Clinical trial • Phase IV • Musculoskeletal
ropivacaine hydrochloride for Hip pain
Phase IV trial of ropivacaine hydrochloride for Hip pain.
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Hip pain
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule|Diagnostic agent
Key dates
- Initial CTIS Submission Date
- 02-02-2024
Trial design
Randomised, arms: - sifcb active: 39 ml ropivacaine 3.75 mg/ml + 0.26 ml gadoteric acid 279.3 mg/ml diluted with 0.4 ml isotonic saline (nacl) (right or left) - sificb placebo: 40 ml isotonic saline (nacl) (right or left) - sob active: 15 ml ropivacaine 3.75 mg/ml (right or left) - sob placebo: 15 ml isotonic saline (nacl) (right or left)-controlled Phase IV trial across 1 site in Denmark.
- Randomised
- Yes
- Comparator
- Arms: - SIFCB active: 39 ml Ropivacaine 3.75 mg/ml + 0.26 ml Gadoteric acid 279.3 mg/ml diluted with 0.4 ml isotonic saline (NaCl) (right or left) - SIFICB placebo: 40 ml isotonic saline (NaCl) (right or left) - SOB active: 15 ml Ropivacaine 3.75 mg/ml (right or left) - SOB placebo: 15 ml isotonic saline (NaCl) (right or left)
- Target Sample Size
- 20
- Trial Duration For Participant
- 1
Eligibility
Recruits 20 No vulnerable population selected. Subjects are adult healthy volunteers; informed written consent is required and participants must be able to read and understand Danish and sign the consent..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- No vulnerable population selected. Subjects are adult healthy volunteers; informed written consent is required and participants must be able to read and understand Danish and sign the consent.
Inclusion criteria
- {"criterion_text":"- American Society of Anesthesiologists physical status classification score (ASA) I-II\n- Age ≥ 18 years\n- BMI < 25 kg/m²\n- Able to read and understand Danish as well as read, understand and sign informed written consent\n- Weight ≥ 69 kg"}
Exclusion criteria
- {"criterion_text":"- Inability to cooperate\n- Decreased sense of touch on the lower extremities assessed by examination by the investigator before the start of the trial\n- Known coagulopathy\n- Infection in the areas of insertion sites for nerve blocks and EMG examination\n- Allergy to local analgesics used in the study (Ropivacaine)\n- Allergy to contrast agents for MR scanning (Gadoteric acid)\n- Daily medication consumption besides oral contraception\n- Abuse of alcohol, drugs or medication\n- Pregnancy\n- Unable to speak and understand Danish\n- Fear of needles\n- Claustrophobia\n- Metallic implants in the body incl. pacemaker\n- Known reduced kidney function\n- Known reduced liver function\n- Previously operated on in the hip area or groin\n- Known neuropathy in the lower extremities"}
Endpoints
Primary endpoints
- {"endpoint_text":"- The frequency of anesthesia of ON after SOB vs. SIFICB in healthy volunteer subjects. Anesthesia of ON is estimated as significant (≥50 %) reduction of electrical amplitude of EMG signal when measured on the gracilis muscle when comparing values before and after blockade","definition_or_measurement_approach":"Anesthesia of ON defined as ≥50% reduction of electrical amplitude of EMG signal measured on the gracilis muscle comparing values before and after blockade"}
Secondary endpoints
- {"endpoint_text":"- Incidence of spread of injectate to ON after SIFICB estimated by MR-Imaging","definition_or_measurement_approach":"Estimated by MR-Imaging"}
- {"endpoint_text":"- Dynamometer muscle strength measurement of adductor and quadriceps muscles after SOB vs. SIFICB","definition_or_measurement_approach":"Measured using dynamometer muscle strength measurement"}
- {"endpoint_text":"- Incidence of cutaneous anesthesia after active SOB","definition_or_measurement_approach":""}
- {"endpoint_text":"- Localization of cutaneous anesthesia after active SOB","definition_or_measurement_approach":""}
- {"endpoint_text":"- Area of cutaneous anesthesia after active SOB","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 11
- Consent Approach
- Written informed consent required from adult participants. Participants must be able to read and understand Danish and sign informed written consent. No assent procedures or other languages specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Denmark
- Earliest CTIS Part Ii Submission Date
- 22-03-2024
- Latest Decision Or Authorization Date
- 16-04-2024
- Processing Time Days
- 25
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Region Midtjylland - Regionshospitalet Horsens
- Department Name
- Bedøvelse, Operation og Intensiv, Regionshospitalet Horsens
- Principal Investigator Name
- Christian Jessen
- Principal Investigator Email
- chijss@rm.dk
- Contact Person Name
- Christian Jessen
- Contact Person Email
- chijss@rm.dk
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Region Midtjylland
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}
Investigational products
- Investigational Product Name
- Ropivacain Fresenius Kabi
- Active Substance
- ropivacaine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- PERINEURAL USE
- Route
- Perineural
- Authorisation Status
- Authorised (marketing authorisation number 45010 in DK)
- Starting Dose
- 15 ml of Ropivacaine 3.75 mg/ml (SOB active) and 39 ml of Ropivacaine 3.75 mg/ml (SIFCB active)
- Dose Levels
- 15 ml (3.75 mg/ml); 39 ml (3.75 mg/ml)
- Frequency
- Single administration on study day
- Maximum Dose
- 206 mg total (as recorded in product data)
- Investigational Product Name
- Dotarem, injektionsvæske, opløsning i enkeltdosisbeholder. i.v.
- Active Substance
- gadoteric acid
- Modality
- Diagnostic agent
- Routes Of Administration
- PERINEURAL USE
- Route
- Perineural
- Authorisation Status
- Authorised (marketing authorisation number 17091 in DK)
- Starting Dose
- 0.26 ml Gadoteric acid 279.3 mg/ml diluted with 0.4 ml isotonic saline (NaCl) (administered with Ropivacaine in SIFCB active)
- Dose Levels
- 0.26 ml (279.3 mg/ml) diluted with 0.4 ml NaCl
- Frequency
- Single administration on study day
- Maximum Dose
- 0.26 ml (as recorded in product data)
- Investigational Product Name
- Natriumklorid Fresenius Kabi 9 mg/ml
- Active Substance
- sodium chloride
- Modality
- Small molecule
- Routes Of Administration
- PERINEURAL USE
- Route
- Perineural
- Authorisation Status
- Authorised (marketing authorisation number 17927 in DK)
- Starting Dose
- 40 ml isotonic saline (NaCl) as SIFICB placebo; 15 ml isotonic saline (NaCl) as SOB placebo
- Dose Levels
- 15 ml; 40 ml
- Frequency
- Single administration on study day
- Maximum Dose
- 55 ml
- Combination Treatment
- Yes
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