PainPhase 4NCT01759459
Local Anesthetics for Pain Reduction Prior to IV Line Placement
A Phase 4 study testing Lidocaine, Buffered Lidocaine and Bacteriostatic Normal Saline in people with Pain and Local Anesthesia for Peripheral Intravenous Catheterization, run by Allina Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Local Anesthesia for Peripheral Intravenous Catheterization
- What is being tested?
- Lidocaine, Buffered Lidocaine and Bacteriostatic Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
United Hospital, part of Allina Health Services
Saint Paul, Minnesota, 55102
About this study
Official title: A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization
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.
- Being tested
- Lidocaine, Buffered Lidocaine, Bacteriostatic Normal Saline
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Hospira brand 1% Lidocaine in 20 mL vial
The medication will be administered immediately prior to receiving peripheral IV catheter placement
Buffered LidocaineDrug
Also called 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
Bacteriostatic Normal SalineDrug
Also called Hospira brand Bacteriostatic Normal Saline in 10 mL vial
The medication will be administered immediately prior to receiving peripheral IV catheter placement
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | 1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm Receives: Drug: Lidocaine |
| Buffered Lidocaine | Experimental | 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 Receives: Drug: Buffered Lidocaine |
| Bacteriostatic Normal Saline | Experimental | Bacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm Receives: Drug: Bacteriostatic Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gurda, Allina Health System
- Investigators
- David M Gurda, PharmD, Principal investigator, Allina Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759459
- Sponsor's protocol ID
- 3867-1
- Status last verified
- Jul 2022
- First submitted
- 27 Dec 2012
- Last updated
- 15 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Beck RM, Zbierajewski FJ, Barber MK, Engoren M, Thomas R. A comparison of the pain perceived during intravenous catheter insertion after injection with various local anesthetics. AANA J. 2011 Aug;79(4 Suppl):S58-61.
PubMed 22403968Brown D. Local anesthesia for vein cannulation: a comparison of two solutions. J Infus Nurs. 2004 Mar-Apr;27(2):85-8. doi: 10.1097/00129804-200403000-00004.
PubMed 15085035Carvalho B, Fuller A, Brummel C, Cohen SE. Local infiltration of epinephrine-containing lidocaine with bicarbonate reduces superficial bleeding and pain during labor epidural catheter insertion: a randomized trial. Int J Obstet Anesth. 2007 Apr;16(2):116-21. doi: 10.1016/j.ijoa.2006.09.006. Epub 2007 Feb 5.
PubMed 17276670Cornelius P, Kendall J, Meek S, Rajan R. Alkalinisation of lignocaine to reduce the pain of digital nerve blockade. J Accid Emerg Med. 1996 Sep;13(5):339-40. doi: 10.1136/emj.13.5.339.
PubMed 8894861Burke SD, Vercler SJ, Bye RO, Desmond PC, Rees YW. Local anesthesia before IV catheterization. Am J Nurs. 2011 Feb;111(2):40-5; quiz 46-7. doi: 10.1097/01.NAJ.0000394291.40330.3c.
PubMed 21270583Fatovich DM, Jacobs IG. A randomized controlled trial of buffered lidocaine for local anesthetic infiltration in children and adults with simple lacerations. J Emerg Med. 1999 Mar-Apr;17(2):223-8. doi: 10.1016/s0736-4679(98)00157-7.
PubMed 10195475Ganter-Ritz V, Speroni KG, Atherton M. A randomized double-blind study comparing intradermal anesthetic tolerability, efficacy, and cost-effectiveness of lidocaine, buffered lidocaine, and bacteriostatic normal saline for peripheral intravenous insertion. J Infus Nurs. 2012 Mar-Apr;35(2):93-9. doi: 10.1097/NAN.0b013e31824241cc.
PubMed 22382793McNaughton C, Zhou C, Robert L, Storrow A, Kennedy R. A randomized, crossover comparison of injected buffered lidocaine, lidocaine cream, and no analgesia for peripheral intravenous cannula insertion. Ann Emerg Med. 2009 Aug;54(2):214-20. doi: 10.1016/j.annemergmed.2008.12.025. Epub 2009 Feb 13.
PubMed 19217695Nakayama M, Munemura Y, Kanaya N, Tsuchida H, Namiki A. Efficacy of alkalinized lidocaine for reducing pain on intravenous and epidural catheterization. J Anesth. 2001;15(4):201-3. doi: 10.1007/s005400170003.
PubMed 14569436Windle PE, Kwan ML, Warwick H, Sibayan A, Espiritu C, Vergara J. Comparison of bacteriostatic normal saline and lidocaine used as intradermal anesthesia for the placement of intravenous lines. J Perianesth Nurs. 2006 Aug;21(4):251-8. doi: 10.1016/j.jopan.2006.05.007.
PubMed 16935736
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Lidocaine, Buffered Lidocaine, and Bacteriostatic Normal Saline for Local Anesthesia Prior to Peripheral Intravenous Catheterization
- ClinicalTrials.gov ID
- NCT01759459
- Acronym / sponsor ID
- 3867-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 15 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: Lidocaine1% Lidocaine for injection, 0.50 mL administered one time intradermally in peripheral forearm |
| Buffered Lidocaine | Experimental | Drug: Buffered Lidocaine1% 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 |
| Bacteriostatic Normal Saline | Experimental | Drug: Bacteriostatic Normal SalineBacteriostatic Normal Saline for injection, 0.50 mL administered one time intradermally in peripheral forearm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: Hospira brand 1% Lidocaine in 20 mL vialThe medication will be administered immediately prior to receiving peripheral IV catheter placement | Drug | Lidocaine |
| Buffered LidocaineAlso: Hospira brand 1% Lidocaine in 20 mL vial, Hospira brand 8.4% sodium bicarbonate in 50 mL vialThe medication will be administered immediately prior to receiving peripheral IV catheter placement | Drug | Buffered Lidocaine |
| Bacteriostatic Normal SalineAlso: Hospira brand Bacteriostatic Normal Saline in 10 mL vialThe medication will be administered immediately prior to receiving peripheral IV catheter placement | Drug | Bacteriostatic Normal Saline |
Primary outcome
Pain Score Following Anesthetic Administration
Time frame: 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.
1 secondary outcome
Economic Analysis of Cost of Compounding Buffered Lidocaine Versus Cost of Purchasing Regular Lidocaine and/or Bacteriostatic Normal Saline
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22403968Beck RM, Zbierajewski FJ, Barber MK, Engoren M, Thomas R. A comparison of the pain perceived during intravenous catheter insertion after injection with various local anesthetics. AANA J. 2011 Aug;79(4 Suppl):S58-61.
- Results publication: PubMed 15085035Brown D. Local anesthesia for vein cannulation: a comparison of two solutions. J Infus Nurs. 2004 Mar-Apr;27(2):85-8. doi: 10.1097/00129804-200403000-00004.
- Results publication: PubMed 17276670Carvalho B, Fuller A, Brummel C, Cohen SE. Local infiltration of epinephrine-containing lidocaine with bicarbonate reduces superficial bleeding and pain during labor epidural catheter insertion: a randomized trial. Int J Obstet Anesth. 2007 Apr;16(2):116-21. doi: 10.1016/j.ijoa.2006.09.006. Epub 2007 Feb 5.
- Results publication: PubMed 8894861Cornelius P, Kendall J, Meek S, Rajan R. Alkalinisation of lignocaine to reduce the pain of digital nerve blockade. J Accid Emerg Med. 1996 Sep;13(5):339-40. doi: 10.1136/emj.13.5.339.
- Results publication: PubMed 21270583Burke SD, Vercler SJ, Bye RO, Desmond PC, Rees YW. Local anesthesia before IV catheterization. Am J Nurs. 2011 Feb;111(2):40-5; quiz 46-7. doi: 10.1097/01.NAJ.0000394291.40330.3c.
- Results publication: PubMed 10195475Fatovich DM, Jacobs IG. A randomized controlled trial of buffered lidocaine for local anesthetic infiltration in children and adults with simple lacerations. J Emerg Med. 1999 Mar-Apr;17(2):223-8. doi: 10.1016/s0736-4679(98)00157-7.
- Results publication: PubMed 22382793Ganter-Ritz V, Speroni KG, Atherton M. A randomized double-blind study comparing intradermal anesthetic tolerability, efficacy, and cost-effectiveness of lidocaine, buffered lidocaine, and bacteriostatic normal saline for peripheral intravenous insertion. J Infus Nurs. 2012 Mar-Apr;35(2):93-9. doi: 10.1097/NAN.0b013e31824241cc.
- Results publication: PubMed 19217695McNaughton C, Zhou C, Robert L, Storrow A, Kennedy R. A randomized, crossover comparison of injected buffered lidocaine, lidocaine cream, and no analgesia for peripheral intravenous cannula insertion. Ann Emerg Med. 2009 Aug;54(2):214-20. doi: 10.1016/j.annemergmed.2008.12.025. Epub 2009 Feb 13.
- Results publication: PubMed 14569436Nakayama M, Munemura Y, Kanaya N, Tsuchida H, Namiki A. Efficacy of alkalinized lidocaine for reducing pain on intravenous and epidural catheterization. J Anesth. 2001;15(4):201-3. doi: 10.1007/s005400170003.
- Results publication: PubMed 16935736Windle PE, Kwan ML, Warwick H, Sibayan A, Espiritu C, Vergara J. Comparison of bacteriostatic normal saline and lidocaine used as intradermal anesthesia for the placement of intravenous lines. J Perianesth Nurs. 2006 Aug;21(4):251-8. doi: 10.1016/j.jopan.2006.05.007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Gurda, PharmD principal investigator
Allina Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine, Buffered Lidocaine and Bacteriostatic Normal Saline in people with Pain and Local Anesthesia for Peripheral Intravenous Catheterization, run by Allina Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score Following Anesthetic Administration (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01759459, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.