Knee Injury Clinical Trial
Official title:
Randomized, Controlled Trial of Needleless Jet Injected (J-Tip) Lidocaine in Children Undergoing Regional Anesthesia Prior to Knee Arthroscopy.
Verified date | April 2020 |
Source | Orlando Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 115 |
Est. completion date | August 28, 2019 |
Est. primary completion date | August 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 11 Years to 17 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Orlando Health | Orlando | Florida |
Lead Sponsor | Collaborator |
---|---|
Orlando Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | During Baseline Assessment, Taking Approximately 20 Minutes, Before Nerve Block | |
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. | During Follow-up Assessment at an Average of 1 Week Post Op | |
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. | At the follow up appointment, an average of one week after the procedure. |
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