A Phase 4 interventional study of Lidocaine and Buffered Lidocaine in Pain and Local Anesthesia for Peripheral Intravenous Catheterization, sponsored by Allina Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-15.
Sponsored by Allina Health System · Phase 4, Interventional, and Treatment
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.
Exclusion Criteria:
1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm
Drug: 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
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
Also known as: Hospira brand 1% Lidocaine in 20 mL vial
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
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
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
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
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
| Milestone | Lidocaine | Buffered Lidocaine | Bacteriostatic Normal Saline |
|---|---|---|---|
| Started | 50 | 50 | 50 |
| Completed | 50 | 50 | 50 |
| Not completed | 0 | 0 | 0 |
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.
| units on a scale | Lidocaine | Buffered Lidocaine | Bacteriostatic Normal Saline |
|---|---|---|---|
| Pain Score Following Anesthetic Administration | 2.81 (0 to 10) | 1.64 (0 to 10) | 2.05 (0 to 10) |
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.
| Dollars | Buffered Lidocaine Cost | Lidocaine Cost | Bacteriostatic Normal Saline Cost |
|---|---|---|---|
| Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline | 13400 | 9100 | 4840 |
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.
| units on a scale | Lidocaine | Buffered Lidocaine | Bacteriostatic Normal Saline |
|---|---|---|---|
| Average pain score following medication injection | 2.58 (0 to 10) | 1.6 (0 to 10) | 2.10 (0 to 10) |
| Average pain score following IV inserti | 1.81 (0 to 10) | 1.81 (0 to 10) | 3.05 (0 to 10) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lidocaine | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Buffered Lidocaine | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Bacteriostatic Normal Saline | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Lidocaine | Buffered Lidocaine | Bacteriostatic Normal Saline | Total |
|---|---|---|---|---|
| Mean | 58.3 (20 to 75) | 56.6 (20 to 75) | 56 (20 to 75) | 57.5 (20 to 75) |
| Sex: Female, Male(Participants) | Lidocaine | Buffered Lidocaine | Bacteriostatic Normal Saline | Total |
|---|---|---|---|---|
| Female | 24 | 25 | 29 | 78 |
| Male | 26 | 25 | 21 | 72 |
| Baseline pain scores(units on a scale) | Lidocaine | Buffered Lidocaine | Bacteriostatic Normal Saline | Total |
|---|---|---|---|---|
| Mean | 0.09 (0 to 10) | 0.03 (0 to 10) | 0.15 (0 to 10) | 0.09 (0 to 10) |
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Allina Health System