Overview
Sponsor-declared trial summary
The ITP block is primarily used for pain amelioration after breast cancer surgery.
The main overall objective is to determine the efficacy of the intertransverse process block.
Key facts
- Sponsor
- Zealand University Hospital
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 26 Feb 2023 → 8 Mar 2023
- Decision date (initial)
- 2023-01-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The main overall objective is to determine the efficacy of the intertransverse process block.
Conditions and MedDRA coding
The ITP block is primarily used for pain amelioration after breast cancer surgery.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Male sex
- Age ≥ 18 years at the date of inclusion
- American Associations of Anaesthesiologist (ASA) class I-II
- 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 international maximal single dose of Ropivacaine (3mg/kg)
Exclusion criteria 14
- Substantial co-morbidity: American Associations of Anaesthesiologist (ASA) class > II
- 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
- 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)
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 satisfaction in numeric rating scale pain 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 1
—
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 | Ended | 12 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-02-26 | 2023-03-08 | 2023-02-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results SUM-108791
|
2025-11-30T13:04:09 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2025-11-30T13:04:45 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay person summary of results | 1 |
| Summary of results (for publication) | Summary of results CTIS | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-23 | Denmark | Acceptable 2023-01-23
|
2023-01-24 |