ORTHO ROTATION: INFORMED CONSENT

Informed consent is a process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the said procedure.  Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to his/her body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion:

1.     The nature of the procedure

2.     The risks and benefits and the procedure

3.     Reasonable alternatives

4.     Risks and benefits of alternatives

5.     An assessment of the patient's understanding of elements 1-4.

It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider. The provider must make a recommendation and provide his/her reasoning for said recommendation.

SAMPLE DOCUMENTATION: "I discussed with PATIENT NAME the risks of spinal anesthesia including but not limited to bleeding, infection, post-dural puncture headache, nerve irritation and nerve injury, failed block and need for conversion to general anesthesia. All questions were answered and the patient expressed understanding of the plan and wishes to proceed."

INFORMED CONSENT FOR SPINAL ANESTHESIA

The following is an example of informed consent for spinal anesthesia in the context of a total joint replacement. Modify it as appropriate for your patient. Remember…language and descriptions must be easily understood by the patient – avoid overly technical medical jargon!

1.     The nature of the procedure

• This is the way we normally do the anesthetic for Dr. ***

• What is a spinal? – An injection done in the back that makes you completely numb from waist down

• Assuming you don’t want to be awake for the procedure we will give you IV sedation so you are asleep during the operation.

• The procedure involves us

  • • • Going back to the operating room

      • Having you sit up on the OR table with your legs hanging over the edge (like sitting up on a park bench)

      • Getting yourself in a very specific position which helps open up the spaces in your back

      • After cleaning the back, we will numb up your skin (sometimes this can sting, just like at the dentist)

      • Then we use a small needle is then used to find the spinal space to deliver the injection

      • After the injection you will very quickly start getting numb, we help you lay down and give you an oxygen mask and then help get you off to sleep.

      • Optional: we can provide you some relaxing medicine in the IV while we are placing the spinal so you are more comfortable

2.     Risks and benefits of the procedure

Benefits

• • • Because your hip/knee is completely numb, the amount of medication needed to keep you sedated is minimal, allowing for quicker recovery. In contrast general anesthesia requires a much deeper level of sedation such that we must insert a breathing tube to assist with your breathing

    • Due to avoiding the general anesthesia – typically patients can avoid the nausea/vomiting to sometimes accompanies general anesthesia, and avoid having a breathing tube which may result in a sore throat.

    • At the end of the operation, you will typically still be numb at the surgical site – allowing you a pain free interval postoperatively. As the spinal slowly recedes, you are able to ask for pain medication to stay relatively comfortable

    • In several large studies, spinal anesthesia has been shown to the lower the chances of… (For a more detailed discussion please see the spinal vs general section)

      • • 1. Bleeding & blood transfusion rates

          2. Infections

          3. Blood clots and pulmonary embolism

          4. Respiratory complications

          5. Kidney failure

          6. Chance of death (I typically do not mention this one…it is probably more off-putting than helpful)

  Risks (For a more detailed discussion please see the complications of neuraxial anesthesia section)

• Bleeding

• Infection

• Headache (postdural puncture headache)

• Nerve irritation (transient neurologic syndrome, paresthesias)

• Nerve injury

• Failed block (difficulty in placing spinal, inadequate block)

  In a nervous patient, it is helpful to describe why the risks are low.

1. Bleeding: “Your bleeding risk is low because you do not have a bleeding disorder, and are not on blood thinners”

2.  Infection: “The risk of infection is low because we do the procedure sterilely much like your surgeons will perform the operation sterilely

3.  Headache: “The incidence of headache is 1/300 – 1/400 patients” (See the complications of neuraxial anesthesia section)

4. Nerve irritation/injury: it is helpful to explain to patients that we minimize this risk by performing the procedure with them awake and communicative. I usually describe a paresthesia that everyone is familiar with – hitting their funny bone – and explain that when we encounter a paresthesia we use that information to help avoid getting too near a nerve.

 “You’ve hit your funny bone before – and gotten a zing down your arm? Well if we get near a nerve back here, it is possible for you to feel something similar – but in your buttocks/leg area. If you feel that, please let us know and we will back away from that area. This is what keeps the procedure safer.”

3.     Reasonable alternatives

• General anesthesia is the alternative method of having a total joint arthroplasty. Please emphasize that despite the described benefits of spinal anesthesia that general anesthesia is a perfectly reasonable and fine alternative anesthetic. This way if the spinal is difficult to place, the patient is not too disappointed or fearful with proceeding forward with the GA.
  
  

  4.     Describe GA and its risks and benefits with the patient

         5.     Assess the patient’s understanding of what was discussed, and allow for questions.

Pro-tips

1. When introducing the spinal anesthetic emphasize that this is typically how we provide anesthesia for these types of cases. Patients usually want to go with a common and proven anesthetic. Also, assess their familiarity with neuraxial blocks – many patients have had a spinal before for prior joint replacements, and many patients are familiar with them due to prior exposure during childbirth, and some may even have undergone epidural steroid injections for back pain.

 “We typically do these procedures under a spinal anesthetic, have you heard of a spinal before?”

2. Make sure patients understand the positioning required for a spinal. This can make or break the procedure. It helps to visually demonstrate it to the patient when describing the procedure. Especially for patients with a language barrier – use the translator or family members to help you explain and show them how to sit.
   
   

3.  Similarly, for patients with a language barrier – ensure they can communicate to you a signal when they experience pain or more importantly a paresthesia, and which side. Sometimes I agree upon a hand signal with the patient beforehand.