Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Not authorised
Participants planned
20
Countries
1
Sites
1
Hip Pain
To investigate the frequency of anesthesia of the obturator nerve after subpectineal obturator nerve blockade (SOB) vs. suprainguinal fascia iliaca compartment block (SIFICB) in healthy volunteers.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Decision date (initial)
- 2024-04-16
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Health Research Foundation of Central Denmark Region · Salling Foundation
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To investigate the frequency of anesthesia of the obturator nerve after subpectineal obturator nerve blockade (SOB) vs. suprainguinal fascia iliaca compartment block (SIFICB) in healthy volunteers.
Conditions and MedDRA coding
Hip Pain
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | The effect of suprainguinal fascia iliaca compartment block - A healthy volunteer trial The volunteer trial subjects will be examined one day for 3-5 hours. There will be no follow up after the end of the study day
|
Randomised Controlled | Double | [{"id":50785,"code":1,"name":"Subject"},{"id":50786,"code":4,"name":"Analyst"},{"id":50787,"code":2,"name":"Investigator"},{"id":50783,"code":3,"name":"Monitor"},{"id":50784,"code":5,"name":"Carer"}] | SIFCB active (right or left): 39 ml Ropivacaine 3.75 mg/ml + (0.26 ml Gadoteric acid 279,3 mg/ml diluted with 0.4 ml isotonic saline (NaCl)) SIFICB placebo (right or left): 40 ml NaCl isotonic saline (NaCl) SOB active (right or left): 15 ml Ropivacaine 3,75 mg/ml SOB placebo (right or left): 15 ml isotonic saline (NaCl) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- American Society of Anesthesiologists physical status classification score (ASA) I-II
- Age ≥ 18 years
- BMI < 25 kg/m²
- Able to read and understand Danish as well as read, understand and sign informed written consent
- Weight ≥ 69 kg
Exclusion criteria 17
- Inability to cooperate
- Unable to speak and understand Danish
- Fear of needles
- Claustrophobia
- Metallic implants in the body incl. pacemaker
- Known reduced kidney function
- Known reduced liver function
- Previously operated on in the hip area or groin
- Known neuropathy in the lower extremities
- Decreased sense of touch on the lower extremities assessed by examination by the investigator before the start of the trial
- Known coagulopathy
- Infection in the areas of insertion sites for nerve blocks and EMG examination
- Allergy to local analgesics used in the study (Ropivacaine)
- Allergy to contrast agents for MR scanning (Gadoteric acid)
- Daily medication consumption besides oral contraception
- Abuse of alcohol, drugs or medication
- Pregnancy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 5
- Incidence of spread of injectate to ON after SIFICB estimated by MR-Imaging
- Dynamometer muscle strength measurement of adductor and quadriceps muscles after SOB vs. SIFICB
- Incidence of cutaneous anesthesia after active SOB
- Localization of cutaneous anesthesia after active SOB
- Area of cutaneous anesthesia after active SOB
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Dotarem, injektionsvæske, opløsning i enkeltdosisbeholder. i.v.
PRD354058 · Product
- Active substance
- Gadoteric Acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 0.26 ml millilitre(s)
- Max total dose
- 0.26 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08CA02 — GADOTERIC ACID
- Marketing authorisation
- 17091
- MA holder
- GUERBET
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD767198 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 206 mg milligram(s)
- Max total dose
- 206 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 45010
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid Fresenius Kabi 9 mg/ml
PRD2503457 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLVENT FOR PARENTERAL USE
- Route of administration
- PERINEURAL USE
- Max daily dose
- 55 ml millilitre(s)
- Max total dose
- 55 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA03 — SODIUM CHLORIDE
- Marketing authorisation
- 17927
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- Thomas Fichtner Bendtsen
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- Thomas Fichtner Bendtsen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Not authorised | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-02 | Denmark | Not acceptable 2024-04-11
|
2024-04-16 |