- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 4
Kontakty a umístění
Studijní kontakt
- Jméno: Panu Uusalo, MD, PhD
- Telefonní číslo: +35823133077
- E-mail: panu.uusalo@varha.fi
Studijní záloha kontaktů
- Jméno: Maarit Rantakokko, MD
- E-mail: maarit.rantakokko@varha.fi
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Aktivní komparátor: Ropivacaine
Patients receive spinal anesthesia with intrathecal ropivacaine
|
Patients receive spinal anesthesia with intrathecal ropivacaine
|
|
Aktivní komparátor: Bupivacaine
Patients receive spinal anesthesia with intrathecal bupivacaine
|
Patients receive spinal anesthesia with intrathecal bupivacaine
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Return of Sensory and Motor Function
Časové okno: 24 hours
|
24 hours
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Numeric Rating Scale (NRS) for Postoperative Pain
Časové okno: 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
Časové okno: 24 hours
|
24 hours
|
|
|
Post-operative nausea and vomiting
Časové okno: 24 hours
|
24 hours
|
|
|
Postoperative opioid consumption in morphine milligram equivalents (MME)
Časové okno: 24 hours
|
24 hours
|
|
|
5-Point Likert Satisfaction Scale
Časové okno: 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
Časové okno: 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
Časové okno: 24 hours
|
24 hours
|
|
|
Adequacy of anesthesia
Časové okno: 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
Časové okno: 24 hours
|
24 hours
|
|
|
Length of stay in the postoperative care unit and length of hospital stay
Časové okno: 72 hours
|
72 hours
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Panu Uusalo, MD, PhD, University of Turku and Turku University Hospital, Finland
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- T2025/18111
- 2025-522358-38-02 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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