Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
162
Countries
1
Sites
1
Hip osteoarthrosis and postoperative pain
The aim of the study is to evaluate the efficacy, safety and suitability of isobaric ropivacaine spinal anesthesia compared with isobaric bupivacaine in patients undergoing primary total hip arthroplasty as ambulatory surgery.
Key facts
- Sponsor
- Turku University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2025-10-31
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Finnish State Research Funding (VTR) for university level health research.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Pharmacodynamic, Efficacy
The aim of the study is to evaluate the efficacy, safety and suitability of isobaric ropivacaine spinal anesthesia compared with isobaric bupivacaine in patients undergoing primary total hip arthroplasty as ambulatory surgery.
Secondary objectives 1
- Secondary objective of the study is to determine the appropriate dose of ropivacaine for these types of surgeries.
Conditions and MedDRA coding
Hip osteoarthrosis and postoperative pain
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-522358-38-01 | Post-operative analgesia and spinal block duration following total hip arthroplasties - comparison of single-shot intrathecal ropivacaine, and bupivacaine: a randomized, double blinded controlled study | Turku University Hospital |
| 2025-522358-38-00 | Post-operative analgesia and spinal block duration following total hip arthroplasties - comparison of single-shot intrathecal ropivacaine, and bupivacaine: a randomized, double blinded controlled study | Turku University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 18 – 80 years of age
- Scheduled for a primary elective total hip arthroplasty
- Patient must be a candidate for same day discharge as determined by local guidelines that will be published separately (incl. ASA 1-2, BMI < 35)
- Informed consent understood and signed
- Patient is 160 -186 cm tall
Exclusion criteria 12
- Scheduled bilateral THA
- Contraindication to or failed spinal anesthesia
- Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use)
- 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 form in Finnish
- Pregnancy or breastfeeding
- Chronic pain syndrome
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Return of sensory and motor function
Secondary endpoints 10
- Post-operative pain evaluated using the Numeric Rating Scale (NRS)
- Urinary retention
- Post-operative nausea and vomiting
- Postoperative opioid consumption in morphine milligram equivalents (MME)
- Patient satisfaction will be evaluated using a 5-point Likert scale
- Perioperative hemodynamics
- Onset time of block
- Adequacy of anesthesia
- Same day discharge rate
- Length of stay in the postoperative care unit and length of hospital stay
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ropivacain Fresenius Kabi 5 mg/ml injektioneste, liuos
PRD767205 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 16 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 27493
- MA holder
- FRESENIUS KABI AB
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Bicain Spinal 5 mg/ml injektioneste, liuos
PRD538106 · Product
- Active substance
- Bupivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRATHECAL USE
- Max daily dose
- 13.5 mg milligram(s)
- Max total dose
- 13.5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- 12054
- MA holder
- ORION CORPORATION
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Turku University Hospital
- Sponsor organisation
- Turku University Hospital
- Address
- Kiinamyllynkatu 4-8
- City
- Turku
- Postcode
- 20520
- Country
- Finland
Scientific contact point
- Organisation
- Turku University Hospital
- Contact name
- Panu Uusalo
Public contact point
- Organisation
- Turku University Hospital
- Contact name
- Panu Uusalo
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 162 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol 1_0 vs 1_3 track changes | 1 |
| Protocol (for publication) | ROBUTHA Protocol 1.6 (updated) | 1.6 |
| Protocol (for publication) | robutha-protocol 1_5_clean | 1.5 |
| Recruitment arrangements (for publication) | 11-robutha-selvitys -tutkimuspotilaiden rekrytoinnista 1 3 | 1.3 |
| Recruitment arrangements (for publication) | 14-robutha-case-report-form 1 3 | 1.5 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en | 1.3 |
| Recruitment arrangements (for publication) | robutha-case-report-form 1_4 vs 1_5 track changes | 1 |
| Subject information and informed consent form (for publication) | 3-robutha-subject-information-fin | 1.5 |
| Subject information and informed consent form (for publication) | 3-robutha-subject-information-fin ver 1_3 vs 1_4 track changes | 1 |
| Subject information and informed consent form (for publication) | 4-robutha-subject-consent 1 3 | 1.4 |
| Summary of Product Characteristics (SmPC) (for publication) | SPC Ropivacain Fresenius Kabi 5 mg_ml FIN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | spc-bicain-spinal-5mg_ml | 1.3 |
| Synopsis of the protocol (for publication) | ROBUTHA Synopsis of the protocol 1.6 (updated) | 1.6 |
| Synopsis of the protocol (for publication) | robutha-protocol-referred-eng 1_4 vs 1_5 track changes | 1 |
| Synopsis of the protocol (for publication) | robutha-protocol-referred-eng 1_5 | 1.5 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-03 | Finland | Acceptable 2025-10-31
|
2025-10-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-08 | Finland | Acceptable 2026-04-29
|
2026-04-30 |