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WHAT IS INTRATHECAL PAIN THERAPY?

 

Intrathecal pain therapy involves the delivery of small, controlled amounts of pain medication directly into the intrathecal space, an area filled with fluid that surrounds the spinal cord. This therapy was developed to reduce pain and to avoid the side effects that often accompany other treatments. Intrathecal pain therapy delivers pain medication directly to the receptors in the spinal cord and, therefore, requires significantly lower doses of medication to gain relief.

 

The Screening Process

 

Your doctor will explain why this pain treatment via an implanted pump is being recommended for you and will also arrange for a trial of intrathecal pain therapy. Participation in the trial allows you to evaluate how well intrathecal pain therapy will work for you to reduce your pain. Most patients who experience a successful trial can expect good to excellent pain relief when a pump is implanted.

During this trial, one of two standard procedures will be used to determine whether you gain significant (at least 50% improvement) pain relief.

 

Single Injection. This procedure consists of a single injection of a small amount of pain medication into your spinal canal.

 

Continuous Infusion. This procedure uses a continuous infusion of pain medication that is delivered via a temporary catheter placed near your spinal cord and attached to a small external pump. This trial takes place over several days and more closely resembles the therapy delivered by the implanted SynchroMed Infusion System.

The objective of the screening trial is to determine your response to intrathecal pain therapy. Successful therapy generally means at least a 50% reduction in pain, as well as improvements in your ability to function. Your doctor will closely monitor your response to the pain medication given in this trial and will work with you to determine if you are a candidate for long-term therapy with the SynchroMed Infusion System. Intrathecal pain therapy via the SynchroMed pump will not eliminated the primary source of your pain or "cure" the disease causing your pain.

 

WHAT IS THE SYNCHROMED INFUSION SYSTEM?

 

The SynchroMed Infusion System used to deliver the pain medication has two parts that are placed ("implanted") inside the body during a surgical procedure: a SynchroMed pump, which may or may not have an access port, and a catheter.

The pump is a round metal device that stores and releases prescribed amounts of medication directly into your body. It is about 1 inch thick, 3 inches in diameter, and weighs about 6 ounces.

The reservoir is the "cavity" inside the pump that holds the medication.

The fill port is a raised center portion of the pump through which the reservoir is refilled. A self-sealing rubber septum is located in the middle of this fill port. Your doctor or nurse inserts a needle through your skin and through the septum to fill the reservoir.

The catheter is a flexible tube used to deliver your medication from the pump directly to the intrathecal space.

The access port is an addition to some pumps that allows your doctor to inject other medications or sterile solutions directly into the implanted catheter bypassing the pump.

 

HOW THE SYSTEM WORKS

 

The SynchroMed pump automatically delivers a controlled amount of medication through a catheter to the intrathecal space around your spinal cord where it is most effective. The exact dosage, rate and timing prescribed by your doctor are entered into the pump using the programmer, an external computer-like device that controls the pump’s memory.

Information about your prescription is stored in the pump’s memory. Your doctor can easily review this information by using the programmer. The programmer communicates with the implanted pump by radio signals that allow your doctor to determine precisely how the pump is operating at any given time. Use of the programmer for changing your medication dosage can be done in the doctor’s office.

 

WHERE AND HOW WILL THE PUMP BE IMPLANTED?

 

The pump will be implanted during a surgical procedure that requires a brief hospital stay. Before the surgery, you and your doctor will decide together where to best position the pump for your personal comfort.

During the surgical procedure, your surgeon will form a pocket under your skin, usually in the lower abdominal area, that is large enough to hold the pump. A second small incision will be made over the spine in your lower back to insert one end of the catheter into your spinal canal. The other end is then tunneled around your side (under the skin) and attached to the pump. Once the catheter and pump are in place, the surgery is complete.

After surgery, there will be some discomfort and tenderness near the implant site. Your doctor may prescribe additional medication for incision pain relief and antibiotics to prevent infection. The chance of developing an infection, however, is slight, because the pump and catheter are both sterile and internal.

If you should notice any swelling, pain, or redness near your incision, be sure to call your doctor or nurse.

After the implant, your doctor will recommend that you restrict your activity for 6 to 8 weeks to reduce catheter movement. Once your incision has healed the pump site requires no special care.

Your health care staff is available to answer any questions or concerns you may have before and after the surgery. Your doctor and nurse understand your medical condition and they want to be helpful.

 

ENJOYING A MORE NORMAL LIFESYLE

 

As you begin to feel better, you will be able to resume your daily activities and enjoy a more normal lifestyle. Your awareness of the pump will lessen. Since there are no external parts, you may often forget it is there.

You may find that wearing loose clothing over the implanted pump is most comfortable. However, depending on your size and shape and where the pump is placed, it may not show at all under regular clothes.

Your doctor will prescribe and adjust the amount of medication to your level of pain and will inform you of any potential side effects of the medication you are receiving, such as drowsiness, nausea, dizziness, or breathing difficulties.

It may take several weeks until you begin to experience maximum benefits from the intrathecal medication. During this transition period, your doctor may reduce your opal pain medication as the intrathecal drug dosage is increased.

As you experience the benefits of the therapy, you should discuss your activity level with your doctor. You will find you will be able to resume activities and enjoy a more normal lifestyle. Follow your doctor’s suggestions about work, sexual activity, travel, recreation, hobbies, and exercise.

 

REFILLING AND CHECKING THE PUMP

 

The key to effective pain management is active involvement and cooperation with your health care team. One of your most important responsibilities is to ensure the maintenance of your pump by making regular return visits to your clinic for follow-up care.

Depending on the type and amount of intrathecal medication, follow-up visits to your doctor’s office or clinic may vary from weeks to months. These short visits are necessary for refills and prescription adjustments.

Your doctor or nurse will check the pump to make sure it is working properly by holding the programming wand near the skin over the pump. This wand allows the programmer to communicate with the pump’s memory via radio signals.

During a typical session, the pump will be emptied and refilled by an injection through the skin. This is a relatively easy and painless procedure. If necessary, your dosage will be adjusted by using the programmer.

It is very important to keep each refill appointment scheduled by your clinic. Timely refills are necessary to maintain the level of medication you need for continuous and effective pain control.

 

REPLACING THE PUMP

 

The battery in the pump should last 3 to 5 years depending on how much medication the pump delivers. The pump will need to be replaced at the end of battery life.

Each pump has a built-in alarm signal to let you know if there is a problem. Soft, high-pitched beeping sounds repeated several times per minute could indicate any of the following:

The pump needs refilling

The battery should be checked

The pump is not delivering medication

If you hear these signals at any time, call your doctor immediately to identify and correct the situation. You will have enough time to contact your clinic before the pump shuts down or the therapy stops working. During the clinic visit, your doctor will check the pump and manage any problems.

 

WILL ELECTRICAL EQUIPMENT OR MEDICAL TESTS INTERFERE WITH THE PUMP?

 

Under normal conditions, household appliances will not affect the pump, because built-in features protect it from this kind of interference.

You should consult with your doctor before engaging in activities that involve extreme or rapid pressure or temperature changes, (e.g., scuba diving, saunas, hot tubs, hyperbaric chamber treatment, long duration flights, nonpressurized aircraft, etc.). Extreme pressure or temperature changes may cause the pump to temporarily under- or overdispense medication.

You should also consult with your doctor before scheduling any additional therapies or diagnostic tests, i.e., MRI, lithotripsy, etc. Your doctor will determine if any precautions need to be taken.

 

PATIENT RESPONSIBILITIES

 

Although the pump is automatic, self-care and personal responsibility are also an important part of your therapy.

Schedule regular appointments with your doctor to refill your pump.

Keep all scheduled appointments during your treatment.

Ask questions about anything you do not understand.

Work together with your health care team to find the right medication and dosage to relieve your pain.

Carry your SynchroMed Pump Identification Card with you at all times (see Your Ientification Card).

Avoid physical activities that might involve the risk of trauma or a blow to the pump site.

Watch for any unusual reaction to the specific medication you are receiving. Call your doctor if you have any unfamiliar or adverse side effects.

Avoid alcohol and mood-alternating drugs- they can cause serious side effects.

Inform your family doctor and dentist that you have an implanted pump so they will be aware of this during any medical treatment.

Tell family members and friends that you have an implanted pump so they can assist you in any emergency.

Notify your doctor in advance to arrange for refills of the pump if you plan to travel extensively.

Follow your doctor’s directions- and take good care of yourself.

Call your doctor immediately if you experience any swelling, redness or pain near your incision, if you have any unfamiliar side effects or unusual symptoms, or if you hear beeping sounds from the pump.

 

BENEFITS OF INTRATHECAL PAIN THERAPY VIA THE SYNCHROMED INFUSION SYSTEM

 

The benefits of using intrathecal pain therapy via the SynchroMed Infusion System include:

Continuous intrathecal delivery reduces the need to take oral medication numerous times each day and it provides more complete pain relief.

The pump is programmed to automatically deliver pain medication into your body at the times and in the amounts selected by your doctor. The goal is to match your needs and maximize pain relief while minimizing drug side effects.

The dose, rate, and timing of your medication can easily be adjusted as your condition and the associated pain change over time.

Infusion therapy lessens the need for other medications to minimize pain, except for necessary periodical refills of the pump.

The drug is delivered directly to the intrathecal space around your spinal cord where it is known to exert its effect.

Your doctor has easy access to information about your medication and dosage through the pump’s memory.

The SynchroMed pump and catheter are an internal system that few people will notice.

You can enjoy a more normal and active lifestyle.

 

POTENTIAL RISKS

 

The potential risks of this therapy include any complication that can also occur with other types of surgery and anesthesia. There are some risks that are unique to the implantation of the SynchroMed Infusion System. They include infection, accumulation, of fluid in the pump pocket site, CSF leakage, bleeding, and spinal headaches. The catheter could leak, become kinked, disconnected, or dislodged, thereby requiring additional corrective surgery. A device component could fail, making it necessary to replace it. You could experience side effect or overdose symptoms of the drug being infused through the pump. It is important that you discuss with your doctor the potential risks, complications, and benefits regarding this therapy prior to giving your informed consent for treatment. Your doctor will be able to answer any questions you may have.

 

 

 

 

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