Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
40
Countries
1
Sites
1
Pain
To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita.
Key facts
- Sponsor
- Ordensklinikum Linz GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 7 May 2024 → 22 May 2024
- Decision date (initial)
- 2024-03-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Ordenklinikum Linz GmbH, Barmherzige Schwestern
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To demonstrate a reduction of pain caused by PIVC rated by Numerical Rating Scale (NRS), after application of a 10% lidocaine spray- Separately measured for the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita.
Secondary objectives 7
- To measure pain caused by PIVC rated by NRS in the dominant vs. non-dominant arm
- To measure pain caused by PIVC rated by NRS at the plantar side of the hand/vessel at the dorsum manus, vs. at the forearm/cubita
- To measure the correlation between pain caused by PIVC rated by NRS and the anticipated pain rated by NRS
- To measure the correlation between pain caused by PIVC rated by NRS and the anticipated difficulty by the operator to insert the PIVC
- To measure pain rated by NRS depending on success
- To describe success rates and compare it
- To measure the correlation between PCS and pain caused by PIVC rated by NRS
Conditions and MedDRA coding
Pain
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | VENLID Description of Randomization.
4 randomization groups are defined per protocol.
"Dominant" refers to the stronger hand/forearm.
o Group A: dominant plantar side of hand-Dorsum Manus /Placebo – non-dominant plantar side of hand-Dorsum Manus /LA
o Group B: non-dominant plantar side of hand-Dorsum Manus /Placebo – dominant plantar side of hand-Dorsum Manus /LA
o Group C: non-dominant plantar side of hand-Dorsum /LA – dominant plantar side of hand-Dorsum /Placebo
o Group D: dominant plantar side of hand-Dorsum /LA – non-dominant plantar side of hand-Dorsum /Placebo
o Group A: dominant forearm-cubita /placebo/Placebo – non-dominant forearm-cubita /LA
o Group B: non-dominant forearm-cubita /Placebo – dominant forearm-cubita /LA
o Group C: non-dominant forearm-cubita m /LA – dominant forearm-cubita /Placebo
o Group D: dominant forearm-cubita /LA – non-dominant forearm-cubita /Placebo
Four bottles (a,b,c,d) are prepared by the pharmacy. Two bottles are filled with placebo and two bottles with the local anesthetic. The content of these bottles are only known by the Sponsor and the pharmacy.
Bottle a= local anesthetic (vessel at the dorsum manus)
Bottle b= placebo (vessel at the dorsum manus)
Bottle c= placebo (forearm/cubita)
Bottle d= local anesthetic (forearm/cubita)
On the treatment day the subinvestigator will obtain a card for each subject in which the treatment for each subject is specified. There are 40 cards and each card specifies the treatment protocol for a single subject. See attached document 2023-507859-29 Randimization cards.
Neither the subinvestigator nor the subjects will know what the content of the bottles are.
The plantar side of the hand and the forearm/cubita are randomized separately into the four groups A,B,C,D. Afterwards hand and arm are combined with each other. See attached document 2023-507859-29 Randomization key.
Two separate block randomizations are forseen for the plantar side of the hand/vessel at the dorsum manus and for forearm/cubita via Software R version 4.2.2 (R Core Team, 2022) and Package blockrand version 1.5 (Snow, 2020). Each 2 blocks with a block length of 20. This resulting list is only accessible for the sponsor.
Only the principal investigator will be accountable for the medication and placebo throughout the study and knows how the numbers are assigned to the groups.
Lidocaine spray 10 % (Xylocaine 10% pump spray) and the placebo, physiological saline solution (NaCl 0,9%), are filled in neutral brown glass bottles. 2 bottles for each of them. 2 bottles with the label "a" and "b" for plantar side of hand/Vessel at the dorsum manus and 2 bottles with the label "c" and "d" for forearm/cubita. One bottle of each them ("a" and "b") is placebo and the other one the local anaesthetic. The same for bottles "c" and "d".
|
Randomised Controlled | Double | [{"id":44948,"code":1,"name":"Subject"},{"id":44946,"code":3,"name":"Monitor"},{"id":44947,"code":2,"name":"Investigator"}] | Group A: dominant/placebo - non-dominant/LA (local anaesthetic) Group B: non-dominant/placebo - dominant/LA (local anaesthetic) Group C: non-dominant/LA (local anaesthetic) - dominant/placebo Group D: dominant/LA (local anaesthetic) - non-dominant/placebo |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Female volunteers 18-45 years
- Personal history of ever having a venipuncture or insertion of PIVC
Exclusion criteria 11
- Fractures on the upper extremity resulting in permanent movement restriction
- Significant burns on the upper extremity-at the discretion of the principal investgator
- Personal history of any thrombosis
- Personal history of chemotherapy
- Potential allergy to a PIVC
- Personal history of surgery in the axilla
- Personal history of any pathologies in the blood coagulation pathway
- Personal history of difficult peripheral venous access
- Personal history of complications with a PIVC
- Any concomitant use of an analgesic within the previous 24 h
- Any concomitant use of anticoagulation
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain caused by PIVC rated by NRS separately for the back of the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita.
Secondary endpoints 7
- Pain caused by PIVC rated by NRS separately for the back of the plantar side of the hand/vessel at the dorsum manus, and for the forearm/cubita.
- Pain caused by PIVC at the plantar side of the hand/vessel at the dorsum manus, vs. at the forearm/cubita
- Correlation between pain caused by PIVC and the anticipated pain
- Correlation between pain caused by PIVC and the anticipated difficulty by the operator to insert the PIVC
- Success rate of the venepuncture by descriptive analysis and comparison
- Pain caused by PIVC broken down by success/failure of insertion of PIVC
- Correlation between pain caused by PIVC and PCS
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD4776848 · Product
- Active substance
- Lidocaine
- Pharmaceutical form
- CUTANEOUS SPRAY
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 100 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- PL 39699/0086
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Physiologische Kochsalzlösung „Fresenius“ - Infusionslösung
PRD2128225 · Product
- Active substance
- Sodium Chloride
- Substance synonyms
- SODIUM CHLORID, SODIUM CHLORIDE (FOR PH ADJUSTMENT)
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 40 millilitre(s)/kilogram
- Max total dose
- 40 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 1-16417
- MA holder
- FRESENIUS KABI AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ordensklinikum Linz GmbH
- Sponsor organisation
- Ordensklinikum Linz GmbH
- Address
- Seilerstaette 4
- City
- Linz
- Postcode
- 4020
- Country
- Austria
Scientific contact point
- Organisation
- Ordensklinikum Linz GmbH
- Contact name
- Prim. Univ.-Prof. Dr. Hefler, MBA
Public contact point
- Organisation
- Ordensklinikum Linz GmbH
- Contact name
- Prim. Univ.-Prof. Dr. Hefler, MBA
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 40 | 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 |
|---|---|---|---|---|---|
| Austria | 2024-05-07 | 2024-05-22 | 2024-05-07 | 2024-05-22 |
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 |
|---|---|---|---|
| Study Report 29JAN2025, Study Protocol V3 17MAY2024 Public Redacted, RFI-CT-2023-507859-29-00 final SUM-68681
|
2025-01-31T11:21:00 | Submitted | Summary of Results |
| Study Protocol V3 17MAY2024 MS SUM-68682
|
2025-01-31T11:17:28 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| VENLID Study Poster 2023-507859-29 | 2025-10-20T09:06:52 | Submitted | Laypersons Summary of Results |
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | VENLID Poster 2023-507859-29_Public Redacted | 1 |
| Summary of results (for publication) | Clinical Study Report VENLID 2023-507859-29_MS 14012025 | 1 |
| Summary of results (for publication) | D1_Protocol 2023-507859-29_ENG V3_MS | 3 |
| Summary of results (for publication) | D1_Protocol 2023-507859-29_ENG V3_MS_TC | 3 |
| Summary of results (for publication) | D1_Protocol 2023-507859-29_ENG V3_Public Redacted | 3 |
| Summary of results (for publication) | D1_Protocol 2023-507859-29_ENG V3_Public Redacted_TC | 3 |
| Summary of results (for publication) | RFI-CT- 2023-507859-29-00 Conditions final | 1 |
| Summary of results (for publication) | RFI-CT- 2023-507859-29-00 Conditions final sig | 1 |
| Summary of results (for publication) | Statement to final study report and RFI I conclusion_ 29012025 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-10 | Austria | Acceptable with conditions 2024-03-11
|
2024-03-18 |