Elective Knee Surgery
Conditions
Brief summary
An FDA-approved product, InfinitiPlus (TM), is a needle guidance system that has been recently developed to guide clinicians in performing ultrasound guided nerve blocks. This system helps the clinician to align the needle with ultrasound beam while performing an ultrasound guided nerve block. InfinitiPlus (TM) has a unique open channel design allowing efficient needle movement while having improved needle shaft and tip visualization. This is a disposable system specifically designed for improving success rate of ultrasound guided block and patient safety. This study will be done with patients having elective knee surgery and a femoral nerve block with a catheter. The nerve block procedure will be performed under ultrasound guidance to help improve safety and efficacy of the injection. InfinitiPlus (TM) has been recently developed to try to improve needle guidance in the ultrasound guided nerve block procedure. This study will determine whether femoral nerve block procedures performed under ultrasound guidance with InfinitiPlus (TM) take less time than procedures performed with ultrasound guidance and a conventional block needle. The study will also determine whether the InfinitiPlus (TM) needle reduces the number of times the clinician attempts the procedure, reduces the cost of the procedure, increases the procedure success rate, and improves ultrasound visibility of the needle. Participants will be randomly assigned to either ultrasound guidance with the InfinitiPlus (TM) needle guidance system or ultrasound guidance with a conventional block needle. After surgery, pain will be rated every 30 minutes for the first 2 hours, then every 4 hours while awake for 24 hours. 24 hours after surgery, participants will be given a survey about pain treatment satisfaction and a questionnaire about recovery.
Interventions
DEVICEInfiniti Plus needle guidance system
The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.
DEVICEConventional block needle
conventional block needle used for insertion of femoral nerve catheters.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Men or women 18-85 years old * Scheduled for elective knee surgery and expected to receive a femoral nerve block and catheter * Written informed consent
Exclusion criteria
* Contraindications to femoral block such as coagulopathy, infection at the needle insertion site and allergy to local anesthetics * Pregnancy * Preexisting neuropathy involving the surgical limb
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System | time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block Failure | start of surgery until femoral nerve block completion | Number of patients who had block failure |
| > 1 Block Attempt | from start of block procedure until block placement | Number of block attempts was collected for each patient as \> 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it. |
| Percentage of Time With Perfect Needle Visibility | From start of block procedure until block placement | Percentage of time that perfect needle visibility was visualized on ultrasound. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infiniti Plus Needle Guidance System ultrasound guidance with the InfinitiPlus (TM) needle guidance system
Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks. | 67 |
| Conventional Block Needle ultrasound guidance with a conventional block needle
Conventional block needle: conventional block needle used for insertion of femoral nerve catheters. | 67 |
| Total | 134 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Never received a block. | 1 | 0 |
Baseline characteristics
| Characteristic | Infiniti Plus Needle Guidance System | Conventional Block Needle | Total |
|---|---|---|---|
| Age, Continuous | 64.7 years STANDARD_DEVIATION 10.6 | 63.8 years STANDARD_DEVIATION 9.1 | 64.3 years STANDARD_DEVIATION 12.6 |
| Intraoperative management strategy General anesthesia | 42 Participants | 36 Participants | 78 Participants |
| Intraoperative management strategy Other | 2 Participants | 0 Participants | 2 Participants |
| Intraoperative management strategy Spinal anesthesia | 23 Participants | 31 Participants | 54 Participants |
| Sex: Female, Male Female | 37 Participants | 44 Participants | 81 Participants |
| Sex: Female, Male Male | 30 Participants | 23 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 67 |
| serious Total, serious adverse events | 0 / 67 | 0 / 67 |
Outcome results
Primary
Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System
Time frame: time elapsed from beginning the block procedure (after prepping and draping) until the catheter was successfully inserted or the end of the day of surgery.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Infiniti Plus Needle Guidance System | Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System | 118 seconds |
| Conventional Block Needle | Time Spent in Performing Ultrasound Guided Femoral Nerve Blocks With InfinitiPlusTM Needle Guidance System | 177 seconds |
p-value: <0.00195% CI: [0.61, 0.76]Regression, Linear
Secondary
> 1 Block Attempt
Number of block attempts was collected for each patient as \> 1 block attempt versus 1 attempt. A block attempt was defined as pulling the block needle back to skin and redirecting it.
Time frame: from start of block procedure until block placement
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infiniti Plus Needle Guidance System | > 1 Block Attempt | 1 Participants |
| Conventional Block Needle | > 1 Block Attempt | 7 Participants |
p-value: 0.0698.3% CI: [0.01, 1.78]Regression, Logistic
Secondary
Block Failure
Number of patients who had block failure
Time frame: start of surgery until femoral nerve block completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Infiniti Plus Needle Guidance System | Block Failure | 5 Participants |
| Conventional Block Needle | Block Failure | 3 Participants |
p-value: 0.5698.3% CI: [0.25, 9.6]Regression, Logistic
Secondary
Percentage of Time With Perfect Needle Visibility
Percentage of time that perfect needle visibility was visualized on ultrasound.
Time frame: From start of block procedure until block placement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infiniti Plus Needle Guidance System | Percentage of Time With Perfect Needle Visibility | 59 percentage of time | Standard Deviation 28 |
| Conventional Block Needle | Percentage of Time With Perfect Needle Visibility | 55 percentage of time | Standard Deviation 24 |
p-value: 0.7498.3% CI: [-7.7, 14.6]Regression, Linear