Overview
Sponsor-declared trial summary
Total Hip Arthroplasty / THA
The main objective is to determine if preoperative intra-articular infiltration (IAI) of the hip joint with Ropivacaine and Adrenaline reduces the number of patients needing postoperative escape pain medication after total hip arthroplasty, compared to a placebo AIA of the hip joint.
Key facts
- Sponsor
- Reinier Haga Groep Orthopedisch Centrum B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Decision date (initial)
- 2025-04-24
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The main objective is to determine if preoperative intra-articular infiltration (IAI) of the hip joint with Ropivacaine and Adrenaline reduces the number of patients needing postoperative escape pain medication after total hip arthroplasty, compared to a placebo AIA of the hip joint.
Conditions and MedDRA coding
Total Hip Arthroplasty / THA
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10020104 | Hip total replacement | 10042613 |
| 21.1 | LLT | 10044088 | Total hip replacement | 10042613 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-509109-57-00 | Hip Infiltration in Hip Arthroplasty (HiHa) study – a randomized controlled trial | Reinier Haga Groep Orthopedisch Centrum B.V. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age > 18 years
- On the waiting list for primary THA via the ASI by one of participating orthopaedic surgeons
- ASA 1, ASA 2 or ASA 3
- Eligible to receive the full enhanced recovery pain- and anesthetic protocol
- Willing to participate
- Willing to provide written informed consent
Exclusion criteria 10
- Decline to participate
- Unable to effectively communicate in Dutch or English
- ASA 4
- Use of opioids preoperatively
- Use of NSAID’s for an indication other than the hip for which surgery is planned
- Allergy or contraindication for the contents (Ropivacaine or adrenaline) of the preoperative infiltration
- Allergy or contraindication for medication used in the standardized postoperative pain protocol
- Allergy or contraindication for medication used in the standardized anaesthetic protocol
- Allergy or contraindication for the standardized escape medication
- Participants will be excluded postoperatively if the duration of surgery exceeds 90 minutes
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Use of escape pain medication during the first 6 hours after the intra-articular injection of the hip
Secondary endpoints 7
- Percentage of patients that use escape pain medication on day 0 and during hospital stay until discharge
- Pain measured with NRS
- Side effects related to the use of pain medication
- Amount of other escape medication used
- Satisfaction measured with the Net Promotor Score (NPS)
- Perioperative blood loss
- Need for blood tranfusion
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB04264MIG · Substance
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRA-ARTICULAR INJECTION
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB12581MIG · Substance
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAARTICULAR USE
- Max daily dose
- 20 ml millilitre(s)
- Max total dose
- 20 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Reinier Haga Groep Orthopedisch Centrum B.V.
- Sponsor organisation
- Reinier Haga Groep Orthopedisch Centrum B.V.
- Address
- Toneellaan 2
- City
- Zoetermeer
- Postcode
- 2725 NA
- Country
- Netherlands
Scientific contact point
- Organisation
- Reinier Haga Groep Orthopedisch Centrum B.V.
- Contact name
- N.M.C. Mathijssen
Public contact point
- Organisation
- Reinier Haga Groep Orthopedisch Centrum B.V.
- Contact name
- N.M.C. Mathijssen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 120 | 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 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2023-509109-57-01 | 2.1 |
| Protocol (for publication) | D1_Protocol EU CT 2023-509109-57-01 tracked changes | 2.1 |
| Recruitment arrangements (for publication) | K1 Recruitment procedure 21-03-2025 Tracked changes | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults Tracked changes | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ropivacaine Fresenius Kabi 7_5 mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS EU 2023-509109-57-01 - DUTCH | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-23 | Netherlands | Acceptable 2025-04-22
|
2025-04-24 |