Phase 4
Completed N=40
VENLID: The Application of a 10%-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults
Source: ClinicalTrials.gov NCT06354816 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Pain Difference Caused by PIVC (Peripheral Intravenous Catheter) Rated by NRS (Numeric Rating Scale) Between Application of 10% Licocaine Spray and Placebo-for the Hand/Vessel at the Dorsum Manus and for the Forearm/Cubita. — 2.00; 1.00; 1.00; 1.00 units on a scale — p=0.398
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Volunteers are invited to undergo 4 insertions of a peripheral intra-venous 18-gauge catheter (PIVC); 2 insertions at the the start of the study on the plantar side of the hand/vessel at the dorsum manus, 2 insertions after 2-10 hours into the forearm/cubita with and without application of a 10-% lidocaine spray (5 hubs of xylocaine 10%-pump spray; AstraZeneca BV, Zoetermeer, The Netherlands) prior to the insertion of the PIVC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Difference Caused by PIVC (Peripheral Intravenous Catheter) Rated by NRS (Numeric Rating Scale) Between Application of 10% Licocaine Spray and Placebo-for the Hand/Vessel at the Dorsum Manus and for the Forearm/Cubita. |
2.00; 1.00; 1.00; 1.00 | 0.398 |
| SECONDARY Pain Caused by PIVC (Peripheral Intravenous Catheter) in the Dominant Versus Non-dominant Arm. |
1.50; 1.50; 1.00; 1.00; 2.00; 1.00 | 0.603 |
| SECONDARY Pain Caused by PIVC (Peripheral Intravenous Catheter) at the Hand/Vessel at the Dorsum Manus Versus at the Forearm/Cubita |
2.00; 1.00; 1.00; 1.00 | <0.001 sig |
| SECONDARY Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) and the Anticipated Pain. |
2; 2; 1; 1 | 0.032 sig |
| SECONDARY Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) and the Anticipated Difficulty Rated by the Operator to Insert the PIVC. |
2; 2; 1; 1 | >0.999 |
| SECONDARY Pain Caused by PIVC (Peripheral Intravenous Catheter) Between Success and Failure of Insertion of PIVC. |
2; 1; 1; 1; 4.5; 2 | — |
| SECONDARY Success Rate of Venipuncture Between Hand and Forearm. |
37; 37; 37; 37; 3; 3 | >0.999 |
| SECONDARY Correlation Between Pain Caused by PIVC (Peripheral Intravenous Catheter) Rated by NRS and PCS (Pain Catastrophizing Scale). |
2.00; 1.00; 1.00; 1.00; 8; 8 | 0.165 |
Eligibility Criteria
Inclusion Criteria
- Female probands 18-45 years
- Personal history of ever having a venipuncture or insertion of PIVC
Exclusion Criteria
- 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
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT06354816). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.