Local Anesthetics for Pain Reduction Prior to IV Line Placement

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Gurda, Allina Health System
ClinicalTrials.gov Identifier:
NCT01759459
First received: December 27, 2012
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Pain
Local Anesthesia for Peripheral Intravenous Catheterization
Drug: Lidocaine
Drug: Buffered Lidocaine
Drug: Bacteriostatic Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization

Resource links provided by NLM:


Further study details as provided by Allina Health System:

Primary Outcome Measures:
  • Pain Score Following Anesthetic Administration [ Time Frame: Baseline and day 1 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Economic analysis of cost of compounding buffered lidocaine versus cost of purchasing regular lidocaine and/or bacteriostatic normal saline [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Pain Score Following Peripheral Catheter Insertion [ Time Frame: Baseline and day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 150
Study Start Date: January 2013
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidocaine
1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm
Drug: Lidocaine
The medication will be administered immediately prior to receiving peripheral IV catheter placement
Other Name: Hospira brand 1% Lidocaine in 20 mL vial
Experimental: Buffered Lidocaine

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
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
Experimental: Bacteriostatic Normal Saline
Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm
Drug: Bacteriostatic Normal Saline
The medication will be administered immediately prior to receiving peripheral IV catheter placement
Other Name: Hospira brand Bacteriostatic Normal Saline in 10 mL vial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759459

Locations
United States, Minnesota
United Hospital, part of Allina Health Services
Saint Paul, Minnesota, United States, 55102
Sponsors and Collaborators
Allina Health System
Investigators
Principal Investigator: David M Gurda, PharmD Allina Health Services
  More Information

Publications:

Responsible Party: David Gurda, Principal Investigator/PharmD, Allina Health System
ClinicalTrials.gov Identifier: NCT01759459     History of Changes
Other Study ID Numbers: 3867-1
Study First Received: December 27, 2012
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Anesthetics, Local
Lidocaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014