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Post-Operative Spinal Block Duration and Pain Relief After Hip Replacement Surgery: Comparing Single-Shot Spinal Ropivacaine and Bupivacaine (ROBUTHA)

2 de junio de 2026 actualizado por: Panu Uusalo, University of Turku

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

This study aims to determine whether isobaric ropivacaine is more suitable than isobaric bupivacaine for spinal anesthesia in outpatient total hip arthroplasty (THA). The study will evaluate whether ropivacaine allows faster recovery of sensory and motor function while still providing adequate surgical anesthesia and postoperative pain control. Additional aims are to assess the effects of the anesthetic technique on same-day discharge rates, postoperative recovery, urinary retention, opioid consumption, and patient satisfaction after outpatient THA.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

176

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Panu Uusalo, MD, PhD
  • Número de teléfono: +35823133077
  • Correo electrónico: panu.uusalo@varha.fi

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Ropivacaine
Patients receive spinal anesthesia with intrathecal ropivacaine
Patients receive spinal anesthesia with intrathecal ropivacaine
Comparador activo: Bupivacaine
Patients receive spinal anesthesia with intrathecal bupivacaine
Patients receive spinal anesthesia with intrathecal bupivacaine

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Return of Sensory and Motor Function
Periodo de tiempo: 24 hours
24 hours

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Numeric Rating Scale (NRS) for Postoperative Pain
Periodo de tiempo: 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
Periodo de tiempo: 24 hours
24 hours
Post-operative nausea and vomiting
Periodo de tiempo: 24 hours
24 hours
Postoperative opioid consumption in morphine milligram equivalents (MME)
Periodo de tiempo: 24 hours
24 hours
5-Point Likert Satisfaction Scale
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 24 hours
24 hours
Adequacy of anesthesia
Periodo de tiempo: 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
Periodo de tiempo: 24 hours
24 hours
Length of stay in the postoperative care unit and length of hospital stay
Periodo de tiempo: 72 hours
72 hours

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Director de estudio: Panu Uusalo, MD, PhD, University of Turku and Turku University Hospital, Finland

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de mayo de 2028

Fechas de registro del estudio

Enviado por primera vez

7 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2026

Publicado por primera vez (Actual)

5 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • T2025/18111
  • 2025-522358-38-02 (Ctis)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared because the study data contain sensitive personal health information collected from a relatively small patient population at a single study center. Due to the limited sample size and detailed clinical information, there is a risk that participants could be indirectly identifiable even after de-identification. Data sharing is therefore restricted in order to protect participant privacy and confidentiality in accordance with applicable data protection legislation, institutional policies, and the informed consent provided by study participants.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .