomized, controlled clinical study. Sixty patients were expected to participate in a centralized randomized study method divided into two groups of 30 patients per group: the intraperitoneal analgesic group and the normal saline control group. Standard routine anesthesia was performed in both groups using the same method, and intravenous analgesia pump was routinely used in clinical use after surgery. The intraperitoneal analgesic group was continuously pumped with local anesthetics into the abdominal cavity, while the control group was pumped with normal saline. Visual analogue pain score (VAS), amount of remedial analgesia and use of analgesia pump were recorded at 1, 2, 4, 8, 12, 24, 36, 48, 60 and 72 hours after operation. Record the time when the patient began drinking and eating, and the time when gastrointestinal function (defecation or exhaust) recovered. The time of starting to walk on the ground (including the time of needing attendant assistance or not) and the time of meeting the standard of postoperative discharge preparation. Perioperative peripheral blood samples were collected for five times (T0 before anesthesia induction, T1 after tracheal extubation, T2 on the morning of the first postoperative day, T3 on the morning of the second postoperative day, and T4 on the morning of the third postoperative day), and inflammatory factors and tumor-related indicators were monitored. Adverse reactions were recorded. The prognosis of the patients was followed up 5 years after operation.

Вмешательства

  • Процедура intraperitoneal lidocaine analgesic or normal saline as control
    Before the end of surgery, patients in the experimental group (L group) were extensively sprayed with 20mL (100mg) 0.5% lidocaine intraperitoneally before the peritoneum was sutured. The surgeon placed intraperitoneal catheter with the catheter tip above the vaginal end while placing percutaneous drainage tube. The intraperitoneal catheter was connected to the electronic analgesia pump, and the infusion of 0.5% lidocaine 10mL/h was interrupted from 1 to 72h after surgery, with a total volume of

Первичные конечные точки

  • Postoperative analgesic use [Срок оценки: Postoperative 72 hours]
Вторичные конечные точки (4)
  • Survival time (months) [Срок оценки: Postoperative 5 years]
  • Disease free survival time (months) [Срок оценки: Postoperative 5 years]
  • Recurrence (yes/no, if yes ,record recurrence date) [Срок оценки: Postoperative 5 years]
  • Postoperitive chronic pain duration (months) [Срок оценки: Postoperative 5 years]

Критерии участия

Критерии включения

  • The American Society of Anesthesiologists (ASA) rated them as grade I to II, aged 18 to 75 years.
  • Patients undergoing elective laparotomy for ovarian cancer reduction (surgical resection includes the whole uterus with or without double adnexa, lymph node biopsy, dissection, appendectomy, etc.).

Критерии исключения

  • Suffering from mental illness or unable to cooperate with pain and related index scoring, unable to use automatic pump.
  • Peritoneal infection existed before surgery
  • Past history of arrhythmia
  • Severe liver and kidney dysfunction existed before surgery
  • Known allergy to local anesthetics
  • Do not agree to participate in the research

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT05450055 · M2021589

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗