Needle Guidance; Nerve Blocks
Conditions
Keywords
anesthesia, nerve block, needle guidance
Brief summary
This is an openly randomized controlled parallel group study evaluating the effectiveness of using a guided approach and free-hand approach in performing upper extremity regional blocks. Potential subjects for this study are the patients who are scheduled for upper extremity surgeries requiring supraclavicular and interscalene brachial plexus blocks at Montefiore Medical Center. Rotating residents who are participating in the study will be randomly assigned either to perform block under guided approach (with the help of needle guidance) or free-hand without the needle guidance. All the blocks will be single injection blocks utilizing the in-plane technique for needle insertion which is the usual protocol in our institution. Each resident will be performing one interscalene block with the device and one without the device and one supraclavicular block with device and one without the device. An independent observer will be present during the case and will be responsible for recording the time taken to perform the block, number of times the needle has been redirected and the number of times the needle is reinserted. This observer will also administer the satisfaction questionnaire. Number of time needle is redirected and number of times reinserted is also a self reported assessment by the physician who is performing the block. Efficacy of the block will be assessed by the standard of care practiced at our center.
Detailed description
Objectives 1. The primary end point of the study is to evaluate the time taken to complete blocks with and without the use of the needle guidance device. (Start time is considered as the first skin touch by the needle until the completion of the block. Completion of the block is defined as withdrawing the needle completely out of the body). The principal investigator/co-investigator and an independent observer will be recording the time taken to complete the block. 2. Ease of the technique- (Will be assessed with a short questionnaire survey at the end of the procedure). Immediately after the block is finished, the performing physician will be requested to fill out the questionnaire. 3. Number of times needle needs to be re-directed. This is self a reported measurement. The person performing the block, investigators (attending physician) and an independent observer will be recording number of times the needle was manipulated. 4. Number of times needle was pulled out entirely out of the body and reinserted. This is also a self reported measurement. 5. Efficacy of the blocks performed will be assessed (This is part of the routine standard of care assessing the blocks.) 6. Total amount of time taken to complete the whole procedure (Starting from the first time the ultrasound probe was placed on the patient to the withdrawal of the needle after completing the procedure)
Interventions
DEVICECivco Needle Guidance Device
Needle guidance device will be used while nerve block is performed.
Sponsors
CIVCO Medical Solutions
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years old * ASA 1-3 for upper extremity surgery receiving interscalene or supraclavicular blockade * Able to understand and sign the informed consent
Exclusion criteria
* Patient refusal of regional anesthesia * Any contraindications to regional anesthesia * Any anatomical or neurological disorders (also applicable to the diagnosis made by the anesthesiologist prior to randomization of the patient) * Any other condition /diagnosis by the anesthesiologist that could compromise performing the block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Needle Time; | Needle insertion to needle withdrawal, up to 20 minutes | needle insertion to needle withdrawal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nerve Block Procedure Time | time from ultrasound contact with skin to needle withdrawal, up to 20 minutes | How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Civco needle guidance device will be used while the nerve block is performed.
Civco Needle Guidance Device: Needle guidance device will be used while nerve block is performed. | 36 |
| Standard of Care Needle guidance device will not be used while nerve block is performed; nerve block is performed by hand alone. | 34 |
| Total | 70 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Intervention |
|---|---|---|---|
| Age, Continuous | 50 years | 53 years | 56 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 34 Participants | 70 Participants | 36 Participants |
| Sex: Female, Male Female | 20 Participants | 38 Participants | 18 Participants |
| Sex: Female, Male Male | 14 Participants | 32 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 |
| other Total, other adverse events | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
Primary
Needle Time;
needle insertion to needle withdrawal
Time frame: Needle insertion to needle withdrawal, up to 20 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Needle Time; | 106 seconds |
| Standard of Care | Needle Time; | 197 seconds |
Secondary
Nerve Block Procedure Time
How long the procedure takes in minutes, starting from ultrasound contact with skin to needle withdrawal.
Time frame: time from ultrasound contact with skin to needle withdrawal, up to 20 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | Nerve Block Procedure Time | 86 seconds |
| Standard of Care | Nerve Block Procedure Time | 126 seconds |