Questions and Answers – Getting ITB Therapy
Am I a candidate for Medtronic ITB TherapySM?
Medtronic ITB Therapy (Intrathecal Baclofen Therapy) for severe spasticity is not right for everyone. Only a doctor experienced with ITB Therapy (the baclofen pump) can determine whether or not you are a candidate.
On average, how long does the surgery take?
Times vary depending on individual surgical techniques. On average, the procedure takes 2 to 3 hours from start to finish.
What type of anesthesia is used?
Typically, the surgery is performed under general anesthesia. However, you may want to talk with your doctor about other options.
What is the average length of the hospital stay?
The procedure may be performed on an outpatient basis. However, depending on the doctor’s preference and hospital policy, a brief hospital stay may be recommended.
How big are the incisions from surgery?
The abdominal incision where the pump is placed is about 6 inches long. A second incision (about 2 to 3 inches long) is made on your back to place one end of the catheter into the intrathecal space.
Can a previous abdominal incision be used to place the pump?
The incision needs to be made where the pump will be implanted to help properly anchor the pump.
Between which vertebrae is the catheter placed?
That depends on your specific condition(s). Your doctor may recommend a catheter location to the doctor performing your surgical procedure.
How long will it take before I start receiving benefit from ITB Therapy?
You'll begin receiving treatment as soon as the pump is filled with medication and the medication travels through the catheter to the intrathecal space. You may feel effects from the medication soon after delivery, or it may take awhile for you to experience benefits. It may take weeks to months to reach your optimal dose.
What if I show no improvement after ITB Therapy begins?
Let your doctor know if you’re not receiving adequate control of your condition and/or symptoms. The doctor can typically reprogram the pump to adjust the amount of medication it delivers. In other cases, your doctor may need to further evaluate your system to ensure adequate drug delivery.
What are the most common side effects of Lioresal® Intrathecal (baclofen injection)?
The side effects of Lioresal Intrathecal include loose muscles, sleepiness, upset stomach and vomiting, headaches, and dizziness. Talk with your doctor about the possible side effects you may experience from your treatment, and see the Full Prescribing Information for Lioresal Intrathecal.
More: Full Prescribing Information
What are the potential surgical complications?
Potential surgical complications may include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, or bruising.
What if I need some spasticity for transfers, walking, or standing? Will ITB Therapy take this away?
Your doctor can program the Medtronic SynchroMed® pump to deliver the precise amount of medication that you need.
Can I stop taking other medications once I have ITB Therapy?
Your doctor will determine if you still need to take other medications.
What happens if the programmable pump runs out of medication?
It's important to keep your pump filled with medication by attending your regularly scheduled refill appointments. It's also important to understand the early symptoms of baclofen withdrawal such as:
- High fever
- Changed mental status
- Muscle rigidity
- Multiple organ-system failure and death (in rare cases)
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call
IMPORTANT SAFETY INFORMATION ON ITB THERAPY
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.
It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.
The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.
The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia, seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.
For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.
This therapy is not for everyone. Please contact your doctor. A prescription is required.
Lioresal® is a registered trademark of Medtronic, Inc.
USA Rx Only Rev 0911
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
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