Clinical trial NCT01759459: Local Anesthetics for Pain Reduction Prior to IV Line Placement
Official title: A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Local Anesthesia for Peripheral Intravenous Catheterization
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain Score Following Anesthetic Administration
timeFrame: Day 1
Secondary outcomes:
measure: Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline
timeFrame: 3 months
Other outcomes:
measure: Pain Score Following Peripheral Catheter Insertion
timeFrame: Baseline and day 1
Locations:
city: Saint Paul
country: United States
facility: United Hospital, part of Allina Health Services
state: Minnesota
Study officials:
affiliation: Allina Health Services
name: David M Gurda, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ganter-Ritz V, Speroni KG, Atherton M. A randomized double-blind study comparing intradermal anesthetic tolerability, efficacy, and cost-effectiveness of lidocaine, buffered lidocaine, and bacteriostatic normal saline for peripheral intravenous insertion. J Infus Nurs. 2012 Mar-Apr;35(2):93-9. doi: 10.1097/NAN.0b013e31824241cc.
citation: McNaughton C, Zhou C, Robert L, Storrow A, Kennedy R. A randomized, crossover comparison of injected buffered lidocaine, lidocaine cream, and no analgesia for peripheral intravenous cannula insertion. Ann Emerg Med. 2009 Aug;54(2):214-20. doi: 10.1016/j.annemergmed.2008.12.025. Epub 2009 Feb 13.
citation: Nakayama M, Munemura Y, Kanaya N, Tsuchida H, Namiki A. Efficacy of alkalinized lidocaine for reducing pain on intravenous and epidural catheterization. J Anesth. 2001;15(4):201-3. doi: 10.1007/s005400170003.
citation: Windle PE, Kwan ML, Warwick H, Sibayan A, Espiritu C, Vergara J. Comparison of bacteriostatic normal saline and lidocaine used as intradermal anesthesia for the placement of intravenous lines. J Perianesth Nurs. 2006 Aug;21(4):251-8. doi: 10.1016/j.jopan.2006.05.007.