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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04991597
• Other study ID #: LESB 001
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: September 2022
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Cold Compress Pack
Palmar aspect of forearm will have a cold compress pack placed on it.
• Room Temperature Compress Pack
Palmar aspect of forearm will have a room temperature compress pack placed on it.

Drug:
• Lidocaine Epinephrine
Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate
• Lidocaine Epinephrine
Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nicholas Bastidas

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Buffered Anesthetic Solution pH	pH of each solution will be measured using a calibrated pH probe	2 Months
Primary	Pain from Needle Insertion	Pain from needle insertion during each injection will be scored on a 0 - 10 scale by participants	2 Months
Primary	Pain from Solution Deposition	Pain from solution deposition during each injection will be scored on a 0 - 10 scale by participants	2 Months
Primary	Overall Comfort Level During Injection	Comfort level during each injection will be scored on a 0 - 10 scale by participants	2 Months
Secondary	Injection Method Preference	Participants will select which of the 4 injection methods they preferred	2 Months