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Hip OsteoarthritisPhase 4ROBUTHANCT07631091

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

A Phase 4 study testing Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml) and Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml) in people with Hip Osteoarthritis and Hip Arthroplasty Replacement, run by University of Turku.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml) and Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
No sites listed yet
Study dates
Jun 2026to May 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • Unstable psychiatric conditions
  • Severe neurological disorder
  • Cognitive deficiencies preventing informed consent
  • Language barrier preventing completion of study
  • Pregnancy or breastfeeding
  • Chronic pain syndrome

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Panu Uusalo, MD, PhD contact

+35823133077

panu.uusalo@varha.fi

Maarit Rantakokko, MD contact

maarit.rantakokko@varha.fi

About this study

Official title: 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.

Read the detailed description

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.

Being tested
Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml), Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml)Drug

    Patients receive spinal anesthesia with intrathecal ropivacaine

  • Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)Drug

    Patients receive spinal anesthesia with intrathecal bupivacaine

Study groups in NCT07631091
Study groupRoleWhat they receive
RopivacaineActive comparatorPatients receive spinal anesthesia with intrathecal ropivacaine
Receives: Drug: Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml)
BupivacaineActive comparatorPatients receive spinal anesthesia with intrathecal bupivacaine
Receives: Drug: Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Return of Sensory and Motor Function

    Measured: 24 hours

Secondary outcomes (10)
  1. Numeric Rating Scale (NRS) for Postoperative Pain

    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).

    Measured: 24 hours

  2. Urinary retention

    Measured: 24 hours

  3. Post-operative nausea and vomiting

    Measured: 24 hours

  4. Postoperative opioid consumption in morphine milligram equivalents (MME)

    Measured: 24 hours

  5. 5-Point Likert Satisfaction Scale

    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).

    Measured: 24 hours

  6. Perioperative hemodynamics

    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.

    Measured: 24 hours

  7. Onset time of block

    Measured: 24 hours

  8. Adequacy of anesthesia

    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.

    Measured: 24 hours

  9. Same day discharge rate

    Measured: 24 hours

  10. Length of stay in the postoperative care unit and length of hospital stay

    Measured: 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
176 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07631091
Sponsor's protocol ID
T2025/18111
Other IDs
2025-522358-38-02, 2025
Acronym
ROBUTHA
Status last verified
Jun 2026
First submitted
7 May 2026
Last updated
5 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml) and Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml) in people with Hip Osteoarthritis and Hip Arthroplasty Replacement, run by University of Turku.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Panu Uusalo, MD, PhD (+35823133077, panu.uusalo@varha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return of Sensory and Motor Function (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.

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