Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Not authorised
Participants planned
30
Countries
1
Sites
1
Breast cancer
The main objective is to determine the clinical efficacy of the intertransverse process block.
Key facts
- Sponsor
- Zealand University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2022-10-14
- 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, Efficacy, Safety
The main objective is to determine the clinical efficacy of the intertransverse process block.
Conditions and MedDRA coding
Breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients scheduled for day case elective unilateral minor breast cancer (including DCIS) surgery
- Age ≥ 18 years at the date of inclusion
- American Associations of Anaesthesiologist (ASA) class I-III
- Have received thorough information, orally and in written form, and signed the “Informed Consent” form on participation in the study.
- Weight > 52,5 kilograms (chosen due to the maximum single dose of Ropivacaine (3mg/kg))
Exclusion criteria 15
- Substantial co-morbidity: American Associations of Anaesthesiologist (ASA) class > III
- Inability to speak and understand Danish
- Inability to cooperate
- Allergy to study drugs
- Daily intake of analgesics (investigators decision)
- Alcohol and/or drug overuse (investigators decision)
- Previous thoracic trauma or thoracic surgery
- Previous/current piercing of the nipple of any kind on blockade side
- Tattoos on the thorax (according to the investigators decision)
- Any systemic muscular or neuromuscular disease
- Any use of vasodilatory substance (investigators decision)
- Local infection at the site of injection or systemic infection
- Difficult sonoanatomical visualisation of the target area (SCTL, ITTC etc.) necessary for the block execution
- Severe hypovolemia
- Pregnant or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary outcome of this procedure related study is the number of anaesthetised thoracic dermatomes
Secondary endpoints 4
- “Sensory mapping”: the extent of cutaneous spread of the sensory block (area in cm2)
- To evaluate thermography in a clinical setup (the temperature differences between non-blockade side and blockade side)
- To evaluate changes in non-invasive blood pressure
- To evaluate block application numeric rating scale scores
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Ropivacain Fresenius Kabi 7,5 mg/ml, injektionsvätska, lösning
PRD767208 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 3.0 mg/Kg milligram(s)/kilogram
- Max total dose
- 3.0 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 42454
- MA holder
- FRESENIUS KABI AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Anhydrous Lidocaine Hydrochloride
SCP47394575 · ATC
- Active substance
- Anhydrous Lidocaine Hydrochloride
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 5.0 mg/Kg milligram(s)/kilogram
- Max total dose
- 5.0 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP43025870 · ATC
- Route of administration
- INTRAVENOUS
- Max daily dose
- 40 µg/Kg microgram(s)/kilogram
- Max total dose
- 40 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01AH02 — ALFENTANIL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zealand University Hospital
- Sponsor organisation
- Zealand University Hospital
- Address
- Sygehusvej 10
- City
- Roskilde
- Postcode
- 4000
- Country
- Denmark
Scientific contact point
- Organisation
- Zealand University Hospital
- Contact name
- Jens Børglum
Public contact point
- Organisation
- Zealand University Hospital
- Contact name
- Jens Børglum
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Not authorised | 30 | 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 | 2022-07-15 | Denmark | Not acceptable 2022-10-14
|
2022-10-14 |