Computer Assisted Instrument Guidance (CAIG) for Orthopedic Peripheral Nerve Blocks

Clear Guide Medical

Status: Completed

Conditions: Peripheral Nerve Blocks

Treatments: Device: Peripheral Nerve Blocks with CAIG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02614222

CGM 15-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Peripheral Nerve Block with CAIG

Experimental group

Description:

The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.

Treatment:

Device: Peripheral Nerve Blocks with CAIG

Peripheral Nerve Block without CAIG

No Intervention group

Description:

The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.