Local Anesthesia and Electronic Injector

NCT06395545 | Completed

• 1 other identifier: 2022-1463
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

Local anesthesia-related pain is associated with injection speed. An electronic constant-speed injector was developed for slow and steady injection to alleviate dermatological anesthesia pain. The investigators aimed to validate the efficacy of an electronic constant-speed injector in reducing pain during local infiltrative anesthesia by comparing it to the conventional manual injection method. Patients who underwent local infiltrative anesthesia in an area \>5 cm during scalp surgery were selected. Each side of the surgical field was randomly assigned a manual or electronic injector for local infiltration. Each participant used the numeric rating scale (NRS) to rate infiltration-related pain on each side.

Conditions

Hair Diseases

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale

  a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

  During the intervention

Study Arms (1)

Participants ( control and test group )

EXPERIMENTAL

At room temperature, 1% lidocaine combined with 1:100,000 epinephrine was used as a local anesthesia. The electronic constant-speed injector, i-JECT® (MediHub Inc., Gyeonggi-do, Korea) (Figure 1) was used, and the injection speed of the injector was set at level 1 (0.25 mL/s) or level 2 (0.4 mL/s). The injection site in a patient was divided into two sides (left and right). The method of local infiltration (manual or using the electronic injector) was randomly assigned to each side of the surgical field, and 2.5 cc (0.5 cc at five separate areas) of local anesthetic was injected individually using a 5 cc syringe with a 31-gauge needle. All injections were administered by a single surgeon (Sung Joo Tommy Hwang) to reduce inter-operator variation.

Device: Electronic injector

Interventions

Electronic injector DEVICE

At room temperature, 1% lidocaine combined with 1:100,000 epinephrine was used as a local anesthesia. The electronic constant-speed injector, i-JECT® (MediHub Inc., Gyeonggi-do, Korea) (Figure 1) was used, and the injection speed of the injector was set at level 1 (0.25 mL/s) or level 2 (0.4 mL/s). The injection site in a patient was divided into two sides (left and right). The method of local infiltration (manual or using the electronic injector) was randomly assigned to each side of the surgical field, and 2.5 cc (0.5 cc at five separate areas) of local anesthetic was injected individually using a 5 cc syringe with a 31-gauge needle. All injections were administered by a single surgeon (Sung Joo Tommy Hwang) to reduce inter-operator variation.

Participants ( control and test group )

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who underwent local infiltrative anesthesia in an area \>5 cm during scalp surgery at Dr. Hwang's Hair Clinic, Seoul, Korea, between March 2022 and August 2022

You may not qualify if:

• Participants who did not consent to the study enrollment

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Hair Diseases

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The injection site in a patient was divided into two sides (left and right). The method of local infiltration (manual or using the electronic injector) was randomly assigned to each side of the surgical field, and 2.5 cc (0.5 cc at five separate areas) of local anesthetic was injected individually using a 5 cc syringe with a 31-gauge needle.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dermatology professor

Model Details: This study was a single-blind, randomized, controlled trial. We enrolled patients who underwent local infiltrative anesthesia in an area \>5 cm during scalp surgery at Dr. Hwang's Hair Clinic, Seoul, Korea, between March 2022 and August 2022.

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 2, 2024
• Study Start: March 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

KR (1)