Pain, Local Anesthesia for Peripheral Intravenous Catheterization
Conditions
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.
Interventions
DRUGLidocaine
The medication will be administered immediately prior to receiving peripheral IV catheter placement
The medication will be administered immediately prior to receiving peripheral IV catheter placement
The medication will be administered immediately prior to receiving peripheral IV catheter placement
Sponsors
Allina Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Following Anesthetic Administration | Day 1 | 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
| Measure | Time frame | Description |
|---|---|---|
| Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | 3 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Following Peripheral Catheter Insertion | Baseline and day 1 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lidocaine 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm
Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement | 50 |
| 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
Buffered Lidocaine: The medication will be administered immediately prior to receiving peripheral IV catheter placement | 50 |
| Bacteriostatic Normal Saline Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm
Bacteriostatic Normal Saline: The medication will be administered immediately prior to receiving peripheral IV catheter placement | 50 |
| Total | 150 |
Baseline characteristics
| Characteristic | Lidocaine | Buffered Lidocaine | Bacteriostatic Normal Saline | Total |
|---|---|---|---|---|
| Age, Continuous | 58.3 years | 56.6 years | 56 years | 57.5 years |
| Baseline pain scores | 0.09 units on a scale | 0.03 units on a scale | 0.15 units on a scale | 0.09 units on a scale |
| Sex: Female, Male Female | 24 Participants | 25 Participants | 29 Participants | 78 Participants |
| Sex: Female, Male Male | 26 Participants | 25 Participants | 21 Participants | 72 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lidocaine | Pain Score Following Anesthetic Administration | 2.81 units on a scale |
| Buffered Lidocaine | Pain Score Following Anesthetic Administration | 1.64 units on a scale |
| Bacteriostatic Normal Saline | Pain Score Following Anesthetic Administration | 2.05 units on a scale |
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.
Time frame: 3 months
Population: An analysis adding up the costs of drug purchasing, technician compounding time, and pharmacist verifying time, within a quarter of a year. 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lidocaine | Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | 13400 Dollars |
| Buffered Lidocaine | Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | 9100 Dollars |
| Bacteriostatic Normal Saline | Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | 4840 Dollars |
Other Pre-specified
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.
Time frame: Baseline and day 1
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lidocaine | Pain Score Following Peripheral Catheter Insertion | Average pain score following medication injection | 2.58 units on a scale |
| Lidocaine | Pain Score Following Peripheral Catheter Insertion | Average pain score following IV inserti | 1.81 units on a scale |
| Buffered Lidocaine | Pain Score Following Peripheral Catheter Insertion | Average pain score following medication injection | 1.6 units on a scale |
| Buffered Lidocaine | Pain Score Following Peripheral Catheter Insertion | Average pain score following IV inserti | 1.81 units on a scale |
| Bacteriostatic Normal Saline | Pain Score Following Peripheral Catheter Insertion | Average pain score following medication injection | 2.10 units on a scale |
| Bacteriostatic Normal Saline | Pain Score Following Peripheral Catheter Insertion | Average pain score following IV inserti | 3.05 units on a scale |