Clincosm LogoSign in Get a demo

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

Sponsor
Nicholas Bastidas (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04991597
Collaborator
(none)
50
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Cold Compress Pack
  • Other: Room Temperature Compress Pack
  • Drug: Lidocaine Epinephrine
  • Drug: Lidocaine Epinephrine
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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 (Participant)
Masking Description:
Participants will be blind to the solution ratio of each injection, injector will not be blind to solution to ensure safety.
Primary Purpose:
Other
Official Title:
The Effects of Injection Site Cooling and Solution Buffering on Perceived Pain During Local Anesthesia Administration
Anticipated Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Left Forearm Injection Sites Cooled, Right Forearm Injection Sites at Room Temperature

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.

Other: Cold Compress Pack
Palmar aspect of forearm will have a cold compress pack placed on it.

Other: 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
Other Names:
  • Lidocaine Epinephrine buffered with Sodium Bicarbonate

    • Drug: Lidocaine Epinephrine
    Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate
    Other Names:
  • Lidocaine Epinephrine buffered with Sodium Bicarbonate

    		•
    Experimental: Right Forearm Injection Sites Cooled, Left Forearm Injection Sites at Room Temperature

    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.

    Other: Cold Compress Pack
    Palmar aspect of forearm will have a cold compress pack placed on it.

    Other: 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
    Other Names:
  • Lidocaine Epinephrine buffered with Sodium Bicarbonate

    • Drug: Lidocaine Epinephrine
    Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate
    Other Names:
  • Lidocaine Epinephrine buffered with Sodium Bicarbonate

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pain from Needle Insertion [2 Months]

      Pain from needle insertion during each injection will be scored on a 0 - 10 scale by participants

    2. Pain from Solution Deposition [2 Months]

      Pain from solution deposition during each injection will be scored on a 0 - 10 scale by participants

    3. Overall Comfort Level During Injection [2 Months]

      Comfort level during each injection will be scored on a 0 - 10 scale by participants

    Secondary Outcome Measures

    1. Injection Method Preference [2 Months]

      Participants will select which of the 4 injection methods they preferred

    Other Outcome Measures

    1. Buffered Anesthetic Solution pH [2 Months]

      pH of each solution will be measured using a calibrated pH probe

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Nicholas Bastidas

    Investigators

    • Principal Investigator: Nicholas Bastidas, MD, Northwell Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicholas Bastidas, Associate Professor of Plastic Surgery, Northwell Health
    ClinicalTrials.gov Identifier:
    NCT04991597
    Other Study ID Numbers:
    • LESB 001
    First Posted:
    Aug 5, 2021
    Last Update Posted:
    Aug 5, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Nicholas Bastidas, Associate Professor of Plastic Surgery, Northwell Health
    Local Anesthesia
    Lidocaine
    Bicarbonate
    Pain
    Buffering
    Injection Site Cooling
    Additional relevant MeSH terms:
    Lidocaine
    Epinephrine
    Racepinephrine
    Epinephryl borate

    Study Results

    No Results Posted as of Aug 5, 2021