Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06354816
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-26
Brief Title:
VENLID The Application of a 10-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults
Sponsor:
Krankenhaus Barmherzige Schwestern Linz
Organization:
Krankenhaus Barmherzige Schwestern Linz
Study Overview
Official Title:
VENLID A Prospective Randomized Double-blind Controlled Trial on the Application of a 10-Lidocaine Spray Prior to the Insertion of a Peripheral Intra-venous Catheter in Female Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VENLID
Brief 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 handvessel at the dorsum manus 2 insertions after 2-10 hours into the forearmcubita 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
Detailed Description:
Visit schedule
Visit 1 Screening Informed consent Inclusion and exclusion criteria Medical history urine pregnancy test
Visit 2 Treatment Day1 PIVC vessel dorsum manus PIVC forearmcubita
Treatment Day 1
First volunteers will undergo insertion of PIVC into the vessel at the dorsum manus Volunteers are randomized in 4 groups volunteers serve as there own controls
2-10 hours later All volunteers will undergo insertion of PIVC into the forearmcubita volunteers serve as their own controls
Clinical investigation procedures
Lidocaine spray 10 and the placebo physiological saline solution are filled in neutral brown glas bottles with a dispenser dispensing 01ml per pulse of the dispenser by the Pharmacy of the Konventhospital Bermherzige Brüder Linz The operator and the volunteers are unaware which bottle contains the 10 lidocaine and which bottle the saline solution 5 pulses of either lidocaine 10 or saline are applied to the site of the planned venipuncture plantar side of the handvessel at the dorsum manus an hourglass indicating the 2 min time is turned The tourniquet is then loosened After 2 minutes the tourniquet is tightened agained desinfection is performed another 30 sec is waited-timed by an hourglass-and the insertion of the PIVC is performed The following PIVC will be used BD Venflon Pro Safety BD Vialon Material 18G 13 x 32 mm Beckton Dickinson Therapy Helsingborg Sweden To check for success of the insertion of the PIVC 5 ml of saline is injected either way successfailure the PIVC is to be removed and the pain caused by PIVC rated by NRS is recorded A pressure bandage will be applied and the volunteer is checked for well being and discharged at the principal investigators discretion Then the same procedure is repeated on the other extremity
Description of Randomization
4 randomization groups are defined per protocol Dominant refers to the stronger handforearm
Group A dominantPlacebo - non-dominantLA
Group B non-dominantPlacebo - dominantLA
Group C non-dominantLA - dominantPlacebo
Group D dominantLA - non-dominantPlacebo
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
Randomization is performed by a standard randomization program groups are stratified by where dominant vs non-dominant extremity the first PIVC will be inserted and whether LA or placebo is used at the first PIVC insertion resulting in 4 distinct groups
No effect of order of dominantnon-dominant and placeboLA is expected and thus in the main statistical analysis see above the randomization will not be taken into account Nevertheless an additional statistical analysis will be run as sensitivity analysis where the both randomization factors will be used as control variables in an ANOVA model
Neither the subinvestigator nor the subjects will know what the content of the bottles are
The plantar side of the hand and the forearmcubita are randomized separately into the four groups ABCD Afterwards hand and arm are combined with each other
Two separate block randomizations are forseen for the plantar side of the handvessel at the dorsum manus and for forearmcubita via Software R version 422
Medication
Lidocaine spray 10 Xylocaine 10 pump spray AstraZeneca BV Zoetermeer The Netherlands and the placebo physiological saline solution NaCl 09 250ml Fresenius KABI are filled in neutral brown glass bottles with a dispenser dispensing 01ml per pulse of the dispenser by the Pharmacy of the Konventhospital Barmherzige Brüder Linz on the basis of AMG
Lidocaine spray 10 Xylocaine 10 pump spray and the placebo physiological saline solution NaCl 09 are filled in neutral brown glass bottles Four bottles abcd are prepared by the pharmacy 2 bottles each are available 2 bottles with label a and b for plantar side of handvessel at the dorsum manus and 2 bottles with label c and d for forearmcubita One of the bottles a and b is a placebo and the other one the local anaesthetic One of the bottles c and d is a placebo and the other one the local anaesthetic
The content of these bottles are only known by the Sponsor and the pharmacy
The person responsible for PIVC insertion and the volunteers are unaware which bottle contains the 10 lidocaine and which bottle the saline solution Due to the banana like smell of lidocaine the person responsible for PIVC insertion and the volunteer will wear nose clips during the procedure
Null hypothesis
There is no difference in pain with and without application of LA for the plantar side of the handvessel at the dorsum manus and the forearmcubita
Alternative hypothesis
There is a difference in pain with and without application of LA for the plantar side of the handvessel at the dorsum manus and the forearmcubita
Primary objective
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 handvessel at the dorsum manus and for the forearmcubita
Secondary objectives
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 handvessel at the dorsum manus vs at the forearmcubita
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
Statistics Pain caused by PIVC rated by NRS withwithout application of local anesthesia will be analyzed by a paired- t-test NRS is used as a continuous measure and we expect the values to be approximately normally distributed and therefore plan a parametric test Normal distribution will be investigated via Q-Q-plots If there is no normal distribution the non-parametric Wilcoxon test for paired samples will be used instead of the paired t-test For descriptive analyses mean values and standard deviations will be reported For each primary outcome plantar side of the handvessel at the dorsum manus and the forearm separate significance tests for separate null hypotheses will be calculated and no adaption of the error due to multiple testing is needed The analysis will be performed with the SPSS software SPSS 320 SPSS Inc Chicago IL
For the analysis of the secondary endpoints paired t-test independent t-tests and pearson correlation will be used If the data is not normal distributed wilcoxon test for paired samples Mann-Whitney-U test for independent samples and spearman correlation will be employed instead For analyzing the success rate a chi-squared test will be calculated for comparison of groups
Visit 1 Screening Informed consent Inclusion and exclusion criteria Medical history urine pregnancy test
Visit 2 Treatment Day1 PIVC vessel dorsum manus PIVC forearmcubita
Treatment Day 1
First volunteers will undergo insertion of PIVC into the vessel at the dorsum manus Volunteers are randomized in 4 groups volunteers serve as there own controls
2-10 hours later All volunteers will undergo insertion of PIVC into the forearmcubita volunteers serve as their own controls
Clinical investigation procedures
Lidocaine spray 10 and the placebo physiological saline solution are filled in neutral brown glas bottles with a dispenser dispensing 01ml per pulse of the dispenser by the Pharmacy of the Konventhospital Bermherzige Brüder Linz The operator and the volunteers are unaware which bottle contains the 10 lidocaine and which bottle the saline solution 5 pulses of either lidocaine 10 or saline are applied to the site of the planned venipuncture plantar side of the handvessel at the dorsum manus an hourglass indicating the 2 min time is turned The tourniquet is then loosened After 2 minutes the tourniquet is tightened agained desinfection is performed another 30 sec is waited-timed by an hourglass-and the insertion of the PIVC is performed The following PIVC will be used BD Venflon Pro Safety BD Vialon Material 18G 13 x 32 mm Beckton Dickinson Therapy Helsingborg Sweden To check for success of the insertion of the PIVC 5 ml of saline is injected either way successfailure the PIVC is to be removed and the pain caused by PIVC rated by NRS is recorded A pressure bandage will be applied and the volunteer is checked for well being and discharged at the principal investigators discretion Then the same procedure is repeated on the other extremity
Description of Randomization
4 randomization groups are defined per protocol Dominant refers to the stronger handforearm
Group A dominantPlacebo - non-dominantLA
Group B non-dominantPlacebo - dominantLA
Group C non-dominantLA - dominantPlacebo
Group D dominantLA - non-dominantPlacebo
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
Randomization is performed by a standard randomization program groups are stratified by where dominant vs non-dominant extremity the first PIVC will be inserted and whether LA or placebo is used at the first PIVC insertion resulting in 4 distinct groups
No effect of order of dominantnon-dominant and placeboLA is expected and thus in the main statistical analysis see above the randomization will not be taken into account Nevertheless an additional statistical analysis will be run as sensitivity analysis where the both randomization factors will be used as control variables in an ANOVA model
Neither the subinvestigator nor the subjects will know what the content of the bottles are
The plantar side of the hand and the forearmcubita are randomized separately into the four groups ABCD Afterwards hand and arm are combined with each other
Two separate block randomizations are forseen for the plantar side of the handvessel at the dorsum manus and for forearmcubita via Software R version 422
Medication
Lidocaine spray 10 Xylocaine 10 pump spray AstraZeneca BV Zoetermeer The Netherlands and the placebo physiological saline solution NaCl 09 250ml Fresenius KABI are filled in neutral brown glass bottles with a dispenser dispensing 01ml per pulse of the dispenser by the Pharmacy of the Konventhospital Barmherzige Brüder Linz on the basis of AMG
Lidocaine spray 10 Xylocaine 10 pump spray and the placebo physiological saline solution NaCl 09 are filled in neutral brown glass bottles Four bottles abcd are prepared by the pharmacy 2 bottles each are available 2 bottles with label a and b for plantar side of handvessel at the dorsum manus and 2 bottles with label c and d for forearmcubita One of the bottles a and b is a placebo and the other one the local anaesthetic One of the bottles c and d is a placebo and the other one the local anaesthetic
The content of these bottles are only known by the Sponsor and the pharmacy
The person responsible for PIVC insertion and the volunteers are unaware which bottle contains the 10 lidocaine and which bottle the saline solution Due to the banana like smell of lidocaine the person responsible for PIVC insertion and the volunteer will wear nose clips during the procedure
Null hypothesis
There is no difference in pain with and without application of LA for the plantar side of the handvessel at the dorsum manus and the forearmcubita
Alternative hypothesis
There is a difference in pain with and without application of LA for the plantar side of the handvessel at the dorsum manus and the forearmcubita
Primary objective
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 handvessel at the dorsum manus and for the forearmcubita
Secondary objectives
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 handvessel at the dorsum manus vs at the forearmcubita
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
Statistics Pain caused by PIVC rated by NRS withwithout application of local anesthesia will be analyzed by a paired- t-test NRS is used as a continuous measure and we expect the values to be approximately normally distributed and therefore plan a parametric test Normal distribution will be investigated via Q-Q-plots If there is no normal distribution the non-parametric Wilcoxon test for paired samples will be used instead of the paired t-test For descriptive analyses mean values and standard deviations will be reported For each primary outcome plantar side of the handvessel at the dorsum manus and the forearm separate significance tests for separate null hypotheses will be calculated and no adaption of the error due to multiple testing is needed The analysis will be performed with the SPSS software SPSS 320 SPSS Inc Chicago IL
For the analysis of the secondary endpoints paired t-test independent t-tests and pearson correlation will be used If the data is not normal distributed wilcoxon test for paired samples Mann-Whitney-U test for independent samples and spearman correlation will be employed instead For analyzing the success rate a chi-squared test will be calculated for comparison of groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None