Hair DiseasesNCT06395545
Local Anesthesia and Electronic Injector
A study testing Electronic injector in people with Hair Diseases, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hair Diseases
- What is being tested?
- Electronic injector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2022to 31 Aug 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants who did not consent to the study enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of an Electronic Constant-speed Injector in Reducing Infusion Pain Associated With Local Infiltrative Anesthesia in a Scalp Surgery
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.
Read the detailed description
Local anesthesia (LA) is an imperative component of dermatologic surgery. It allows large procedures to be performed comfortably even in an office setting. However, if patients undergo painful anesthesia injection, this may negatively affect their overall experience regarding dermatologic procedures.
Therefore, numerous studies have been conducted on LA-related pain reduction. Buffering or warming local anesthesia, administering topical anesthesia or cooling anesthesia, and distracting patients with stimuli such as vibration or music are discussed to be helpful for relatively painless LA. Furthermore, low speed of injection is suggested as one of the methods to alleviate infusion-induced pain which refers to the pain associated with the infiltration of anesthetic fluid into the tissue. However, speed control with manual injection is challenging. Therefore, "computer-controlled local anesthetic delivery (CCLAD) devices" have been developed to inject LA into the tissues at a set speed. A computer-controlled local anesthetic delivery device aims to reduce LA-related pain through slow injection. The first CCLAD, Wand (Milestone Scientific Inc., Livingston, USA), was introduced in 1997 in dentistry. These CCLAD systems have been predominantly investigated in dentistry, but are also expected to relieve LA-related pain in various dermatological procedures. However, no objective study has been conducted about the efficacy of an electronic constant-speed injector in decreasing local anesthetic pain in dermatology.
Therefore, the investigators aimed to confirm the efficacy of an electronic constant-speed injector in pain reduction during local infiltrative anesthesia in a scalp surgery of dermatologic fields by comparing it to the conventional manual injection method.
This study was a single-blind, randomized, controlled trial. The investigators 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.
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.
Regarding the training of the participants, a short clip explaining the forthcoming procedures and related pain were introduced to the participants and the informed consents were obtained. NRS ranging from 0 (painless) to 10 (worst pain possible) was used as an objective tool for pain evaluation. Participants used a numeric rating scale (NRS) to rate their level of infusion-related pain immediately after receiving each 0.5 cc injection of local anesthesia.
Statistical analysis was performed using IBM SPSS (ver. 21.0; IBM Corp., Armonk, NY, USA). A paired-sample t-test was used to identify whether the NRS score of manual injection was higher than that of mechanical injection. Independent-sample t-test was used to assess for differences in the efficacy of injectors between sexes. P < 0.05 was considered to be statistically significant.
This study was approved by the institutional review boards of Asan Medical Center (2022-1463) and was conducted according to the principles of the Declaration of Helsinki.
- Conditions
- Hair Diseases
- Being tested
- Electronic injector
- Medical subject headings
- Hair Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic injectorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electronic injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Mar 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair DiseasesStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chong Hyun Won, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395545
- Sponsor's protocol ID
- 2022-1463
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of an Electronic Constant-speed Injector in Reducing Infusion Pain Associated With Local Infiltrative Anesthesia in a Scalp Surgery
- ClinicalTrials.gov ID
- NCT06395545
- Acronym / sponsor ID
- 2022-1463
- Conditions
- Hair Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 2 May 2024 (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.
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.
Detailed description
Local anesthesia (LA) is an imperative component of dermatologic surgery. It allows large procedures to be performed comfortably even in an office setting. However, if patients undergo painful anesthesia injection, this may negatively affect their overall experience regarding dermatologic procedures.
Therefore, numerous studies have been conducted on LA-related pain reduction. Buffering or warming local anesthesia, administering topical anesthesia or cooling anesthesia, and distracting patients with stimuli such as vibration or music are discussed to be helpful for relatively painless LA. Furthermore, low speed of injection is suggested as one of the methods to alleviate infusion-induced pain which refers to the pain associated with the infiltration of anesthetic fluid into the tissue. However, speed control with manual injection is challenging. Therefore, "computer-controlled local anesthetic delivery (CCLAD) devices" have been developed to inject LA into the tissues at a set speed. A computer-controlled local anesthetic delivery device aims to reduce LA-related pain through slow injection. The first CCLAD, Wand (Milestone Scientific Inc., Livingston, USA), was introduced in 1997 in dentistry. These CCLAD systems have been predominantly investigated in dentistry, but are also expected to relieve LA-related pain in various dermatological procedures. However, no objective study has been conducted about the efficacy of an electronic constant-speed injector in decreasing local anesthetic pain in dermatology.
Therefore, the investigators aimed to confirm the efficacy of an electronic constant-speed injector in pain reduction during local infiltrative anesthesia in a scalp surgery of dermatologic fields by comparing it to the conventional manual injection method.
This study was a single-blind, randomized, controlled trial. The investigators 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.
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.
Regarding the training of the participants, a short clip explaining the forthcoming procedures and related pain were introduced to the participants and the informed consents were obtained. NRS ranging from 0 (painless) to 10 (worst pain possible) was used as an objective tool for pain evaluation. Participants used a numeric rating scale (NRS) to rate their level of infusion-related pain immediately after receiving each 0.5 cc injection of local anesthesia.
Statistical analysis was performed using IBM SPSS (ver. 21.0; IBM Corp., Armonk, NY, USA). A paired-sample t-test was used to identify whether the NRS score of manual injection was higher than that of mechanical injection. Independent-sample t-test was used to assess for differences in the efficacy of injectors between sexes. P < 0.05 was considered to be statistically significant.
This study was approved by the institutional review boards of Asan Medical Center (2022-1463) and was conducted according to the principles of the Declaration of Helsinki.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Participants ( control and test group ) | Experimental | Device: Electronic injectorAt 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Participants who did not consent to the study enrollment
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 |
|---|---|---|
| Electronic injectorAt 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 | Participants ( control and test group ) |
Primary outcome
Numeric Rating Scale
Time frame: During the intervention
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic injector in people with Hair Diseases, run by Asan Medical Center at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numeric Rating Scale (time frame: During the intervention). 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 2 May 2024.