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NCT01759459 · ClinicalTrials.gov registry record · Phase 4
Local Anesthetics for Pain Reduction Prior to IV Line Placement
A Phase 4 study of Pain and Local Anesthesia for Peripheral Intravenous Catheterization, sponsored by Allina Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT01759459 is a Phase 4 study of Pain and Local Anesthesia for Peripheral Intravenous Catheterization that has completed, run by Allina Health System. The registered enrollment target is 150 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01759459, a Phase 4 study of Pain and Local Anesthesia for Peripheral Intravenous Catheterization, has completed, sponsored by Allina Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the pain level felt by patients when receiving placement of a peripheral intravenous catheter (IV line) following the administration of a local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and bacteriostatic normal saline. Lidocaine is commonly used as a premedication for reducing the pain upon insertion of peripheral IV lines. However, due to its acidic nature, the lidocaine itself may cause pain upon administration. To help counter this discomfort, pharmacies can "buffer" the lidocaine using sodium bicarbonate, which increases the pH to a neutral value, resulting in less pain. Bacteriostatic normal saline has also been used for local anesthesia with peripheral IV placement, particularly in patients with a lidocaine allergy, as it contains benzyl alcohol which acts as a local anesthetic. There are minimal reports from the literature that directly compare patient reported pain of all three agents to one another, although studies do exist that have compared buffered lidocaine versus lidocaine and buffered lidocaine versus bacteriostatic normal saline. To address this comparison gap, the following research questions need to be asked: which anesthetic agent is the superior premedication for reducing the amount of pain upon administration of the local anesthetic itself and for the pain associated with the peripheral insertion of the catheter? The hypothesis of the investigators is that there is not a significant difference in the degree of pain scales between the anesthetic agents to justify the pharmacoeconomic costs associated with compounding buffered lidocaine. The primary outcome measured in this study will be the level of pain reported by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter. A secondary outcome includes a pharmacoeconomic analysis that will look specifically at the cost-savings of using one agent over the other
Conditions Studied
Interventions
- DRUG Lidocaine
- DRUG Buffered Lidocaine
- DRUG Bacteriostatic Normal Saline
Study Locations (1)
Minnesota
- United Hospital, part of Allina Health Services - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01759459
The ClinicalTrials.gov registry entry for NCT01759459 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (51% lower). The listed sponsor is Allina Health System, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 3 interventions - of which Lidocaine is the first listed.
NCT01759459 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT01759459 about?
NCT01759459 is a clinical study titled "Local Anesthetics for Pain Reduction Prior to IV Line Placement". The purpose of this study is to compare the pain level felt by patients when receiving placement of a peripheral intravenous catheter (IV line) following the administration of a local anesthetic. The local anesthetics tested will be lidocaine, buffered lidocaine, and bacteriostatic normal saline. Li...
What is the current status of trial NCT01759459?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2013-01. Estimated completion is 2013-06.
What conditions does trial NCT01759459 study?
This clinical trial studies the following conditions: Pain, Local Anesthesia for Peripheral Intravenous Catheterization.
What interventions are being tested in trial NCT01759459?
The interventions under investigation include: Lidocaine (DRUG), Buffered Lidocaine (DRUG), Bacteriostatic Normal Saline (DRUG).
Who is sponsoring clinical trial NCT01759459?
This trial is sponsored by Allina Health System, which has 32 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01759459 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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