Pre-operation preparation
Different consults are systematically scheduled before the operation:
- A pre-surgery consult: for a clinical exam, to decide the date of the operation, and the location of the pump;
- An anesthesia consult;
- A pre-operation therapeutic education (TPE) session
The going of the intervention
The hospitalization lasts a week. You enter the Oncology Wing, the day before the intervention.
The intervention takes place under general anesthesia, with a radioscopic detection device. It last around 1 hour 30.
The surgeon punctures the lumbar area and places the catheter in the sub-arachnoid space. The flow of the cerebrospinal fluid will confirm that the catheter is well-positioned. The latter is then pushed forward towards the skull until the desired position – either thoracic or cervical is achieved, depending on where the pain is located. An incision is made in the abdominal area in order to prepare the capsule that will contain the pump, as well as the passage for the catheter’s network system. In the lumbar area, the two catheters are connected thanks to a subcutaneous device. In the abdominal area, the catheter is hooked up to the pump that will be pulled up into the subcutaneous capsule made under the incision.
Activating the pump
The pump is filled with a mix of 3 pain-killing products (Morphine, Ropivaïne, and Prialt) which is prepared in the pharmacy in pre-filled syringe, which is then transferred to the operating room. The concentration and the volume are carefully determined according to the estimated needs. The products’ concentration can be modified during a future fill-up, if necessary. The pump is activated at the end of the intervention, and, in the following half-hour, the mix reaches a dose in the cerebrospinal fluid which is “supposedly effective”. You should – from then on – feel some relief.
Post-operation monitoring
The post-operation monitoring happens for the first 24 to 72 hours in an Ongoing Monitoring Unit, then 72 hours minimum in the Oncology Wing until the painkiller’s doses are stabilized, before being released 7 days later in either your original Hospital or your home.
The monitoring in the Post-Intervention Monitoring Room (PIMR)
You will stay in Post-Intervention Monitoring Room for a night or two during the first titrations. Different parameters are kept in check:
- Blood pressure, saturation, pulse ;
- Temperature ;
- Pain assessment (Numerical Rating Scale or Visual Analog Scale);
- Complete neurological check-up: Glascow, pupils, motor function assessment, and sensitivity in all 4 limbs;
- Check-up of the puncture site, and locating the capsule to be implanted;
- Bladder Scan.
You have to stay bed-ridden for 24 to 48 hours. The areas where the catheter and the pump were put will be sensitive for a while.
A radiography of the entirety of the implanted material will be made on D+2.
Monitoring the intrathecal treatment
As soon as you are back in PIMR, the doctor will use the program several times a day to check-up on the intrathecal treatment’s efficiency and modify its parameters so that you feel it is as optimized as you feel it can be and/or neutralize its possible side effects. The doses are progressively increased, until it reaches the therapeutic dose necessary to relieve your pain.
Your state-certified nurse, on the other hand, plays her own essential role:
- She is responsible for your therapeutic education regarding the remote;
- She evaluates your pain, your neurological state;
- She is authorized – under medical control – to inspect the intrathecal pump (the number of boluses used, the volume of the reservoir) for the monitoring, and transmits of information from the medical personnel to treating doctor.
Getting back to your room
You can move as soon as you get back to your room, either alone or accompanied, depending on your clinical state. It is, however, recommended to limit physical activities for a few weeks – so that scars have the time to scar over. The bandages are easy to take care of, solely on the back and abdomen, since the intrathecal device is entirely implanted.
Leaving the Hospital
Your treating oncologist will readjust your usual treatment, while accounting for the current intrathecal treatment.
The SCN – State-certified Nurse – will establish your therapeutic education program. She will evaluate, on an at least daily manner, your pain and your neurological state, as well as any potentially occurring secondary effects. She will talk with you over the course of your stay at the hospital, then do it by phone once you leave – in order to figure out your biological, psychological, familio-social needs, and organize the resources necessary to a personal, and quality care.
The first post-operation consult – which is mandatory – whose purpose is to look over the evolution of the scarring, as well as an appointment to refill the medication, to limit unnecessary travel.
Filling the pump
The pump’s reservoir empties itself as the treatment and the boluses are administered. An alarm system will point out to you whenever it needs to be checked up on and/or filled up by the doctor. The frequency of those re-filling visits depends on the administered doses. You, thanks to the remote, and the healthcare team, informed by the program, know the reservoir’s alarm date. You will be informed of the refilling date by the Radiography Block of your referring Hospital. This act does not need any preparation, nor to fast. An Elma patch can be applied if you are sensitive or pained at the injection/withdrawing site. The refilling is done in an environment which is carefully and rigorously aseptic.
The pump will be completely emptied during that session, and then filled back up with the new mix, thanks to a Huber needle which is put into the pump, through the skin into the central septum.
When cancerous pain is concerned, refills are generally staggered out over 7 to 15 days but, in every case, the period between two refills must never exceed three weeks, because of the clinical stability of the products. It is imperative to scrupulously respect the follow-up appointments in order to make sure that the pump is filled up, that it is functioning correctly, and in order to adjust the administered doses to fight against the pain. The pump must always contain at least a minimal level of painkillers in order to avoid it malfunctioning, if not working entirely.
Monitoring the patient
A weekly check-up is carried out by the STN, by phone. That check-up’s goal is to get information on:
- Your general condition (physical or psychological);
- The evolution of your illness;
- The efficiency of the therapy on pain – the dose of the continuous treatment, the number of boluses, the efficiency of each of them;
- The apparition or the persistence of eventual secondary effects;
- Any new medical information (the result of blood or radiography exams), the debriefings of any consults (oncological ones), modifications of the usual treatment (non-intrathecal ones);
- Any events happening in your life which might affect you (bad falls, the illness or death of a relative or acquaintance).
Similarly, you are kept informed of the date/time/place of its refills.
Risks and complications
There are two main types of risks when installing an intrathecal pump: risks which have to do with delivered products, and risks which have to do with installing the material – pump and catheter.
Risks which have to do with the device
A local or systemic medical toxicity, and consequent secondary effects are possible. In order to severely limit that risk, the treatment’s preparations are made thanks to a program which allows for there to be safety in the mix’s prescription and preparation.
There is a possibility of there being an inflammatory mass which forms itself at one end of the implanted catheter, especially in the patients who were kept under intrathecal morphine or another opioid.
- The secondary effects will be different depending on the cause:
- Elevated levels of local anesthesia (LA): arterial hypotension, sensitive-motor deficits,
- A morphine over-dose: respiratory depression for up to 24 hours after the injection of the morphine in the cerebrospinal fluid, drowsiness, urinary retention, nausea and vomiting, pruritus, constipation,
- Under-dosing: pain and agitation,
- A zicotonide overdose: some rare cognitive disorders, hallucinations or spatio-temporal disorientation, since the initial doses are very weak.
Risks that have to do with the catheter and the pump
There are just as many risks in the implantation of the infusion system for an intrathecal dispensation than there are in any other brain surgeries. There are other undesirable side effects that might happen, other than those risks.
Immediately after the operation:
- Infections (which are a risk in 5% of all cases);
- Medullar hematomas;
- Wall hematoma.
After the operation, but not immediately so:
- Seroma, hematoma, erosion of infection of the capsule;
- Infection;
- The pump flipping on itself;
- Brain problems that have to do with the lumbar punction, issues with leaking CSF – cerebrospinal fluid – and its accumulation subcutaneously, some rare problems that have to do with the nervous central system (NCS), a radiculitis, an arachnoiditis, a hemorrhage, lesions in the spinal cord or a meningitis;
- An inflammatory mass which can cause neurological lesions, especially paralysis;
- An allergic reaction, which is rare, or an immune response to the implanted materials.
Questions from the patients
Is the intrathecal pump really capable of relieving people of cancer-caused pain ?
All the studies* report positive results with a decrease visible on the pain scores.
- 4 out of 13 studies show a betterment in the quality of life,
- 4 out of 13 studies show an improvement functionality,
- 8 out of 13 studies show a decrease in systemic treatments,
- 2 out of 13 studies show a decrease in the number of consults.
The studies also show that sleep and mood will get better. The clinical trials listed in the last few years lead to similar results about its efficiency, its capacity to reduce symptoms, and the betterment of the quality of life which is intrinsically linked to the decrease of the painkiller’s secondary effects.
*SFAR/SFETD – chiffres 2015 de la ligue contre le cancer. Techniques analgésiques locorégionales et douleurs chroniques
When must the pump be changed?
The pump works thanks to a battery which generally lasts around 3 to 4 years, depending on how often the refills must be done: the more there are repeats, the shorter the pump will last. Changing the pump happens under general anesthesia. The surgeon goes back on the old scar used to contain the pump’s capsule , without ever touching the catheter, then disconnects the catheter’s distal extremity, he inserts the new pump, reconnects the catheter and then sutures the scar.
Must-I take some precautions when wearing an intrathecal pump?
Indeed, there are some official contra-indications:
Using arc welding material;
- Going under airport security gates;
- Using magnets;
- Practicing combat sports;
- Extreme leisure activities – thrill rides, hand-gliding, paragliding, jumping in parachute, bungee jumping);
- Exposing the material to extreme heat (hammam, jacuzzi, sauna, boiling baths, UV).