Knee InjuryNCT02649322
Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy
A study testing J-Tip and Syringe and 25 gauge needle in people with Knee Injury, run by Orlando Health, Inc. at 1 site in United States.
Trial summary
Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic knee surgery compared to femoral nerve block… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Knee Injury
- What is being tested?
- J-Tip and Syringe and 25 gauge needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2015to 28 Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery.
- Able to independently complete the Visual Analog pain scales.
- Subjects who are neurologically intact at area of injection.
- English speaking.
Who cannot join
- Subjects with known allergies to lidocaine.
- Presence of developmental delay.
- Subjects with blood disorders affecting coagulation.
- Subjects on blood thinners.
- Subjects receiving chemotherapeutic agents.
- Those who use or receive analgesia prior to procedure, except for acetaminophen or Non-steroidal anti-inflammatory medications.
Show all 9Show fewer
- Any other local sedation at the area of nerve block injection.
- Non-English Speaking
- Subjects with signs of skin infection or pathology at the injection site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy.
Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected lidocaine prior to regional and general anesthesia.
Read the detailed description
The J-tip device has not been reported for use prior to regional block anesthesia prior to femoral or sciatic nerve blocks. The use of the J-tip device for lidocaine introduction prior to femoral or sciatic blocks at Arnold Palmer Medical Center has been up to the discretion of the anesthesiologist. It has been anecdotally reported at our institution to have equal or better pain relief for the regional nerve blocks as needle introduction of lidocaine.
This study seeks to evaluate the difference in pain from local anesthetic infiltration with J-tip needleless injection device compared to needle injection by use of Visual Analog Scales.
- To evaluate efficacy of femoral nerve block after J-tip device lidocaine injection post operatively by use of Visual Analog Scales.
- To assess patient and parent satisfaction with J-tip device use by satisfaction questionnaire.
- To assess changes in post operative pain medication amounts with J-tip device use.
- Conditions
- Knee Injury
- Being tested
- J-Tip, Syringe and 25 gauge needle
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
J-TipDevice
After sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic "pop" and "hissing" sounds inherent to the J-tip injector.
Syringe and 25 gauge needleDevice
The same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure. Receives: Device: J-Tip |
| Group B | Active comparator | Participants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure. Receives: Device: Syringe and 25 gauge needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.
Pain will be assessed via the Visual Analog Scale by the patient before administration of the nerve block. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
Measured: During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block
Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale
Pain will be assess via the Visual Analog Scale by the patient after the knee arthroscopy though first post op office visit and average of one week. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
Measured: During Follow-up Assessment at an Average of 1 Week Post Op
Secondary outcomes (1)
Satisfaction Via a 0 to 10 Rating Scale at Follow up
Patients will be asked to describe how satisfied they were with the knee arthroscopy via a 0 to 10 rating scale. Patient will report on a scale of 0 to 10 what their perceived satisfaction is. 0 is no satisfaction with 10 most satisfaction.
Measured: At the follow up appointment, an average of one week after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study start3 Sep 2015
- Primary completion28 Aug 2019
- Study completion28 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee InjuryStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daryl Osbahr, Orlando Health, Inc.
- Investigators
- Daryl C Osbahr, MD, Principal investigator, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649322
- Sponsor's protocol ID
- 14.099.08
- Status last verified
- Apr 2020
- First submitted
- 13 Dec 2015
- Last updated
- 5 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy.
- ClinicalTrials.gov ID
- NCT02649322
- Acronym / sponsor ID
- 14.099.08
- Conditions
- Knee Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 3 Sep 2015 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 28 Aug 2019 (actual)
- First posted
- 7 Jan 2016 (estimated)
- Results
- Posted 28 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of this study is to investigate the pain outcomes and satisfaction of pain relief for pediatric patients receiving needleless jet-injected (J-Tip) lidocaine prior to regional anesthesia with femoral and/or sciatic nerve block and general anesthesia for arthroscopic knee surgery compared to femoral nerve block and/or sciatic nerve block with needle injected lidocaine prior to regional and general anesthesia.
Detailed description
The J-tip device has not been reported for use prior to regional block anesthesia prior to femoral or sciatic nerve blocks. The use of the J-tip device for lidocaine introduction prior to femoral or sciatic blocks at Arnold Palmer Medical Center has been up to the discretion of the anesthesiologist. It has been anecdotally reported at our institution to have equal or better pain relief for the regional nerve blocks as needle introduction of lidocaine.
This study seeks to evaluate the difference in pain from local anesthetic infiltration with J-tip needleless injection device compared to needle injection by use of Visual Analog Scales.
- To evaluate efficacy of femoral nerve block after J-tip device lidocaine injection post operatively by use of Visual Analog Scales.
- To assess patient and parent satisfaction with J-tip device use by satisfaction questionnaire.
- To assess changes in post operative pain medication amounts with J-tip device use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: J-TipParticipants in Group A will receive 0.25 mL of 1% plain lidocaine delivered by the J-tip injector at the regional block site prior to introduction of the needle for the nerve block procedure. |
| Group B | Active comparator | Device: Syringe and 25 gauge needleParticipants in Group B will receive 2 mL of 1% plain lidocaine injected by syringe and 25 gauge needle at the regional block site prior to introduction of the needle for the nerve block procedure. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects between the ages of eleven and seventeen undergoing arthroscopic knee surgery.
- Able to independently complete the Visual Analog pain scales.
- Subjects who are neurologically intact at area of injection.
- English speaking.
Key exclusion criteria (9 listed)
- Subjects with known allergies to lidocaine.
- Presence of developmental delay.
- Subjects with blood disorders affecting coagulation.
- Subjects on blood thinners.
- Subjects receiving chemotherapeutic agents.
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 |
|---|---|---|
| J-TipAfter sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic "pop" and "hissing" sounds inherent to the J-tip injector. | Device | Group A |
| Syringe and 25 gauge needleThe same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle. | Device | Group B |
Primary outcome
Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale.
Time frame: During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block
Pain will be assessed via the Visual Analog Scale by the patient before administration of the nerve block. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale
Time frame: During Follow-up Assessment at an Average of 1 Week Post Op
Pain will be assess via the Visual Analog Scale by the patient after the knee arthroscopy though first post op office visit and average of one week. Patient will report on a scale of 0 to 10 what their perceived pain is. 0 is no pain with 10 being worst pain patient ever experienced.
1 secondary outcome
Satisfaction Via a 0 to 10 Rating Scale at Follow up
Time frame: At the follow up appointment, an average of one week after the procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Knee Injury
Not yet recruiting
Stair Biomechanics and Vibration Study After ACLR
Anterior Cruciate Ligament Reconstruction (ACLR), Anterior Cruciate Ligament Injury
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
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.
Daryl C Osbahr, MD principal investigator
Orlando Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing J-Tip and Syringe and 25 gauge needle in people with Knee Injury, run by Orlando Health, Inc. at 1 site in United States.
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 4 inclusion and 9 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 5 May 2020. 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 United States. 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?
Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale. (time frame: During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block). The study lists 2 primary outcomes in all. 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 5 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.