Local Anesthetics for Pain Reduction Prior to IV Line Placement

Allina Health System

Status and phase: Completed; Phase 4

Conditions: Local Anesthesia for Peripheral Intravenous Catheterization; Pain

Treatments: Drug: Bacteriostatic Normal Saline; Drug: Buffered Lidocaine; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT01759459

3867-1

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Lidocaine

Experimental group

Description:

1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm

Treatment:

Drug: Lidocaine

Buffered Lidocaine

Experimental group

Description:

1% Buffered Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Buffered lidocaine is compounded by the following process: 2.3 mLs of 8.4% sodium bicarbonate is added to a vial of 1% lidocaine

Treatment:

Drug: Buffered Lidocaine

Bacteriostatic Normal Saline

Experimental group

Description:

Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm

Treatment:

Drug: Bacteriostatic Normal Saline