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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: Completed Phase 4 study of Pain and Local Anesthesia for Peripheral Intravenous Catheterization, sponsored by Allina Health System.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The primary outcome measured in this study will be the level of pain reported, on a scale of 0 to 10, 0 being no pain at all and 10 being the worst pain ever felt, by the patient upon administration of the local anesthetic and upon insertion of the peripheral intravenous catheter.

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

FieldValue
Enrollment Target 150 participants
Start Date 2013-01
Est. Completion 2013-06
Phase Phase 4
Allina Health System

32 total trials

What the finished NCT01759459 record still lists

NCT01759459 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (51% lower).

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 a single indexed study location in 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.

Similar trials for Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01759459's enrollment target sits among peer trials

150 114th of 374 higher than 255 of 374 other Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01759459, the US trial registry maintained by the National Library of Medicine. NCT01759459 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.