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Completed

NCT Number: NCT01759459

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. 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

United Hospital, part of Allina Health Services

Saint Paul, Minnesota, 55102, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females > 18 y.o.
  • Ability to speak, read, an/or understand English
  • Ability to communicate a level of pain via the specified pain scale
  • A written order exists for an intravenous peripheral catheter insertion for the patient

Exclusion criteria

  • Lidocaine allergy
  • Buffered lidocaine allergy
  • Benzyl alcohol allergy
  • Non-English speaking
  • Non-responsive or unable to understand or report pain score (ex. intubated in the ICU)
  • Inability to place catheter

Treatment and study plan

Lidocaine

Drug

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

Other names: Hospira brand 1% Lidocaine in 20 mL vial

Buffered Lidocaine

Drug

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

Other names: Hospira brand 1% Lidocaine in 20 mL vial, Hospira brand 8.4% sodium bicarbonate in 50 mL vial

Bacteriostatic Normal Saline

Drug

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

Other names: Hospira brand Bacteriostatic Normal Saline in 10 mL vial

Primary outcomes

  1. Pain Score Following Anesthetic Administration

    Time frame: Day 1

    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.

Secondary outcomes

  1. Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline

    Time frame: 3 months

    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. The outcome data was measured and reported in a single value dollar amount per group, tallied over a 3 month period. The dollar amounts were estimated by adding up the costs of drug purchasing, technician compounding time, and pharmacist verifying time. Buffered lidocaine required both drug purchasing and compounding time, where the lidocaine and bacteriostatic normal saline required drug purchasing alone and labor costs were not taken into account.

Other outcomes

  1. Pain Score Following Peripheral Catheter Insertion

    Time frame: Baseline and day 1

    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.

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 3, 2013
Registry last updated
Jul 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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