Peripheral Nerve Blocks
Conditions
Keywords
Computer Assisted Instrument Guidance (CAIG), Peripheral Nerve Block, Clear Guide ONE, Needle path, Needle Guidance, Ultrasound
Brief summary
The objective of this research is to determine if the addition of the Clear Guide ONE, a Computer Assisted Instrument Guidance (CAIG) system, provides improvement over existing ultrasound guided, needle-based procedures for peripheral nerve blocks. The ultrasound can visualize the targeted vessel or nerve, but the addition of the CAIG may help the clinician better guide the needle to the target.
Detailed description
This pilot study will be a randomized, single-blinded control trial. The clinicians cannot be blinded, but the person questioning the patient post-op to determine success rate will be blinded. There will be two randomized groups of patients: control and test. The control group will receive the procedure with traditional methods and equipment currently in use at Cooper University. The test group will receive the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Interventions
DEVICEPeripheral Nerve Blocks with CAIG
The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure.
Sponsors
The Cooper Health System
Clear Guide Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing orthopedic surgery who are candidates for peripheral nerve blocks for control of postoperative pain * Able to give written informed consent
Exclusion criteria
* Unable to give informed consent * Patients in whom regional anesthesia is contradicted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block | Immediately after intervention (within 2 hours) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Attempts | Immediately following intervention (within 2 hours) | Number of instrument pricks before target is reached |
| Number of Times Needle Needs Repositioning | Immediately following intervention (within 2 hours) | — |
| Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire | Post-op day 1 | Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire. |
| Clinician Rating of the Device | Immediately following intervention (within 2 hours) | Clinician rates the device on a scale of 1-10. This also includes a questionnaire. |
| Incidence of Postoperative Nausea and Vomiting | During hospital stay (maximum 3 days) | Number of participants that reported postoperative nausea and vomiting |
| Undesired Muscle Weakness Measured Subjectively | During hospital stay (maximum 3 days) | Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer. |
| Number of Patients That Needed Rescue Opioids | During hospital stay (maximum 3 days) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Peripheral Nerve Block With CAIG The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.
Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure. | 13 |
| Peripheral Nerve Block Without CAIG The participants in the control group will receive the procedure with traditional ultrasound methods and equipment. | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Peripheral Nerve Block With CAIG | Peripheral Nerve Block Without CAIG | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 9 Participants | 19 Participants |
| Region of Enrollment United States | 13 participants | 14 participants | 27 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 14 |
| serious Total, serious adverse events | 0 / 13 | 0 / 14 |
Outcome results
Primary
Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block
Time frame: Immediately after intervention (within 2 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peripheral Nerve Block With CAIG | Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block | 2.606944444 Minutes | Standard Deviation 1.445017966 |
| Peripheral Nerve Block Without CAIG | Time Needed to Correctly Identify the Neural Structure(s) and Induce the Peripheral Nerve Block | 2.179761905 Minutes | Standard Deviation 0.510579467 |
Secondary
Clinician Rating of the Device
Clinician rates the device on a scale of 1-10. This also includes a questionnaire.
Time frame: Immediately following intervention (within 2 hours)
Population: Data for this outcome measure was not collected
Secondary
Incidence of Postoperative Nausea and Vomiting
Number of participants that reported postoperative nausea and vomiting
Time frame: During hospital stay (maximum 3 days)
Population: This data was not collected for 4 (out of 27) participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peripheral Nerve Block With CAIG | Incidence of Postoperative Nausea and Vomiting | 0 Participants |
| Peripheral Nerve Block Without CAIG | Incidence of Postoperative Nausea and Vomiting | 2 Participants |
Secondary
Number of Attempts
Number of instrument pricks before target is reached
Time frame: Immediately following intervention (within 2 hours)
Population: This data was not collected for 3 (out of 27) participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peripheral Nerve Block With CAIG | Number of Attempts | 1 Attempts | Standard Deviation 0 |
| Peripheral Nerve Block Without CAIG | Number of Attempts | 1 Attempts | Standard Deviation 0 |
Secondary
Number of Patients That Needed Rescue Opioids
Time frame: During hospital stay (maximum 3 days)
Population: This data was not collected for 4 (out of 27) patients
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peripheral Nerve Block With CAIG | Number of Patients That Needed Rescue Opioids | 6 Participants |
| Peripheral Nerve Block Without CAIG | Number of Patients That Needed Rescue Opioids | 5 Participants |
Secondary
Number of Times Needle Needs Repositioning
Time frame: Immediately following intervention (within 2 hours)
Population: Data for this outcome measure was not collected.
Secondary
Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire
Patient satisfaction will be recorded in the hospital or via phone on post-op day 1, on a 10-point scale (10 being most satisfied), using a questionnaire.
Time frame: Post-op day 1
Population: This data was not collected for 5 (out of 27) participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Peripheral Nerve Block With CAIG | Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire | 8.727272727 Units on a Scale | Standard Deviation 1.489356176 |
| Peripheral Nerve Block Without CAIG | Patient Satisfaction Recorded on Post-op Day 1 Using Questionnaire | 9.181818182 Units on a Scale | Standard Deviation 1.662418829 |
Secondary
Undesired Muscle Weakness Measured Subjectively
Number of participants that report undesired muscle weakness. Undesired muscle weakness will be measured subjectively - whether patient unable to ambulate and/or requiring the use of an immobilizer.
Time frame: During hospital stay (maximum 3 days)
Population: This data was not collected for 6 (out of 27) participants.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Peripheral Nerve Block With CAIG | Undesired Muscle Weakness Measured Subjectively | 2 Participants |
| Peripheral Nerve Block Without CAIG | Undesired Muscle Weakness Measured Subjectively | 1 Participants |