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.
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
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthroplasty Replacement, Postoperative Pain After Ambulatory Surgery
- 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.
Maarit Rantakokko, MD contact
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.
- Conditions
- Hip Osteoarthritis, Hip Arthroplasty Replacement, Postoperative Pain After Ambulatory Surgery
- 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 group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | Patients receive spinal anesthesia with intrathecal ropivacaine Receives: Drug: Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml) |
| Bupivacaine | Active comparator | Patients 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.
Return of Sensory and Motor Function
Measured: 24 hours
Secondary outcomes (10)
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
Urinary retention
Measured: 24 hours
Post-operative nausea and vomiting
Measured: 24 hours
Postoperative opioid consumption in morphine milligram equivalents (MME)
Measured: 24 hours
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
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
Onset time of block
Measured: 24 hours
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
Same day discharge rate
Measured: 24 hours
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.
- First posted5 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital
- Responsible party
- Principal investigator, Panu Uusalo, University of Turku
- Investigators
- Panu Uusalo, MD, PhD, Study director, University of Turku and Turku University Hospital, Finland
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07631091
- Acronym / sponsor ID
- ROBUTHA / T2025/18111
- Conditions
- Hip Osteoarthritis, Hip Arthroplasty Replacement, Postoperative Pain After Ambulatory Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Turku University Hospital
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Drug: Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml)Patients receive spinal anesthesia with intrathecal ropivacaine |
| Bupivacaine | Active comparator | Drug: Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)Patients receive spinal anesthesia with intrathecal bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Anesthesia with Ropivacaine 15 mg (5 mg/ml)Patients receive spinal anesthesia with intrathecal ropivacaine | Drug | Ropivacaine |
| Spinal Anesthesia with Bupivacaine 11 mg (5 mg/ml)Patients receive spinal anesthesia with intrathecal bupivacaine | Drug | Bupivacaine |
Primary outcome
Return of Sensory and Motor Function
Time frame: 24 hours
10 secondary outcomes
Numeric Rating Scale (NRS) for Postoperative Pain
Time frame: 24 hours
Urinary retention
Time frame: 24 hours
Post-operative nausea and vomiting
Time frame: 24 hours
Postoperative opioid consumption in morphine milligram equivalents (MME)
Time frame: 24 hours
5-Point Likert Satisfaction Scale
Time frame: 24 hours
Perioperative hemodynamics
Time frame: 24 hours
Onset time of block
Time frame: 24 hours
Adequacy of anesthesia
Time frame: 24 hours
Same day discharge rate
Time frame: 24 hours
Length of stay in the postoperative care unit and length of hospital stay
Time frame: 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maarit Rantakokko, MD contact
Panu Uusalo, MD, PhD study director
University of Turku and Turku University Hospital, Finland
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.