Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/14/2019 |
| Start Date: | October 2014 |
| End Date: | June 2015 |
A Randomized Controlled Study Comparing Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade
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.
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.
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)
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)
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
We found this trial at
1
site
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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