Knee Injury
Conditions
Brief 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 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.
Interventions
DEVICEJ-Tip
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.
DEVICESyringe and 25 gauge needle
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.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale. | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Via a 0 to 10 Rating Scale at Follow up | At the follow up appointment, an average of one week after the procedure. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A Lidocaine J-Tip 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.
J-Tip: 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. | 58 |
| Group B Lidocaine Syringe 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.
Syringe and 25 gauge needle: 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. | 57 |
| Total | 115 |
Baseline characteristics
| Characteristic | Group A Lidocaine J-Tip | Group B Lidocaine Syringe | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 58 Participants | 57 Participants | 115 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15 years | 14 years | 15 years |
| Participants | 58 Participants | 57 Participants | 115 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 9 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 24 Participants | 23 Participants | 47 Participants |
| Race (NIH/OMB) White | 25 Participants | 24 Participants | 49 Participants |
| Region of Enrollment United States | 58 participants | 57 participants | 115 participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 61 Participants |
| Sex: Female, Male Male | 29 Participants | 25 Participants | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 57 |
| other Total, other adverse events | 0 / 58 | 0 / 57 |
| serious Total, serious adverse events | 0 / 58 | 0 / 57 |
Outcome results
Primary
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.
Time frame: During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block
Population: Comparison of the mean pain on visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A Lidocaine J-Tip | Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale. | .25 score on a scale | Standard Deviation 1.243 |
| Group B Lidocaine Syringe | Baseline Pain Assessment Before Knee Arthroscopy Via the Visual Analog Scale. | .43 score on a scale | Standard Deviation 1.185 |
Primary
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.
Time frame: During Follow-up Assessment at an Average of 1 Week Post Op
Population: Comparison of the mean pain on visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A Lidocaine J-Tip | Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale | 1.54 units on a scale | Standard Deviation 1.524 |
| Group B Lidocaine Syringe | Pain Assessment After Knee Arthroscopy Via the Visual Analog Scale | 3.57 units on a scale | Standard Deviation 2.133 |
Secondary
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.
Time frame: At the follow up appointment, an average of one week after the procedure.
Population: Comparison of the mean satisfaction on visual analog scale
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A Lidocaine J-Tip | Satisfaction Via a 0 to 10 Rating Scale at Follow up | 2.384615385 score on a scale | Standard Deviation 1.796149728 |
| Group B Lidocaine Syringe | Satisfaction Via a 0 to 10 Rating Scale at Follow up | 2.391304348 score on a scale | Standard Deviation 2.623999904 |