Local Anesthetics for Pain Reduction Prior to IV Line Placement

NCT01759459 | Completed Phase 4 Results

• 1 other identifier: 3867-1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Local Anesthesia for Peripheral Intravenous Catheterization

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  3 months

Other Outcomes (1)

• Pain Score Following Peripheral Catheter Insertion

  Baseline and day 1

Study Arms (3)

Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine

Buffered Lidocaine

EXPERIMENTAL

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

Drug: Buffered Lidocaine

Bacteriostatic Normal Saline

EXPERIMENTAL

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

Drug: Bacteriostatic Normal Saline

Interventions

Lidocaine DRUG

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

Also known as: Hospira brand 1% Lidocaine in 20 mL vial

Lidocaine

Buffered Lidocaine DRUG

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

Also known as: Hospira brand 1% Lidocaine in 20 mL vial, Hospira brand 8.4% sodium bicarbonate in 50 mL vial

Buffered Lidocaine

Bacteriostatic Normal Saline DRUG

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

Also known as: Hospira brand Bacteriostatic Normal Saline in 10 mL vial

Bacteriostatic Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allina Health System: lead

Study Sites (1)

United Hospital, part of Allina Health Services

Saint Paul, Minnesota, 55102, United States

Location

Related 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.

  PMID: 22403968 RESULT

• Brown D. Local anesthesia for vein cannulation: a comparison of two solutions. J Infus Nurs. 2004 Mar-Apr;27(2):85-8. doi: 10.1097/00129804-200403000-00004.

  PMID: 15085035 RESULT

• 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):116-21. doi: 10.1016/j.ijoa.2006.09.006. Epub 2007 Feb 5.

  PMID: 17276670 RESULT

• 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. doi: 10.1136/emj.13.5.339.

  PMID: 8894861 RESULT

• 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.

  PMID: 21270583 RESULT

• 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. doi: 10.1016/s0736-4679(98)00157-7.

  PMID: 10195475 RESULT

• 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.

  PMID: 22382793 RESULT

• 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.

  PMID: 19217695 RESULT

• 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.

  PMID: 14569436 RESULT

• 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.

  PMID: 16935736 RESULT

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: David Gurda
• Organization: Allina Health

david.gurda@allina.com

612-863-6566

Study Officials

• David M Gurda, PharmD

  Allina Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/PharmD

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 3, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 15, 2022
• Results First Posted: July 15, 2022

Record last verified: 2022-07

Locations

US (1)