IV Insertion PainPhase 4NCT02162680
An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
A Phase 4 study testing 1% lidocaine and bacteriostatic normal saline (BNS) in people with IV Insertion Pain, run by Duke University.
Trial summary
The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IV Insertion Pain
- What is being tested?
- 1% lidocaine and bacteriostatic normal saline (BNS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients (aged 18 or older)
- admitted to a general medical or surgical unit at Durham Regional Hospital (DRH)
- have a physician's order for an IV
- are able to speak, read and understand English
- referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization
Who cannot join
- admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units;
- history of a psychological disorder, as determined from the patient's chart;
- history of peripheral neuropathy, as determined by patient's chart;
- history of IV drug abuse, as determined from the patient's chart;
- decreased sensation in the arm or hands, as reported in the chart or by the patient;
- patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing Visual Analog Scale);
Show all 12Show fewer
- a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart;
- veins that cannot be palpated and are difficult to visualize by VAST nurses;
- pregnancy;
- an order for the emergency insertion of an IV by the patient's doctor or assigned nurse;
- an IV insertion that requires the use of a catheter gauged 18 or larger
- severe vision impairment, as determined by the patient's inability to read the Visual Analogue Scale
About this study
The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.
- Conditions
- IV Insertion Pain
- Being tested
- 1% lidocaine, bacteriostatic normal saline (BNS)
- Keywords
- local anesthesia, intravenous catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% lidocaineDrug
bacteriostatic normal saline (BNS)Drug
| Study group | Role | What they receive |
|---|---|---|
| lidocaine | Active comparator | 1% lidocaine intradermal injection Receives: Drug: 1% lidocaine |
| bacteriostatic normal saline (BNS) | Active comparator | bacteriostatic normal saline (BNS) injection Receives: Drug: bacteriostatic normal saline (BNS) |
| no local anesthetic | No intervention | usual care practice of no local anesthetic administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Patients' Perceptions of Pain Between Treatment Methods
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.
Measured: at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startMar 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IV Insertion PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Aucoin, DNS, RN, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162680
- Sponsor's protocol ID
- Pro00015861
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 15 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion
- ClinicalTrials.gov ID
- NCT02162680
- Acronym / sponsor ID
- Pro00015861
- Conditions
- IV Insertion Pain
- Keywords
- local anesthesia, intravenous catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Posted 15 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lidocaine | Active comparator | Drug: 1% lidocaine1% lidocaine intradermal injection |
| bacteriostatic normal saline (BNS) | Active comparator | Drug: bacteriostatic normal saline (BNS)bacteriostatic normal saline (BNS) injection |
| no local anesthetic | No intervention | –usual care practice of no local anesthetic administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients (aged 18 or older)
- admitted to a general medical or surgical unit at Durham Regional Hospital (DRH)
- have a physician's order for an IV
- are able to speak, read and understand English
- referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization
Key exclusion criteria (12 listed)
- admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units;
- history of a psychological disorder, as determined from the patient's chart;
- history of peripheral neuropathy, as determined by patient's chart;
- history of IV drug abuse, as determined from the patient's chart;
- decreased sensation in the arm or hands, as reported in the chart or by the patient;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% lidocaine | Drug | lidocaine |
| bacteriostatic normal saline (BNS) | Drug | bacteriostatic normal saline (BNS) |
Primary outcome
Differences in Patients' Perceptions of Pain Between Treatment Methods
Time frame: at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute
The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Aucoin, DNS, RN principal investigator
Duke Health
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% lidocaine and bacteriostatic normal saline (BNS) in people with IV Insertion Pain, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Patients' Perceptions of Pain Between Treatment Methods (time frame: at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.