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Набор скоро начнётся NCT06828601

Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury

Фаза IV С лечением Pain Management Burn Injury Lidocaine

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: IV Lidocaine, IV Saline.
Кому может быть актуально
Состояния в реестре: Pain Management, Burn Injury, Lidocaine. Базовые параметры: от 18 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury: A Pilot Study to Investigate Analgesic and Opioid Sparing Effects

Обзор

The purpose of this study is to find out if IV lidocaine infusion decreases the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use in burn injury participants undergoing wound debridement in the operating room. Participants will: * be randomized to receive either an IV Lidocaine treatment or an IV Saline Placebo during their surgery. The IV treatment continues for 48 hours after surgery. * be asked about their pain and how they're feeling at 4 timepoints during the 48 hours. * be asked about their pain 2 weeks after surgery. The participant and medical care providers will both be blinded to what IV treatment is being received. Researchers will compare the 2 groups to see if IV Lidocaine helps decrease the need of opioids, improves pain management, and reduces the risks of developing complications from prolonged opioid use (this includes opioid tolerance, opioid dependence, and opioid induced hyper-sensitivity to pain).

Вмешательства

  • Препарат IV Lidocaine
    Participant receives IV Lidocaine during surgery. Infusion continues for 48 hours. An initial bolus dose of 1.5 mg/kg ideal body weight (IBW) of IV study infusion will be given at the start of surgery, followed by infusion rate of 2.0 mg/kg/hr IBW intraoperatively.This will be reduced to 1.5 mg/kg/hr IBW postoperatively for 48 hours - once the patient has reached recovery.
  • Препарат IV Saline
    Participant receives IV Saline (placebo) during surgery. Infusion continues for 48 hours. An initial bolus dose of 1.5 mg/kg ideal body weight (IBW) of IV study infusion will be given at the start of surgery, followed by infusion rate of 2.0 mg/kg/hr IBW intraoperatively.This will be reduced to 1.5 mg/kg/hr IBW postoperatively for 48 hours - once the patient has reached recovery.

Первичные конечные точки

  • Feasibility of Study for future larger RCT-Recruitment [Срок оценки: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Preliminary Data [Срок оценки: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Acceptability of Intervention [Срок оценки: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Data collection [Срок оценки: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Reliability of data [Срок оценки: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Outcomes [Срок оценки: Through study completion, an average of 6 months]
  • Feasibility of Study for future larger RCT-Complete Data collection [Срок оценки: Through study completion, an average of 6 months]
Вторичные конечные точки (6)
  • Length of Hospital Stay [Срок оценки: Up to 50 weeks]
  • Adverse effects of lidocaine infusion [Срок оценки: 48 hours - During the lidocaine infusion]
  • Total MED [Срок оценки: MED assessed at 24-, 48-, and 72-hours post-operatively]
  • Pain Scores [Срок оценки: Scores assessed at 24-, 48-, and 72-hours post-operatively]
  • Quality of Recovery Scores [Срок оценки: Assessed 24-, 48-, and 72-hours post-operatively]
  • Brief Pain Inventory (Short Form) [Срок оценки: Assessed at 2 weeks post-operatively and at 3 months post-operatively]

Критерии участия

Критерии включения

  • Acute burn patients
  • 18 years or older
  • <20% Total Body Surface Area
  • Wound debridement surgery scheduled at Harborview Medical Center

Критерии исключения

  • History of polysubstance use
  • Chronic opioid use (MED>40mg for more than 6 weeks)
  • Cases where the known clinical standard care would be to keep patient intubated postoperatively
  • Cases where the known clinical standard care would avoid IV Lidocaine infusion
  • Allergy to amide local anesthetics
  • Any elevated risk for local anesthetic systemic toxicity as determined by the study team
  • Cardiac arrythmias or cardiovascular instability (e.g. shock)
  • Severe renal or hepatic impairment
  • Pregnancy
  • Local anesthesia will be given by another route (e.g. nerve block)
  • Prisoners
  • Non-English Speaking/reading

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06828601 · STUDY00018912

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗