PainNCT04991597
The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration
A study testing Cold Compress Pack, Room Temperature Compress Pack and Lidocaine Epinephrine in people with Pain, run by Nicholas Bastidas.
Trial summary
Participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Cold Compress Pack, Room Temperature Compress Pack and Lidocaine Epinephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures
- Any gender, aged 21 - 65
- In good general health with no peripheral neuropathy or disorders that may produce peripheral neuropathy such as uncontrolled diabetes mellitus
- Healthy intact skin on the palmar aspect of both left and right forearms
- Fluent in English
Who cannot join
- Current use of any medication
- Pregnancy
- Known allergic reactions to components of the local anesthetic such as sulfites
- History of vasovagal response to venipuncture or vaccination
- History of trauma to the forearms i.e., bone breaks, burns, deep lacerations
- Decreased sensation to the palmar aspect of either forearm
About this study
Participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. Injection site cooling and solution buffering using a 3:1 ratio will be compared to the current standard, no injection site cooling and 9:1 solution buffering.
- Conditions
- Pain
- Being tested
- Cold Compress Pack, Room Temperature Compress Pack, Lidocaine Epinephrine
- Keywords
- Local Anesthesia, Lidocaine, Bicarbonate, Pain, Buffering, Injection Site Cooling
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Compress PackOther
Palmar aspect of forearm will have a cold compress pack placed on it.
Room Temperature Compress PackOther
Palmar aspect of forearm will have a room temperature compress pack placed on it.
Lidocaine EpinephrineDrug
Also called Lidocaine Epinephrine buffered with Sodium Bicarbonate
Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate
Lidocaine EpinephrineDrug
Also called Lidocaine Epinephrine buffered with Sodium Bicarbonate
Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate
| Study group | Role | What they receive |
|---|---|---|
| Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature | Experimental | Palmar aspect of participants left forearm will have a cold compress pack placed on it. The palmar aspect of the right forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order. Receives: Other: Cold Compress Pack; Other: Room Temperature Compress Pack; Drug: Lidocaine Epinephrine |
| Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature | Experimental | Palmar aspect of participants right forearm will have a cold compress pack placed on it. The palmar aspect of the left forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order. Receives: Other: Cold Compress Pack; Other: Room Temperature Compress Pack; Drug: Lidocaine Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain from Needle Insertion
Pain from needle insertion during each injection will be scored on a 0 - 10 scale by participants
Measured: 2 Months
Pain from Solution Deposition
Pain from solution deposition during each injection will be scored on a 0 - 10 scale by participants
Measured: 2 Months
Overall Comfort Level During Injection
Comfort level during each injection will be scored on a 0 - 10 scale by participants
Measured: 2 Months
Secondary outcomes (1)
Injection Method Preference
Participants will select which of the 4 injection methods they preferred
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jan 2022 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Why it stopped: Shift in research focus
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Palmar aspect of participants forearms will be randomized to have either a cold compress pack or a room temperature compress pack placed on it. The cold compress pack serves as the trial intervention and the room temperature compress pack serves as the placebo. Each forearm will then be injected with both a 3:1 (experimental ratio) and a 9:1 (standard ratio) mixture of lidocaine with epinephrine:sodium bicarbonate in a randomized order.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholas Bastidas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicholas Bastidas, Northwell Health
- Investigators
- Nicholas Bastidas, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991597
- Sponsor's protocol ID
- LESB 001
- Status last verified
- Sep 2022
- First submitted
- 3 Aug 2021
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration
- ClinicalTrials.gov ID
- NCT04991597
- Acronym / sponsor ID
- LESB 001
- Conditions
- Pain
- Keywords
- Local Anesthesia, Lidocaine, Bicarbonate, Pain, Buffering, Injection Site Cooling
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Shift in research focus
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nicholas BastidasUniversity, hospital or other
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will have local anesthesia administered to the palmar aspect of both forearms using 4 different injection methods in order to determine which method provides the best results in terms of perceived pain, overall comfort, and participant preference. Injection site cooling and solution buffering using a 3:1 ratio will be compared to the current standard, no injection site cooling and 9:1 solution buffering.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Palmar aspect of participants forearms will be randomized to have either a cold compress pack or a room temperature compress pack placed on it. The cold compress pack serves as the trial intervention and the room temperature compress pack serves as the placebo. Each forearm will then be injected with both a 3:1 (experimental ratio) and a 9:1 (standard ratio) mixture of lidocaine with epinephrine:sodium bicarbonate in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature | Experimental | Other: Cold Compress Pack, Other: Room Temperature Compress Pack, Drug: Lidocaine EpinephrinePalmar aspect of participants left forearm will have a cold compress pack placed on it. The palmar aspect of the right forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order. |
| Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature | Experimental | Other: Cold Compress Pack, Other: Room Temperature Compress Pack, Drug: Lidocaine EpinephrinePalmar aspect of participants right forearm will have a cold compress pack placed on it. The palmar aspect of the left forearm will have a room temperature compress pack placed on it. Each forearm will be injected with 1mL of lidocaine with epinephrine buffered with sodium bicarbonate. Each forearm will be injected once with the experimental ratio (3:1) and once with the standard control ratio (9:1). Injections will be administered in a randomized order. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures
- Any gender, aged 21 - 65
- In good general health with no peripheral neuropathy or disorders that may produce peripheral neuropathy such as uncontrolled diabetes mellitus
- Healthy intact skin on the palmar aspect of both left and right forearms
Key exclusion criteria (6 listed)
- Current use of any medication
- Pregnancy
- Known allergic reactions to components of the local anesthetic such as sulfites
- History of vasovagal response to venipuncture or vaccination
- History of trauma to the forearms i.e., bone breaks, burns, deep lacerations
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 |
|---|---|---|
| Cold Compress PackPalmar aspect of forearm will have a cold compress pack placed on it. | Other | Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature, Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature |
| Room Temperature Compress PackPalmar aspect of forearm will have a room temperature compress pack placed on it. | Other | Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature, Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature |
| Lidocaine EpinephrineAlso: Lidocaine Epinephrine buffered with Sodium BicarbonateLidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate | Drug | Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature, Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature |
| Lidocaine EpinephrineAlso: Lidocaine Epinephrine buffered with Sodium BicarbonateLidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate | Drug | Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature, Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature |
Primary outcome
Pain from Needle Insertion
Time frame: 2 Months
Pain from needle insertion during each injection will be scored on a 0 - 10 scale by participants
Pain from Solution Deposition
Time frame: 2 Months
Pain from solution deposition during each injection will be scored on a 0 - 10 scale by participants
Overall Comfort Level During Injection
Time frame: 2 Months
Comfort level during each injection will be scored on a 0 - 10 scale by participants
1 secondary outcome
Injection Method Preference
Time frame: 2 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Nicholas Bastidas, MD principal investigator
Northwell Health
Questions about this trial
What is this clinical trial studying?
A study testing Cold Compress Pack, Room Temperature Compress Pack and Lidocaine Epinephrine in people with Pain, run by Nicholas Bastidas.
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 6 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: withdrawn, as of the sponsor's last update on 21 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 from Needle Insertion (time frame: 2 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2022.