An Evaluation of the Effectiveness of Local Anesthetics Used During Intravenous Catheter Insertion

NCT02162680 | Completed Phase 4 Results

• 1 other identifier: Pro00015861
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. Two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. This study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.

Conditions

IV Insertion Pain

Keywords

local anesthesia; intravenous catheter

Outcome Measures

Primary Outcomes (1)

• Differences in Patients' Perceptions of Pain Between Treatment Methods

  The visual analog pain scale is a patient-reported measure of pain on a 10-point scale with 0 being no pain and 10 being worst possible pain. The visual analog pain score will be completed at the following time points: pre injection, during injection, and during catheter insertion.

  at pre injection, during anesthetic injection, and during catheter insertion, up to approximately 1 minute

Study Arms (3)

lidocaine

ACTIVE COMPARATOR

1% lidocaine intradermal injection

Drug: 1% lidocaine

bacteriostatic normal saline (BNS)

ACTIVE COMPARATOR

bacteriostatic normal saline (BNS) injection

Drug: bacteriostatic normal saline (BNS)

no local anesthetic

NO INTERVENTION

usual care practice of no local anesthetic administration

Interventions

1% lidocaine DRUG

lidocaine

bacteriostatic normal saline (BNS) DRUG

bacteriostatic normal saline (BNS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients (aged 18 or older)
• admitted to a general medical or surgical unit at Durham Regional Hospital (DRH)
• have a physician's order for an IV
• are able to speak, read and understand English
• referred to the Vascular Access Specialty Team (VAST) at DRH for IV catheterization

You may not qualify if:

• admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units;
• history of a psychological disorder, as determined from the patient's chart;
• history of peripheral neuropathy, as determined by patient's chart;
• history of IV drug abuse, as determined from the patient's chart;
• decreased sensation in the arm or hands, as reported in the chart or by the patient;
• patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing Visual Analog Scale);
• a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart;
• veins that cannot be palpated and are difficult to visualize by VAST nurses;
• pregnancy;
• an order for the emergency insertion of an IV by the patient's doctor or assigned nurse;
• an IV insertion that requires the use of a catheter gauged 18 or larger
• severe vision impairment, as determined by the patient's inability to read the Visual Analogue Scale

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Julia Aucoin, DNS
• Organization: Duke University Medical Center

julia.aucoin@dm.duke.edu

1 919 613 6406

Study Officials

• Julia Aucoin, DNS, RN

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: March 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-06