What is an Intrathecal Pump Implant ("Spinal
Morphine Pump")?
An Intrathecal Pump is a computerized device, which delivers concentrated amounts
of medication(s) into spinal cord area via a small catheter (tubing).
Am I a candidate for Intrathecal Pump Implant
("Spinal Morphine Pump")?
Currently, the Intrathecal Pump is offered to patients with:
1. Chronic and severe pain, who have not adequately responded
to other treatment modalities. Some of the examples are failed back syndrome,
cancer pain, RSD. These patients will receive infusion of painkillers such as
Morphine or Dilaudid. Other medicines such as Clonidine or Local Anesthetics
may also be used in conjunction.
2. Spastic disorders such as Multiple
Sclerosis,
Spinal Cord Injury - associated with muscle spasms. These patients receive
infusion of an antispasmodic medication called Baclofen.
Indications
Chronic intrathecal or epidural infusion of preservative-free morphine sulfate
for chronic, intractable pain of malignant or nonmalignant origin. Chronic
intrathecal infusion of LioresalÆ Intrathecal (baclofen injection) for severe
spasticity.
Before
proceeding with the actual implant, a series of steps will have to be taken.
You will need to be evaluated by a Medical Psychologist with experience in
chronic pain management. Assuming that your psychological profile does not
contraindicate the implant therapy, you will then have to undergo an "intraspinal
medication trial". This trial is design to find out if you have
any problems with the medications that may be used in the infusion pump.
You will be
admitted to the Hospital on a Monday. On that day you will receive your first
spinal injection. The procedure will be repeated on Tuesday and Wednesday. On
Thursday morning you will be sent home and a week later, we will see you back
in the Pain Center to discuss the results. During those three days, you will
receive a total of three (3) spinal injections, one each day. Two of them will
contain an active medication (this can be a narcotic, an antispasmodic, a local
anesthetic, or some other type of active drug), and one of them will have an inactive
medication (water, saline, etc.). We will not tell you which one is which, but
obviously, if you cannot tell the difference between morphine and water, we do
not need to proceed with the implant.
Provide the
patient with the best possible results, by identifying any possible problems,
early. The trial is similar to a "Test Drive" prior to purchasing a
car. It allows you to see how it feels, before you commit to it.
We look for
two things. The first is to see if the medicines will be effective in providing
you with the desired relief of the pain. The second is to find out if you will
be able to tolerate the medication well without experiencing any side effects.
…
Urinary
retention
…
Nausea
& Vomiting
…
Itching
…
Weakness
…
Facial
flushing
…
Constipation
…
Joint
Pain
…
Muscle
twitching
…
Oversedation
…
Sleepiness,
somnolence
…
Respiratory
depression
…
Lack of
effectiveness
…
Disorientation
Note: Changing medications or doses may
solve some of these, others may indicate poor candidacy for implant.
Just like
any other medical procedure, it has its risks and possible complication. Some
of these may include bleeding, infection, nerve damage and death. These are
rare, but need to be mentioned because they are always possible. The more
commonly encountered problems are the above described side effects.
What is the purpose of the pump?
This device delivers concentrated amounts of medication into spinal cord area
allowing the patient to decrease or eliminate the need for oral medications. It
delivers medication around the clock, thus eliminating or minimizing
breakthrough pain and/or other symptoms.
How long does the procedure take?
It is done in two stages. In the first stage, a series of injections are made
to assess effectiveness and screen for unwanted side effects. If this trial is
successful in relieving symptoms, then the permanent device is placed under the
skin. The patients have to meet certain other screening criteria before
implanting the pump.
Will the procedure hurt?
The procedure involves inserting a needle through skin and deeper tissues (like
a "tetanus shot"). So, there is some discomfort involved. However, we
numb the skin and deeper tissues with a local anesthetic using a very thin
needle prior to inserting the needle. Most of the patients also receive
intravenous sedation and analgesia, which makes the procedure easy to tolerate.
Will I be "put out" for this procedure?
No, the placement of the pump is done under regional anesthesia and intravenous
sedation. The amount of sedation given generally depends upon the patient
tolerance. The procedure is divided in two stages. The first stage (tubing
placement) is done with the local anesthesia and sedation, for safety purposes.
At the beginning of this stage, the patients will experience a stick and the
sting from the local anesthetic. This is the only uncomfortable part of the
procedure. Once the tubing is in place, local anesthetic is injected through it
to confirm adequate placement and to obtain anesthesia on the entire surgical
field. From this point on, the rest of the procedure is completely painless.
How is the procedure performed?
It is done with the patient lying on the side. The patients are monitored with
EKG, blood pressure cuff and blood oxygen-monitoring device. The skin is cleaned
with antiseptic solution and then the procedure is carried out. X-ray
(fluoroscopy) is used to guide the needle for inserting the tubing.
Where is the tubing inserted? Where is the pump
placed?
Tubing is inserted in the midline at the lower back. The pump is then placed on
the side of the abdomen.
What should I expect after the procedure?
If the procedure is successful, you may feel that your pain may be controlled
or quite less. The pump is adjusted electronically to deliver adequate amount
of medication. As for any other surgical procedure, it will take 8-10 weeks for
the wound to heal to the point where the skin strength is back to normal.
What should I do after the procedure?
This procedure is normally a day-procedure. After a one to two hour recovery
period, you will be allowed to go home. You must have a responsible, strong
adult drive you home. This person should be able to assist you in moving if you
are still weak from the anesthetics. You should plan to rest for the remainder
of the week.
How long will the pumps last?
The medication contained within the pump will last about 1 to 3 months
depending upon the concentration and amount infused. It is then refilled via a
tiny needle inserted into the pump chamber. This is done in the office and it
only takes a few minutes. The batteries in the pump may last 3 to 5 years
depending upon the usage. Newer devices have been tested and estimated to last
8 years. The batteries can not be replaced or recharged. The entire pump is
replaced at that time.
Will the Intrathecal Pump Implant ("Spinal
Morphine Pump") help me?
It is very difficult to predict if the procedure will indeed help you or not.
For that reason a trial is carried out to determine if a permanent device
(pump) will be effective to relieve your pain or not.
What are
the risks and side effects?
Generally speaking, this procedure is safe. However, with any procedure there are
risks, side effects, and possibility of complications.
Adverse Events
Include, but not limited to, cessation/change in therapy due to battery
depletion or component failure; pocket seroma, hematoma, erosion or infection;
complete or partial catheter occlusion, kinking, breakage, leakage or
disconnection; catheter dislodgment or migration; bleeding; arachnoiditis;
meningitis; spinal headache; drug toxicity and related side effects; and
procedural complications.
As with any
treatment, side effects can occur. For example, because the pump and catheter
are surgically placed, surgical complications, such as infections, are
possible. Other potential complications include fluid accumulation around the
pump, spinal fluid leaks resulting in headache or other problems, and damage to
the spinal cord. The catheter could become dislodged or blocked or, in rare
cases, the pump could stop working. This could cause a reduction in or loss of
pain relief and may require surgery to correct. The most common drug side
effects reported are itching, urinary retention, and constipation.
Warnings
Use only with preservative-free drugs. Although only a few medications have
been FDA (Food and Drug Administration) approved, certain other drugs may be
safely used by experienced clinicians. Clinically significant or fatal drug
overdose may result from improper use such as over-pressurization of the pump
reservoir; improper injection of drug through the side catheter access port or
into the pump pocket; or failure to account for significant amounts of drug
which may reside in the catheter, side catheter access port, pump tubing, and
the reservoir.
Precautions
Only qualified personnel should implant, program, fill and refill the
Intraspinal (also referred to as "Intrathecal") pump or access the
side catheter access port. Maintain strict aseptic technique during all
procedures. Consider use of peri- and postoperative antibiotics for pump
implantation and any subsequent surgical procedures. Care must be taken in the
pediatric population to select an appropriate anatomical pump site. Initial
fill and refill volumes must not exceed levels specified in the technical
manuals. Always use a template when accessing the implanted pump's center
reservoir fill port or side catheter access port. Do not expose the pump to
temperatures above 43ƒ C (110ƒ F) or below 5ƒ C (40ƒ F). Do not implant a pump that has
been dropped onto a hard surface or shows signs of damage. Do not steam
autoclave or flash autoclave the pump. Magnetic Resonance Imaging (MRI) will
temporarily stop the pump motor and suspend drug infusion for the duration of
MRI exposure. The pump should resume normal operation upon termination of MRI
exposure. During an MRI scan, the patient may experience heating or peripheral
nerve stimulation at or near the pump implant site. In the unlikely event that
this happens, the MRI scan parameters should be adjusted to reduce Specific
Absorption Rate (SAR) for heating or dB/dt for nerve stimulation or both. Upon
completion of an MRI scan, the pump parameters should be confirmed using a
SynchroMedÆ Programmer. SynchroMed pump performance has not been established in
>2.0 T (Tesla) MR scanners, and it is not recommended that patients have MRI
scans using these scanners.
CAUTION:
Federal law (U.S.A.)
restricts this device to sale by or on the order of a physician.
Who should not have this procedure?
If you are on a blood thinning medication (e.g. CoumadinÆ), or if
you have an ongoing, active infection, you should not have the procedure. The
patients also have to meet certain other screening criteria before implanting
the pump.
Contraindications
When infection is present; when the pump cannot be implanted less than 2.5 cm
(one inch) from the surface of the skin; when body size is not sufficient to
accept pump bulk and weight; when contraindications exist related to the drug.
This is
dependent not on the pump, but on other factors. Statistics will show that
patients who have been out of work for longer than one (1) year, have less than
15% probability of returning to the work force.
Where can I get additional information?
More detailed information is available from the manufacturer of this device. At
the time of consultation you will receive a Synchromedô Infusion System Patient
Education Booklet. Additional information is also available at the Medtronicsô
Web Site @ http://www.medtronics.com/neuro/apt/faq.html.
You will
play an important part in the success of your therapy. Your restrictions and
responsibilities for are listed below.
Pre-surgical information
1. Carefully read the above information.
2. Be sure you understand the goal of
the therapy, benefits and risks. Discuss questions with your doctor, before
the surgery.
3. Discuss placement of your pump with
your doctor; avoid placing near belt line, rib cage, and pelvic bone or in a
place it would be affected by restrictive clothing. It is generally placed to
the side of the lower abdomen. (Avoid any Radiation Therapy sites)
4. The evening prior to your surgery,
shower or bathe with an antibacterial soap such as "Dial",
"Safeguard" or any bar stating it contains an "antibacterial".
Post-surgical Information
1. Always carry your Emergency
Information Card. Always carry your identification card or wear a medic alert
bracelet.
2. Until your site is well healed wear
loose clothing over the site to avoid irritation. Plan to wear an abdominal
binder for 6-8 weeks after your surgery, to stabilize the pump in the surgical
area.
3. Keep all scheduled refill and follow
up visits.
4. Attend to your appointments in a
timely manner.
5. Notify other doctors you are seeing
that you have an implantable device.
6. Avoid any activity that involves
extreme pressure changes such as skydiving or scuba diving. You may fly, but
should carry your Identification card with you as your pump may set off metal
detectors. Avoid MRI, diathermy, radiation therapy and hyperbaric chamber
therapy until you discuss these with your doctor.
7. Notify your doctor if you develop
redness, swelling, drainage or unusual pain at your pump site.
8. Remember that it may take up to three
months for us to find your "best" dose.
9. Remember to take your antibiotics
after the surgery.
10. It will take approximately 8 (eight)
to 10 (ten) weeks for everything to heal. Do not do any heavy lifting or
strenuous activities until then.
11. Make sure to wear your abdominal
binder all of the time, until instructed not to. (4-6 weeks)