Local Anesthetics for Pain Reduction Prior to IV Line Placement

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759459
• Other study ID #: 3867-1
• Status: Completed
• Phase: Phase 4
• Start date: January 2013
• Est. completion date: June 2013

Study information

• Verified date: July 2022
• Source: Allina Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthesia for Peripheral Intravenous Catheterization
• Pain

Intervention

Drug:
• Lidocaine
The medication will be administered immediately prior to receiving peripheral IV catheter placement
• Buffered Lidocaine
The medication will be administered immediately prior to receiving peripheral IV catheter placement
• Bacteriostatic Normal Saline
The medication will be administered immediately prior to receiving peripheral IV catheter placement

Locations

Country	Name	City	State
United States	United Hospital, part of Allina Health Services	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Allina Health System

Country where clinical trial is conducted

United States, 

References & Publications (10)

Beck RM, Zbierajewski FJ, Barber MK, Engoren M, Thomas R. A comparison of the pain perceived during intravenous catheter insertion after injection with various local anesthetics. AANA J. 2011 Aug;79(4 Suppl):S58-61. — View Citation

Brown D. Local anesthesia for vein cannulation: a comparison of two solutions. J Infus Nurs. 2004 Mar-Apr;27(2):85-8. — View Citation

Burke SD, Vercler SJ, Bye RO, Desmond PC, Rees YW. Local anesthesia before IV catheterization. Am J Nurs. 2011 Feb;111(2):40-5; quiz 46-7. doi: 10.1097/01.NAJ.0000394291.40330.3c. — View Citation

Carvalho B, Fuller A, Brummel C, Cohen SE. Local infiltration of epinephrine-containing lidocaine with bicarbonate reduces superficial bleeding and pain during labor epidural catheter insertion: a randomized trial. Int J Obstet Anesth. 2007 Apr;16(2):116- — View Citation

Cornelius P, Kendall J, Meek S, Rajan R. Alkalinisation of lignocaine to reduce the pain of digital nerve blockade. J Accid Emerg Med. 1996 Sep;13(5):339-40. — View Citation

Fatovich DM, Jacobs IG. A randomized controlled trial of buffered lidocaine for local anesthetic infiltration in children and adults with simple lacerations. J Emerg Med. 1999 Mar-Apr;17(2):223-8. — View 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. — View 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.a — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Score Following Peripheral Catheter Insertion	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.	Baseline and day 1
Primary	Pain Score Following Anesthetic Administration	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.	Day 1
Secondary	Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline	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.	3 months