CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 150 enrolled
Drug / intervention
Lidocaine +2 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01759459
NCT01759459Phase 4Completed

A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization

Allina Health System·interventional·Posted Jan 3, 2013·Updated Jul 15, 2022

In Brief

A Phase 4 clinical trial evaluating Lidocaine, Buffered Lidocaine, and 1 other intervention for Pain and Local Anesthesia for Peripheral Intravenous Catheterization. Completed, enrolled 150 participants across 1 site.

Detailed 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 and will take into account the daily time allocated to pharmacy technicians and pharmacists for compounding and verifying buffered lidocaine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 3, 2013
Enrollment StartJan 1, 2013
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.5 years ago

Interventions

Lidocainedrug

The medication will be administered immediately prior to receiving peripheral IV catheter placement

Buffered Lidocainedrug

The medication will be administered immediately prior to receiving peripheral IV catheter placement

Bacteriostatic Normal Salinedrug

The medication will be administered immediately prior to receiving peripheral IV catheter placement