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.
Times vary depending on individual surgical techniques. On average, the procedure takes 1 to 4 hours from start to finish.
Typically, the surgery is performed under general anaesthesia. However, you may want to talk with your doctor about other options.
Depending on the doctor’s preference and hospital policy, a brief hospital stay may be recommended.
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.
The incision needs to be made where the pump will be implanted to help properly anchor the pump.
That depends on your specific condition(s). Your doctor may recommend a catheter location to the doctor performing your surgical procedure.
You'll begin receiving treatment as soon as medication flows from the implanted pump through the catheter into the fluid surrounding the spinal cord. Let your doctor know how you feel (too loose? not loose enough?) so dose adjustments can be made. Generally, you'll notice the effects of a dose adjustment in 6 to 8 hours, and the maximum effect in one or two days. It can take weeks, even months, to identify the dose and program that works best for you. This process (known as dose titration) takes time because ITB Therapy isn't "one size fits all."
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 that the drug delivery system is working properly.
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.
Potential surgical complications may include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, or bruising.
Your doctor can program the Medtronic pump to deliver a precise amount of medication to customize treatment to your needs. For example, the pump can be set to deliver less medication in the daytime, when you may rely on your stiffness to walk, transfer, or put on clothing, then deliver more medication at night to reduce spasticity to help you sleep more comfortably. Tell your doctor about the way you feel so changes can be made to optimize your therapy.
Your doctor will determine if you still need to take other medications.
It's very important to keep your pump filled with medication by attending your regularly scheduled refill appointments. It’s also important to watch for the warning signs of baclofen underdose (too little baclofen), including:
If not treated, underdose can quickly lead to serious baclofen withdrawal symptoms including high fever, changed mental status, or muscle stiffness, and in rare cases withdrawal may result in loss of function of many vital organs and death. Avoid withdrawal by watching for the warning signs of and symptoms of underdose and taking action. Both you and your caregivers must be familiar with these signs and symptoms what to do if you see them. Follow your doctor’s instructions on emergency care.
The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.
Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs 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 know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.
People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.
The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), 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. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. 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. You or your caregiver should always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.
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.