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N/A N=70 Randomized Other

Needle-Guided vs Free-Hand Technique in Performing Brachial Plexus Blockade

Needle Guidance; Nerve Blocks

Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Needle Time; — 106; 197 seconds

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Civco Needle Guidance Device (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Montefiore Medical Center
Primary completion
Jun 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Needle Time;
106; 197
SECONDARY
Nerve Block Procedure Time
86; 126

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02380183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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