Volunteer Informed Consent Document

Title: The Regional Anesthesia Study Center of Iowa (RASCI) Workshop

  • Live demonstration of the following anesthetic procedures
  • Interscalene and cervical paravetebral block and/or catheterizations
  • Infraclavicular and axillary blocks and/or catheterizations

Instructors: Andre Boezaart, MD (course director)
Robert Koorn, MD, Richard Rosenquist, MD, David Brown, MD,
Timothy Brennan, MD PhD


PURPOSE
These procedures are being performed as part of the agenda of The Regional Anesthesia Study Center of Iowa (RASCI) workshop.

I consent to allow Dr. Andre Boezaart and/or Dr. Robert Koorn and/or Dr. Richard Rosenquist and/or Dr. David Brown and/or Dr. Timothy Brennan to perform the regional anesthesia block procedures listed in the “title” above on me for instructional purposes. The Department of Anesthesia is providing this live demonstration because it is considered to be the most beneficial and useful way to instruct the attendees in the methods and mechanics of this type of anesthetic procedure.

PROCEDURES
I will undergo a routine pre-anesthetic evaluation prior to the procedure. I will be required to not eat anything on the day of my procedure. Free oral clear fluids are allowed until 2 hours prior to the scheduled time of my procedure. I will have an intravenous catheter inserted and IV fluids administered prior to the procedure. During the procedure I will be monitored with routine monitors including EKG, blood pressure and pulse oximeter. I will also be monitored by an anesthesiologist in addition to the instructing physicians listed above during the procedure and recovered in the usual post-anesthetic fashion prior to my discharge. If I agree to participate, my involvement will last for a maximum of 5 hours. This includes the time required to actually perform the nerve blocks and the subsequent recovery and post assessment time in the PACU.

Steps for interscalene and cervical paravetebral block and catheterizations

  • Positioning of "patient"
  • Demonstration of landmarks and superficial anatomy on the neck.
  • Fine needle “numbing up” of skin and subcutaneous tissue with 2 – 5 ml lidocaine.
  • Placement of single-injection needle with the aid of a nerve stimulator. Various muscle groups will twitch as a result of this. This should not be painful or uncomfortable.
  • Placement of catheter through needle with the aid of a nerve stimulator. Various muscle groups will twitch as a result of this. This should not be painful or uncomfortable.
  • Injection of a small volume (less than 5 ml) of saline through needle or catheter.
  • Subcutaneous tunneling of catheter in previously anesthetized area.
  • Removal of needle or catheter.
  • Sterile dressing of areas.

Steps for infraclavicular and axillary blocks and catheterizations

  • Positioning of “patient”
  • Demonstration of landmarks and superficial anatomy on the shoulder area.
  • Fine needle “numbing up” of skin and subcutaneous tissue with 2 – 5 ml lidocaine.
  • Placement of single-injection needle with the aid of a nerve stimulator. Various muscle groups will twitch as a result of this. This should not be painful or uncomfortable.
  • Placement of catheter through needle with the aid of a nerve stimulator. Various muscle groups will twitch as a result of this. This should not be painful or uncomfortable.
  • Injection of a small volume (less than 5 ml) of saline through needle or catheter.
  • Subcutaneous tunneling of catheter in previously anesthetized area.
  • Removal of needle or catheter.
  • Sterile dressing of areas.

RISKS
I understand that there is a negligible risk of permanent nerve damage associated with placement of a stimulating needle or catheter in close proximity to my nerves. I further understand there is a very slight risk of bleeding where the needle is inserted as well as infection and toxic side effects of the local anesthetics. Occasionally, I may have some slight discomfort of my arm muscles following the needle punctures and muscle stimulation.

COSTS AND COMPENSATION
I will not have any costs for participating in this research project.

I will be paid $400.00 for participating in the interscalene and cervical paravetebral block and/or catheterizations and infraclavicular and axillary blocks and/or catheterizations demonstrations.

VOLUNTARY PARTICIPATION
Taking part in this live demonstration is completely voluntary and is being conducted for teaching/educational purposes only. This is not intended for treatment of a medical condition.

INJURY

Payment for any medical care required for any injury incurred as a result of participating will be my responsibility (or my healthcare insurer’s).

No compensation for treatment of related injury is available from the University of Iowa unless the injury is proven to be the direct result of negligence by a University employee.

My signature indicates that this anesthetic procedure has been explained to me, that my questions have been answered, and that I agree to take part in this demonstration. By signing, I authorize Dr. Andre Boezaart and/or Dr. Robert Koorn and/or Dr. Richard Rosenquist and/or Dr. David Brown and/or Dr. Timothy Brennan to perform interscalene and cervical paravetebral block and catheterizations and infraclavicular and axillary blocks and catheterizations procedures.

INSTRUCTOR STATEMENT
I have discussed the above points with the volunteer. It is my opinion that the volunteer understands the risks, benefits, and procedures involved with participation in this anesthetic procedure.

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