Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

Официальное название

SMILe: Spinal Morphine or Intravenous Lidocaine in Robot-assisted Upper Urologic Surgery

Обзор

The goal of this clinical trial is to learn whether the addition of spinal analgesia leads to superior recovery in patients undergoing robotic-assisted laparoscopic upper urinary tract surgery under general anesthesia. The main questions it aims to answer are: * Is the decrease in wellbeing as quantified by the patient-centered outcome scale "Quality of Recovery 15" (QoR-15), from baseline to the first day after surgery (POD 1), at least 8.0 points less in patients receiving spinal analgesia in addition to general anesthesia? * Does spinal analgesia result in improved recovery as quantified by QoR-15 at POD 7, the incidence of postoperative pain at rest and at mobilization, nausea and vomiting, the need for opioid analgesics, time out-of-bed, length of stay and the incidence of complications? * Does spinal analgesia increase workload in the OR, as quantified by time from arrival in the OR to start of surgery? * Does spinal analgesia result in an increased incidence of hypotension and cardiac dysfunction during surgery, as well as an increased incidence of pruritus after surgery? Participants will be randomized to receive either spinal analgesia with bupivacaine and morphine preoperatively or an intravenous infusion with lidocaine intraoperatively. QoR-15 and other markers of recovery will be registered using structured interviews preoperatively, at POD1 and POD7. In addition, patients will record pain at rest and at mobilization three times daily in a diary. In a subgroup of patients advanced hemodynamic parameters will be recorded using pulse-contour analysis before, during and after surgery. Blood samples will also be collected in these patients at fixed intervals and analyzed for amongst others inflammation and cardiac dysfunction.

Подробное описание

Please refer to CTIS

Вмешательства

• Препарат spinal analgesia with morphine and bupivacaine
  single shot spinal analgesia with 0.2-0.3 mg morphine and 10-20 mg bupivacaine before surgery
• Препарат lidocaine infusion
  intraoperative intravenous infusion of lidocaine at a rate of 2 mg/kg/t after a bolus of 2 mg/kg (Ideal Body Weight if BMI \> 22, otherwise ABW)

Первичные конечные точки

• QoR-15 score at postoperative day 1 [Срок оценки: First day after surgery]

Вторичные конечные точки (12)

• QoR-15 score preoperatively [Срок оценки: Any time between inclusion and the night before surgery]
• QoR-15 score at postoperative day 7 [Срок оценки: Seventh day after surgery]
• Pain (NRS) in rest and during motion 2hrs after arrival to the PACU/ICU/HDU [Срок оценки: 2 hrs after arrival to the PACU]
• Pain (NRS) on POD 1-3 [Срок оценки: First, second and third day after surgery]
• Pain (NRS) in rest and during motion at POD 7 [Срок оценки: Seventh day after surgery]
• Time from arrival in the OR to start of surgery [Срок оценки: Time from entering the OR to first incision or start of endoscopy, whichever comes first, up to 4 hrs.]
• Time from end of surgery until leaving the OR [Срок оценки: Time from end of surgery (removing of surgical drapes or finishing of endoscopy, whichever comes last) until leaving the OR, up to 4 hrs]
• Incidence of unplanned termination of the lidocaine infusion [Срок оценки: Intraoperatively]
• Amount of remifentanil in patients given remifentanil [Срок оценки: Intraoperatively]
• Amount of intraoperative opioids in patients not receiving remifentanil [Срок оценки: Intraoperatively]
• Length of stay at the PACU/ICU/HDU [Срок оценки: Length of stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days]
• Amount of opioids administred at the PACU/ICU/HDU during the first 24 hrs after end of surgery [Срок оценки: During stay at the PACU (from first to final recording of any vital sign by the electronic patient data management system), up to 30 days]

Критерии участия

Критерии включения

• The patient is scheduled for elective robotic-assisted upper urinary tract surgery at one of the participating hospitals
• The patient gives oral and written informed consent after having received oral and writen information about the study

Критерии исключения

• The patient has a ASA-class of IV or above
• The patient is a minor or declared incompetent, has severe psychiatric disease or is expected not to be able to understand the study information due to severe restrictions in vision, hearing, cognition, reading or Swedish language abilities
• The patient is a female who is pregnant or breastfeeding
• The patient is a pre-menopausal female who has not undergone sterilisation, hysterectomy, bilateral salpingectomy and/or bilateral oophorectomy, and is not using highly-effective contraception with low user-dependency and cannot provide a negative pregnancy test
• The patient is scheduled for emergency surgery
• Research staff not available
• Scheduled significant simultaneous surgery on another organ
• The anesthesiologist in charge has planned spinal or epidural analgesia
• The patient has clear contraindications to spinal analgesia, e.g. severe coagulopathy, severe aortic stenosis, previous back surgery with rods, or spinal analgesia can be expected to be technically challenging (severe obesity, severe scoliosis)
• The patient has clear contraindications to lidocaine infusion, e.g. proven allergy to local anesthetics, myasthenia gravis, renail failure (eGFR < 30), hepatic failure caused by acute hepatitis or cirrhosis (Child-Pugh B or higher, severe cardiac arrythmias or insuffiency (NYHA IIIb or higher)
• The patient has previously participated in the trial

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

Лечение

Центры проведения

Швеция · 3 центра

• Länssjukhuset i Kalmar — Kalmar
• University Hospital Linköping — Linköping
• Centrallasarettet Växjö — Vaxjo

Публикации

• Holmberg M, Chew M, Nilsson L, Skoglund P, Bahlmann H. Rationale and design of the SMILe (Spinal Morphine or Intravenous Lidocaine) study: protocol for a multicentre randomised clinical trial in southern Sweden on whether spinal morphine improves postoperative recovery compared to intravenous lidocaine in patients undergoing robot-assisted upper urinary tract surgery. BMJ Open. 2026 May 6;16(5):e1 PMID 42091145

Идентификаторы

NCT: NCT06349668 · 2023-505941-21-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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