Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy

Официальное название

Analgesic Efficacy of an Opioid-free Postoperative Pain Management Strategy Versus a Conventional Opioid-based Strategy Following Video-assisted Thoracoscopic Lobectomy: an Open-label, Randomized, Controlled, Non-inferiority Trial

Обзор

Investigators have designed a randomized controlled trial. Utilizing an open-label, randomized, controlled study methodology, this trial aims to explore a opioid-free, safe, and effective analgesic approach for thoracic surgery. It also seeks to provide clinical guidance for the implementation of opioid-free or reduced-opioid postoperative analgesia in other thoracic procedures, aiming to optimize postoperative pain management for patients and ultimately enhance the overall patients recovery experience.

Подробное описание

Patients who undergo thoracoscopic lobectomy are often at an elevated risk of opioid-related complications due to their reliance on opioids. This overdependence not only decelerates the postoperative recovery process but also significantly increases healthcare costs. Although there is a surge of interest in opioid-free anesthetic analgesia (OFA) for its potential to reduce adverse outcomes associated with opioid use, there is a dearth of randomized controlled trials examining the efficacy of postoperative analgesia in patients undergoing thoracoscopic surgery. Consequently, the actual effectiveness of OFA in improving postoperative pulmonary complications and facilitating patient recovery remains unclear. Its application is still in the exploratory phase, with clinical practice lacking definitive guidelines to endorse or discard OFA as an alternative for postoperative analgesia in thoracoscopic surgery.

To bridge this knowledge gap and evaluate the perioperative analgesic efficacy of OFA compared to traditionally used opioids in selected cancer patients undergoing thoracoscopic surgery, investigators have designed a randomized controlled trial. Utilizing an open-label, randomized, controlled study methodology, this trial aims to explore a opioid-free, safe, and effective analgesic approach for thoracic surgery. It also seeks to provide clinical guidance for the implementation of opioid-free or reduced-opioid postoperative analgesia in other thoracic procedures, aiming to optimize postoperative pain management for patients and ultimately enhance the overall patient recovery experience.

Вмешательства

• Препарат Ropivacaine
  300 mL of 0.25% ropivacaine, the mode was intermittent pumping, and the parameters were set as follows: 30 mL of the first dose, 5 mL/h of the background dose, and 10 mL of the pumping every 6h for the first 24 hours after the operation.
• Препарат Sufentanil
  Sufentanil 2.0 μg/kg, 0.9% saline diluted to 100 mL, background dose of 2 ml/h, no loading dose, activated after extubation and continued until 48 hours postoperatively.

Первичные конечные точки

• Postoperative 48-h analgesic efficacy at cough [Срок оценки: Leave the PACU (T0), postoperative 6 hours (T1)、postoperative 12 hours (T2)、 postoperative 24 hours (T3)、 postoperative 36 hours (T4) and postoperative 48 hours (T5).]

Вторичные конечные точки (10)

• Postoperative 48-h analgesic efficacy at rest [Срок оценки: Leave the PACU, postoperative 6 hours、postoperative 12 hours、 postoperative 24 hours、 postoperative 36 hours and postoperative 48 hours .]
• Postoperative quality of recovery [Срок оценки: Postoperative 24 hours 、postoperative 48 hours]
• Postoperative pulmonary complications [Срок оценки: From the time of leaving the PACU until the time of the first occurrence of pulmonary complications or the time of death from any cause, whichever came first, assessed up to 30 days.]
• The 48-hour postoperative rescue analgesia rate [Срок оценки: First 48 hours postoperatively]
• Postoperative analgesic failure [Срок оценки: First 48 hours postoperatively]
• Patient satisfaction with postoperative pain ratings [Срок оценки: First 48 hours postoperatively]
• Time to resume [Срок оценки: From the time of leaving the PACU until the time to off-bed, bowel movement, and oral intake or the time of death from any cause, whichever came first, assessed up to 7 days.]
• The incidence of unplanned ICU admission and reoperation [Срок оценки: From the time of leaving the PACU until the time to unplanned ICU admission or reoperation or the time of death from any cause, whichever came first, assessed up to 30 days.]
• The 30d- and 90d- mortality [Срок оценки: Of the time from leaving the PACU to the time of postoperative 90day.]
• Related Adverse Events [Срок оценки: First 48 hours postoperatively]

Критерии участия

Критерии включения

• Aged between 18 and 65 years.
• Patients with lung cancer or suspected lung cancer who are undergoing lobectomy surgery via Video-assisted thoracoscopic surgery (VATS) or Robotic-assisted thoracoscopic surgery (RATS).
• American anesthesiologist association (ASA) physical status classificationⅠ-Ⅲ.
• Surgery is expected to last at least 2 hours, with a minimum of 2 days of postoperative hospitalization.
• Patients participate voluntarily and have signed an informed consent form.

Критерии исключения

• Patients who underwent open-heart surgery.
• Patients with BMI ≥30 kg/m², or ≤18.5 kg/m².
• Patients who are allergic to any of the local anesthetic drugs, such as ropivacaine, lidocaine, bupivacaine, procaine, bupivacaine, benzocaine, dacronin, etc.
• Patients who are allergic to any of the general anesthesia drugs, such as those including propofol, sufentanil, remifentanil, etc.
• Patients who currently have active ulcers or have gastrointestinal bleeding or who are allergic to any NSAIDs such as parecoxib sodium, flurbiprofenol ester, and acetaminophen.
• Patients with contraindications to epidural spinal plane block (ESPB), such as skin infection near the puncture site or coagulation disorders.
• Patients allergic to ultrasound gel.
• Patients with significant preoperative renal insufficiency (creatinine more than twice the upper limit of normal).
• Patients with severe spinal deformities prior to surgery.
• Patients with preoperative distant tumor metastasis.
• Patients who have experienced cardiovascular or cerebrovascular accidents within the past six months.
• Patients with unstable angina, ischemic myocardial infarction, or heart failure in the last six months.
• Patients with severe preoperative lung disease (such as pulmonary fibrosis, severe lung abscess, pulmonary heart disease; or with FEV1 less than 50% of the predicted value, PaO2 ≤ 60 mmHg, PaCO2 > 50 mmHg).
• Patients with poorly controlled preoperative hypertension or diabetes mellitus.
• Patients with a past history of dementia, psychosis, or other neurological disorders.
• Patients undergoing concurrent treatment for other surgical conditions.
• Patients taking sedatives, antidepressants, or hormonal medications.
• Patients with chronic pain, alcoholism, or drug dependence.
• Patients who are pregnant or breastfeeding
• Patients with other potentially serious medical conditions.
• Patients who are unable to understand Mandarin or Cantonese.
• Patients who participated in other clinical trials in the past 3 months
• Patients who refuse to participate in the study or sign the informed consent form.

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

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06570538 · ATHGuangzhou.

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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