Skip to content

The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration

The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04991597
Enrollment
0
Registered
2021-08-05
Start date
2022-01-01
Completion date
2022-05-31
Last updated
2022-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Local Anesthesia, Lidocaine, Bicarbonate, Pain, Buffering, Injection Site Cooling

Brief 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. 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.

Interventions

OTHERCold Compress Pack

Palmar aspect of forearm will have a cold compress pack placed on it.

OTHERRoom Temperature Compress Pack

Palmar aspect of forearm will have a room temperature compress pack placed on it.

Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate

Sponsors

Nicholas Bastidas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants will be blind to the solution ratio of each injection, injector will not be blind to solution to ensure safety.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain from Needle Insertion2 MonthsPain from needle insertion during each injection will be scored on a 0 - 10 scale by participants
Pain from Solution Deposition2 MonthsPain from solution deposition during each injection will be scored on a 0 - 10 scale by participants
Overall Comfort Level During Injection2 MonthsComfort level during each injection will be scored on a 0 - 10 scale by participants

Secondary

MeasureTime frameDescription
Injection Method Preference2 MonthsParticipants will select which of the 4 injection methods they preferred

Other

MeasureTime frameDescription
Buffered Anesthetic Solution pH2 MonthspH of each solution will be measured using a calibrated pH probe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026