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Идёт набор NCT06434233

Opioid Use After Laparoscopic Salpingectomy

Фаза IV С лечением Opioid Use Post-operative Pain Sterility, Female

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: Acetaminophen, Ibuprofen, Oxycodone.
Кому может быть актуально
Состояния в реестре: Opioid Use, Post-operative Pain, Sterility, Female. Базовые параметры: от 18 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
США
Следующий шаг
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Официальное название

A Randomized Control Trial for Opioid Use After Laparoscopic Salpingectomy

Обзор

The purpose of this study is to evaluate patient-reported post-operative pain scores following minimally invasive tubal sterilization procedures to determine if a multimodal, non-opioid pain control regimen is non-inferior to a pain control regimen including opioids. The study team hypothesizes that with extensive counseling on pain management, multimodal medication use, and expectation with non-opioid methods can effectively eliminate the need for opioid prescriptions after laparoscopic salpingectomy.

Подробное описание

This study is designed as a non-inferiority trial comparing a non-opioid post-operative pain control regimen to the standard opioid pain control regimen for post-operative salpingectomy patients. A non-inferiority margin of 2 units was selected, such that the experimental treatment will be considered non-inferior if the lower bound of the confidence interval for the treatment difference remains above a 2 point difference in reported pain scores.

Вмешательства

  • Препарат Acetaminophen
    All patients will receive Acetaminophen 500 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Acetaminophen around the clock for the first 72 hours and as needed thereafter.
  • Препарат Ibuprofen
    All patients will receive Ibuprofen 600 mg orally every 6 hours scheduled x 30 tablets at post-operative discharge. All patients will be instructed to take Ibuprofen around the clock for the first 72 hours and as needed thereafter.
  • Препарат Oxycodone
    Patients randomized to Arm 1 will receive Oxycodone 5 mg orally every 4 hours as needed x 12 tablets at post-operative discharge Patients randomized to Arm 2 will not receive an Oxycodone prescription at post-operative discharge. However, participants will be informed that if they need additional pain medications, these will not be withheld. Participants in the second arm who require additional pain medications will receive the same amount of Oxycodone as in arm 1

Первичные конечные точки

  • Numeric post-operative pain score [Срок оценки: post-operative day 1 and post-operative day 7]
Вторичные конечные точки (5)
  • Satisfaction with post-operative pain relief [Срок оценки: post-operative day 1 and post-operative day 7]
  • Satisfaction with post-operative mobility [Срок оценки: post-operative day 1 and post-operative day 7]
  • Total narcotic consumption at one week post-operative [Срок оценки: post-operative day 7]
  • Occurrence of defined opioid related side effects (N/V, constipation, dizziness, itchiness) [Срок оценки: post-operative day 1 and post-operative day 7]
  • Suboptimal pain control as assessed by the number of patients requesting additional medication or seeking unplanned medical care for a post-surgical pain-related concern [Срок оценки: Within 30 days of surgery]

Критерии участия

Критерии включения

  • Individuals with a fallopian tube (unilateral and/or bilateral)
  • Age 18 years old and above
  • Undergoing minimally invasive (laparoscopic or robotic) unilateral or bilateral salpingectomy or other tubal sterilization procedure as the primary procedure
  • Benign indications for salpingectomy/tubal sterilization
  • Agreeing to participate

Критерии исключения

  • Chronic pain syndromes patients including fibromyalgia
  • Patients currently on long-term (i.e. for more than three months) opioid use
  • Conversion to laparotomy
  • Allergy or other contraindication to the prescribed medications such as acetaminophen or oxycodone
  • Salpingectomy that occurs in conjunction with a major Gyn surgery (i.e. hysterectomy, etc)
  • Salpingectomy performed for treatment of ectopic pregnancy
  • Patients with a history of gastritis and/or GI bleeding

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Johns Hopkins Bayview Medical Center — Baltimore

Идентификаторы

NCT: NCT06434233 · IRB00308549

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗