INFORMED CONSENT FOR RISKS AND MEDICAL NECESSITY OF INVASIVE PROCEDURES I understand that there are risks associated with invasive pain management. These risks include but are not limited to the following: Risks of Injection: 1. nerve injury. 2. spinal cord injury 3. brain injury (stroke) 4. paralysis 5. muscle injury 6. joint injury 7. infection 8. bleeding 9. pneumothorax (collapsed lung) 10. increased pain 11. death Risks of steroid: 1. insomnia 2. increased appetite. 3. weight gain. 4. fluid retention 5. changes in body shape. 6. muscle atrophy 7. mood changes 8. adrenal suppression (shutting down of body's own steroid production) 9. skin changes. 10. osteoporosis 11. vertebral body compression fracture. 12. avascular necrosis of the hip (chronic hip fracture) 13. bleeding stomach ulcers 14. cataracts I understand that my injection could cause short-term weakness, and/or numbness in my arms or legs, as well as balancing difficulties and visual disturbances. If any of these symptoms occur after my injection, I agree not to drive. I agree that I will wait in the clinic until my symptoms subside, I will find alternative transportation home, or I will be transported to another medical facility for ongoing management. MEDICAL NECESSITY FOR INVASIVE PAIN MANAGEMENT I have consented to undergo an invasive procedure for the purpose of pain management. I understand that there are potential risks and potential benefits of this procedure. I certify that this procedure is medically necessary for the following reasons: □ My pain is severe for significant periods of time. □ My pain is interfering with my ability to function and to perform activities of daily living. □ My pain has not completely responded to more conservative non-invasive management. The risks and issues with invasive pain procedures have been explained to me to my satisfaction and my questions have been answered. PATIENT SIGNATURE:__________________________________________ Consent for Interventional Pain Management Procedure Procedure: ____________________________________________________________________________ You are about to undergo an invasive procedure for the purpose of diagnosis and/or treatment of persistent pain. The procedure we are recommending requires placement of needles into the body and injections of medicines, anesthetics and/or chemicals into the body. In addition, if you are undergoing a nerve destruction procedure such as radio frequency nerve ablation or chemical neuroablation, nerve-destroying heat current and/or nerve-destroying chemicals may be delivered to your body. We believe that the procedure you are about to receive will help you to become more pain free. However, there is no guarantee that the procedure will relieve your pain and there is a possibility that your pain may be the same or worse afterward. Persistent pain is often very difficult to diagnose and treat, and we can only use our best judgment and medical expertise to recommend and perform interventions that we hope will help you. As with most interventions in medicine, there is considerable risk to invasive pain therapies. Risks include but are not limited to the following: bleeding, infection, damage to nerves or spinal cord, damage to blood vessels or other body tissues, toxic or allergic reactions to medications or chemicals injected, accidental injection into the blood vessels or spinal fluid, paralysis and/or death. Special Notes: _________________________________________________________________________ Please ask any questions you may have prior to signing this consent. Patient Signature: _______________________________________________________________________ Physician Signature: _____________________________________________________________________ Witness: ______________________________________________________________________________ Date: _______________________ ******************************************************** I, _____________________________________, viewed the video “Risks Associated with Pain Patient Name Clinic Procedure” on ___________________. Date _________________________________________ Patient Signature ******************************************************** According to records, patient viewed the video “Risks Associated with Pain Clinic Procedure” on _______________________ _________________________________________ Date Staff Signature CONSENT FOR MEDICATION USE At MAPS we may be using specially prepared medications obtained from a custom compounding pharmacy to inject into your spine or other parts of your body or placed in your pump for continuous delivery. These medications are prepared to our specifications without preservatives using standard compounding techniques. The medications we obtain from the compounding pharmacy are all commonly used for spinal injections and pump fills and are sometimes purchased from a manufacturing pharmacy. Due to a recent national shortage of these medications, we have had difficulty obtaining our usual spinal medications from the manufacturing pharmacies. We have therefore decided to obtain the medications from a compounding pharmacy. The compounding pharmacy is different from the manufacturing pharmacy in that the Food and Drug Administration (FDA) does not monitor and does not regulate the compounding pharmacies. The FDA does monitor and regulate the manufacturing pharmacies. Nonetheless, we have every confidence in the safety and efficacy of the compounded medications. Please sign this consent confirming that you understand that some or all of the medications injected into your body may have been created by a compounding pharmacist without FDA regulation. If you have any questions regarding compounding medications, please ask the doctor or nurse to explain further. Thank you. ______________________________ Patient Signature _______________ Date ______________________________ Witness Signature _______________ Date