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Phase 4 Completed N=150 Randomized Double-blind Treatment

Local Anesthetics for Pain Reduction Prior to IV Line Placement

Postoperative Pain · Local Anesthesia for Peripheral Intravenous Catheterization
Source: ClinicalTrials.gov NCT01759459 ↗
Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Pain Score Following Anesthetic Administration — 2.81; 1.64; 2.05 units on a scale
◆ Published Evidence
Established
27citations · ~1 / year
Local infiltration of epinephrine-containing lidocaine with bicarbonate reduces superficial bleeding and pain during labor epidural catheter insertion: a randomized trial.
International journal of obstetric anesthesia · 2007 · High-confidence link

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.

Linked Publications (5)

  • Local infiltration of epinephrine-containing lidocaine with bicarbonate reduces superficial bleeding and pain during labor epidural catheter insertion: a randomized trial.
    International journal of obstetric anesthesia · 2007 · 27 citations · High-confidence link
  • Local anesthesia for vein cannulation: a comparison of two solutions.
    Journal of infusion nursing : the official publication of the Infusion Nurses Society · 2004 · 25 citations · High-confidence link
  • Alkalinisation of lignocaine to reduce the pain of digital nerve blockade.
    Journal of accident & emergency medicine · 1996 · 21 citations · Open access · High-confidence link
  • Local anesthesia before IV catheterization.
    The American journal of nursing · 2011 · 19 citations · High-confidence link
  • A comparison of the pain perceived during intravenous catheter insertion after injection with various local anesthetics.
    AANA journal · 2011 · 14 citations · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Score Following Anesthetic Administration
2.81; 1.64; 2.05
SECONDARY
Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline
13400; 9100; 4840

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01759459) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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