Clinical trial • Not applicable • Musculoskeletal|Other

Ropivacaine hydrochloride for Total hip arthroplasty

Not applicable trial of Ropivacaine hydrochloride for Total hip arthroplasty.

Overview

Trial Therapeutic Area
Musculoskeletal|Other
Trial Disease
Total hip arthroplasty
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
23-12-2024
First CTIS Authorization Date
24-04-2025

Trial design

Randomised, placebo: sodium chloride (solution for injection), route intra-articular, product record indicates max total dose 20 ml; test intervention: ropivacaine hydrochloride (solution for injection), route intra-articular, product record indicates max total dose 20 ml.-controlled Not applicable trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Placebo: SODIUM CHLORIDE (solution for injection), route intra-articular, product record indicates max total dose 20 ml; Test intervention: ROPIVACAINE HYDROCHLORIDE (solution for injection), route intra-articular, product record indicates max total dose 20 ml.
Target Sample Size
120

Eligibility

Recruits 120 Vulnerable population not selected; participants must be >18 years and able and willing to provide written informed consent. Consent obtained from the adult participant (no assent/parental consent procedures described)..

Vulnerable Population
Vulnerable population not selected; participants must be >18 years and able and willing to provide written informed consent. Consent obtained from the adult participant (no assent/parental consent procedures described).

Inclusion criteria

  • {"criterion_text":"- Age > 18 years"}
  • {"criterion_text":"- On the waiting list for primary THA via the ASI by one of participating orthopaedic surgeons"}
  • {"criterion_text":"- ASA 1, ASA 2 or ASA 3"}
  • {"criterion_text":"- Eligible to receive the full enhanced recovery pain- and anesthetic protocol"}
  • {"criterion_text":"- Willing to participate"}
  • {"criterion_text":"- Willing to provide written informed consent"}

Exclusion criteria

  • {"criterion_text":"- Decline to participate"}
  • {"criterion_text":"- Participants will be excluded postoperatively if the duration of surgery exceeds 90 minutes"}
  • {"criterion_text":"- Unable to effectively communicate in Dutch or English"}
  • {"criterion_text":"- ASA 4"}
  • {"criterion_text":"- Use of opioids preoperatively"}
  • {"criterion_text":"- Use of NSAID’s for an indication other than the hip for which surgery is planned"}
  • {"criterion_text":"- Allergy or contraindication for the contents (Ropivacaine or adrenaline) of the preoperative infiltration"}
  • {"criterion_text":"- Allergy or contraindication for medication used in the standardized postoperative pain protocol"}
  • {"criterion_text":"- Allergy or contraindication for medication used in the standardized anaesthetic protocol"}
  • {"criterion_text":"- Allergy or contraindication for the standardized escape medication"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Use of escape pain medication during the first 6 hours after the intra-articular injection of the hip","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Percentage of patients that use escape pain medication on day 0 and during hospital stay until discharge","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Pain measured with NRS","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Side effects related to the use of pain medication","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Amount of other escape medication used","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Satisfaction measured with the Net Promotor Score (NPS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Perioperative blood loss","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Need for blood tranfusion","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
120
Recruitment Window Months
24
Consent Approach
Written informed consent required from each participant; adults only (>18). Subject information and informed consent form (L1_SIS and ICF adults) provided. Study excludes participants unable to communicate effectively in Dutch or English, indicating consent materials and communication in Dutch and English.

Geography

Total Number Of Sites
1
Total Number Of Participants
120

Netherlands

Earliest CTIS Part Ii Submission Date
15-04-2025
Latest Decision Or Authorization Date
24-04-2025
Processing Time Days
9
Number Of Sites
1
Number Of Participants
120

Sites

Site Name
Reinier Haga Groep Orthopedisch Centrum B.V.
Department Name
Orthopedic Department
Contact Person Name
Stephan Vehmeijer
Contact Person Email
s.vehmeijer@rhoc.nl
Number Of Participants
120

Sponsor

Primary sponsor

Full Name
Reinier Haga Groep Orthopedisch Centrum B.V.
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
ROPIVACAINE HYDROCHLORIDE
Active Substance
Ropivacaine hydrochloride
Modality
Small molecule
Routes Of Administration
INTRA-ARTICULAR INJECTION
Route
INTRA-ARTICULAR INJECTION
Authorisation Status
prodAuthStatus: 2
Maximum Dose
20 ml
Investigational Product Name
SODIUM CHLORIDE
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
INTRAARTICULAR USE
Route
INTRAARTICULAR USE
Authorisation Status
prodAuthStatus: 2
Maximum Dose
20 ml
Combination Treatment
Yes

Related trials

Other published trials that may interest you.