- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07631091
Post-Operative Spinal Block Duration and Pain Relief After Hip Replacement Surgery: Comparing Single-Shot Spinal Ropivacaine and Bupivacaine (ROBUTHA)
Post-Operative Analgesia and Spinal Block Duration Following Total Hip Arthroplasties: Comparison of Single-Shot Intrathecal Ropivacaine and Bupivacaine in a Randomized Double-Blinded Controlled Study
Обзор исследования
Статус
Условия
Подробное описание
Patients undergoing outpatient total hip arthroplasty (THA) under spinal anesthesia require an anesthetic technique that provides adequate surgical anesthesia while allowing rapid postoperative recovery and same-day discharge. Bupivacaine is currently the most commonly used spinal anesthetic for hip arthroplasty, but its relatively long duration of action may delay recovery of motor and sensory function, prolong post-anesthesia care unit (PACU) stay, and increase the risk of urinary retention. Ropivacaine is a long-acting amide-type local anesthetic with a shorter duration of action and a potentially more favorable safety profile, including lower cardiotoxicity and reduced hemodynamic effects. This study aims to determine whether isobaric ropivacaine is more suitable than isobaric bupivacaine for spinal anesthesia in outpatient THA and to identify the optimal dose of ropivacaine for this surgical setting.
Altogether 176 patients scheduled for elective outpatient unilateral total hip arthroplasty at TYKS ORTO Surgical Hospital will be enrolled in this prospective, randomized, double-blind, controlled phase IV clinical trial. Eligible participants will be between 18 and 80 years of age, with a height of 160-186 cm, ASA physical status I-II, and body mass index below 35 kg/m², in accordance with local outpatient surgery criteria. Written informed consent will be obtained from all participants prior to study inclusion.
Patients will be randomized into two study groups to receive either intrathecal isobaric ropivacaine or intrathecal isobaric bupivacaine for spinal anesthesia. Both participants and investigators will remain blinded to group allocation throughout the study period. Spinal anesthesia will be performed according to standard clinical practice. Patient monitoring and perioperative care will follow institutional protocols routinely used for outpatient joint replacement surgery.
Baseline measurements including heart rate, blood pressure, and oxygen saturation will be recorded before administration of spinal anesthesia. After intrathecal injection, patients will undergo continuous monitoring including blood pressure, pulse, electrocardiography (ECG), oxygen saturation, and assessment of sensory block height. Measurements will initially be recorded every five minutes during the intraoperative period and subsequently at longer intervals after transfer to the ward.
The primary outcome of the study is the time to full recovery of sensory and motor function following spinal anesthesia. Secondary outcome measures include the proportion of patients discharged home as planned on the day of surgery, duration of PACU stay and total hospital stay, postoperative pain intensity measured using the Numerical Rating Scale (NRS; minimum 0, maximum 10, higher scores indicating more severe pain), incidence of urinary retention, time required to achieve adequate surgical anesthesia, adequacy of anesthesia during surgery, incidence of postoperative nausea and vomiting (PONV), postoperative opioid consumption, and patient satisfaction with care and recovery.
Postoperative pain management will follow standard institutional protocols. Pain intensity will be assessed regularly in the PACU and surgical ward using the NRS scale. Additional postoperative opioid analgesics may be administered as clinically indicated. Follow-up telephone interviews will be conducted on postoperative days 2 and 3 to assess recovery at home, pain management, discharge-related challenges, and patient satisfaction.
Bupivacaine and ropivacaine are both widely used amide-type local anesthetics for spinal anesthesia in orthopedic surgery. Their mechanism of action is based on reversible blockade of sodium channels in nerve cells, thereby inhibiting nerve impulse conduction. Ropivacaine has been associated with less cardiotoxicity, reduced central nervous system toxicity, and shorter duration of motor blockade compared with bupivacaine, which may improve suitability for outpatient surgery.
Both study medications are routinely used in clinical practice at TYKS ORTO Surgical Hospital and throughout the Nordic countries. Serious adverse effects are rare and are typically associated with overdose or unintentional intravascular administration. Common effects related to spinal anesthesia include transient hypotension due to sympathetic blockade, urinary retention, post-spinal headache, and temporary back pain. Severe complications such as infection or nerve injury are extremely uncommon. The study specifically aims to evaluate whether shorter-duration spinal anesthesia may reduce delayed recovery and urinary retention while maintaining adequate surgical conditions and postoperative analgesia.
All participant data will be handled confidentially. Personal identifiers will be removed from study documents and replaced with study identification numbers. The code key linking participant identities to study data will be stored separately in a password-protected file accessible only to the research team. Paper records will be maintained in locked facilities at Turku University Hospital, and no identifiable data will be shared outside the study team.
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 4
Контакты и местонахождение
Контакты исследования
- Имя: Panu Uusalo, MD, PhD
- Номер телефона: +35823133077
- Электронная почта: panu.uusalo@varha.fi
Учебное резервное копирование контактов
- Имя: Maarit Rantakokko, MD
- Электронная почта: maarit.rantakokko@varha.fi
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- 18 - 80 years of age
- Scheduled for a primary elective total hip arthroplasty
- Patient must be a candidate for same day discharge
- Informed consent understood and signed
- Patient is 160 - 186 cm tall
Exclusion Criteria:
- Scheduled bilateral THA
- Contraindication to or failed spinal anesthesia
- Allergy or contraindication to NSAIDs (e.g. chronic kidney disease)
- Diabetes requiring insulin medication
- Preoperative chronic use of illegal substances
- Renal insufficiency (eGFR < 60)
- Unstable psychiatric conditions
- Severe neurological disorder
- Cognitive deficiencies preventing informed consent
- Language barrier preventing completion of study
- Pregnancy or breastfeeding
- Chronic pain syndrome
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Тройной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: Ropivacaine
Patients receive spinal anesthesia with intrathecal ropivacaine
|
Patients receive spinal anesthesia with intrathecal ropivacaine
|
|
Активный компаратор: Bupivacaine
Patients receive spinal anesthesia with intrathecal bupivacaine
|
Patients receive spinal anesthesia with intrathecal bupivacaine
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Return of Sensory and Motor Function
Временное ограничение: 24 hours
|
24 hours
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Numeric Rating Scale (NRS) for Postoperative Pain
Временное ограничение: 24 hours
|
Pain intensity score assessed using the Numeric Rating Scale (NRS) for Pain (range 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain; higher scores indicate worse pain outcomes).
|
24 hours
|
|
Urinary retention
Временное ограничение: 24 hours
|
24 hours
|
|
|
Post-operative nausea and vomiting
Временное ограничение: 24 hours
|
24 hours
|
|
|
Postoperative opioid consumption in morphine milligram equivalents (MME)
Временное ограничение: 24 hours
|
24 hours
|
|
|
5-Point Likert Satisfaction Scale
Временное ограничение: 24 hours
|
Patient satisfaction score assessed using the 5-Point Likert Satisfaction Scale (range 1 to 5, where 1 indicates very dissatisfied and 5 indicates very satisfied; higher scores indicate better satisfaction outcomes).
|
24 hours
|
|
Perioperative hemodynamics
Временное ограничение: 24 hours
|
Mean, systolic, and diastolic arterial pressure measured by non-invasive oscillometric monitoring and heart rate measured by continuous ECG/pulse oximetry at 10-minute intervals intraoperatively and in the PACU.
Incidence of hypotension (MAP <65 mmHg) is also recorded.
Units of measure: mmHg, beats per minute, and % of patients with hypotensive episodes.
|
24 hours
|
|
Onset time of block
Временное ограничение: 24 hours
|
24 hours
|
|
|
Adequacy of anesthesia
Временное ограничение: 24 hours
|
Sensory block level assessed by cold sensation testing (dermatomal level) at 10-minute intervals following spinal anesthesia, and incidence of requirement for supplemental sedation or analgesia recorded from anesthesia and PACU charts.
Units of measure: dermatomal level (T-level) and % of patients requiring supplemental medication.
|
24 hours
|
|
Same day discharge rate
Временное ограничение: 24 hours
|
24 hours
|
|
|
Length of stay in the postoperative care unit and length of hospital stay
Временное ограничение: 72 hours
|
72 hours
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Директор по исследованиям: Panu Uusalo, MD, PhD, University of Turku and Turku University Hospital, Finland
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания опорно-двигательного аппарата
- Артрит
- Заболевания суставов
- Ревматические заболевания
- Остеоартрит
- Остеоартрит, тазобедренный сустав
- Органические химические вещества
- Анилиды
- Амиды
- Анилиновые соединения
- Амины
- Анестезия и анальгезия
- Анестезия, проводимость
- Анестезия
- Ропивакаин
- Бупивакаин
- Анестезия, спинной
Другие идентификационные номера исследования
- T2025/18111
- 2025-522358-38-02 (Ктис)
Планирование данных отдельных участников (IPD)
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Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .