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PubMedDate not supplied

Intrathecal baclofen therapy: challenges in patients with multiple sclerosis.

Intrathecal baclofen (ITB) is a recognized therapy for severe spasticity of both spinal and cerebral origin, with documented positive clinical outcomes for many patients with multiple sclerosis (MS). This article reviews some specific considerations concerning the use of ITB in the MS population, based on the author's 10 years of clinical experience. The unpredictable and progressive nature of the disease affects the identification of appropriate goals, the patient's decision-making process, and the evaluation of the response to the treatment over time. Patients with MS may be more sensitive to intrathecal baclofen than patients with other diagnoses, and may need a lower dose for both the screening test and maintenance therapy. Subtle cognitive changes may affect the patient's ability to understand the education needed for successful management of ITB. Some practical strategies are offered for the nurse involved in the care of these patients in each stage of the therapy.

Activities of Daily Living↗
PubMed2006

Intrathecal baclofen overdose and withdrawal.

Intrathecal baclofen (ITB) therapy is being used increasingly to treat medically intractable spasticity in children with cerebral palsy and spinal cord injuries. Baclofen overdose and withdrawal are potentially life-threatening complications of pump and spinal catheter system malfunction. We report a case of a 12-year-old boy, on long-term ITB therapy, who presents to our emergency department with an overdose of ITB, which is followed by withdrawal symptoms. The patient initially presented obtunded and in respiratory arrest. His symptoms of respiratory arrest, obtundation, fixed pupils, and hypotension mimicked other diagnoses, such as head trauma. The history obtained from the family about the pump reservoir being refilled just before the onset of symptoms led to the diagnosis. During hospitalization, as the patient recovered from the overdose, he began to experience symptoms of baclofen withdrawal, including hypertension, hyperthermia, and hallucinations. The pump was found to be disconnected and was revised. The patient was discharged home without permanent sequelae. With increased use of ITB, emergency medicine physicians must be aware of the mechanics of these pumps and the management of baclofen toxicity and withdrawal.

Baclofen↗
PubMed1984

The role of spinal pathways in dopamine mediated alteration in the tail-flick reflex in rats.

The latency of the tail-flick, following intrathecal infusion of the dopamine (DA) agonist, R-apomorphine was measured in rats with intact spinal cord or with spinal cord lesions. Apomorphine failed to influence the tail-flick response in intact rats, whereas it elevated the latency of the tail-flick in rats with either total spinal cord transection, or bilateral lesions of the dorsolateral funiculi (DLF), but not in rats with lesions in either the dorsal columns or the medioventral parts of the lateral funiculi. The findings suggest that pathways in the dorsolateral funiculi modulate DA-mediated sensory processes and possible mechanisms are discussed.

Animals↗
PubMed2003

Urodynamic effects of intravesical nociceptin/orphanin FQ in neurogenic detrusor overactivity: a randomized, placebo-controlled, double-blind study.

OBJECTIVES: To evaluate the acute urodynamic effects of the neuropeptide nociceptin/orphanin FQ (N/OFQ) in a selected group of patients with neurogenic detrusor overactivity incontinence in a randomized, placebo-controlled, double-blind study. METHODS: The study involved 14 patients who presented with neurogenic detrusor overactivity due to spinal cord injury. They were randomized to receive intravesical infusion of 1 microM N/OFQ or the same dose of [desPhe(1)]N/OFQ (the placebo). The urodynamic parameters were the bladder capacity, volume threshold for the appearance of detrusor overactivity, and the maximal bladder pressure. The study was performed on a double-blind basis: neither the patients nor the doctors who performed the instillation could distinguish the solution containing N/OFQ from that containing [desPhe(1)]N/OFQ. Data are expressed as the mean +/- SD of seven determinations. Data were statistically analyzed using the Student t test for paired or unpaired data and P <0.05 was set as the criterion for a statistically significant difference. RESULTS: The two groups were well balanced with respect to mean age, male/female ratio, etiology of spinal cord disease, and years from the lesion. Also, the baseline mean values of bladder capacity, volume threshold for the appearance of detrusor overactivity, and maximal bladder pressure were similar. The intravesical infusion of the solution containing 1 microM N/OFQ produced the following changes: bladder capacity and volume threshold for the appearance of detrusor overactivity significantly increased from 139 +/- 48 mL to 240 +/- 61 mL, and from 84 +/- 32 mL to 201 +/- 68 mL, respectively. Maximal bladder pressure decreased from 81 +/- 25 cm H(2)O to 66 +/- 12 cm H(2)O; however, this difference was not statistically significant. The intravesical infusion of the solution containing 1 microM [desPhe(1)]N/OFQ did not produce any statistically significant modification of the urodynamic parameters. CONCLUSIONS: The results of this study confirm and extend previous results showing that N/OFQ, but not the placebo, elicits a robust acute inhibitory effect on the micturition reflex in patients with a neurogenic bladder. These findings apply nociceptin orphan peptide receptor agonists as potential novel drugs for the treatment of neurogenic urinary incontinence.

Administration, Intravesical↗
PubMed1994

Intrathecal baclofen for treatment of intractable spinal spasticity.

This study assessed the safety and efficacy of intrathecal baclofen in the treatment of intractable spasticity caused by spinal cord injury or multiple sclerosis. Twenty-three patients with severe chronic spasticity underwent bolus test dosing with 50, 75, or 100 micrograms of intrathecal baclofen administered by lumbar puncture. All patients were either refractory to oral baclofen at a dose of 120 mg/d or side effects were unacceptable at a lower dose. There was a significant decrease in tone and spasticity in all 23 patients. Nineteen patients underwent implantation of a programmable pump and intrathecal catheter designed to deliver baclofen directly to the spinal cord. Rigidity (tone) was decreased from a mean prebolus Ashworth score of 3.8 to a mean postbolus Ashworth score of 1.5 and spasms from a mean prebolus score of 3.5 to a mean postbolus score of 1.2 for a minimum of 4 hours. Patients have been observed for a mean of 16 months (range 2 to 34 months). Ashworth scores have remained reduced to an acceptable level (< or = 2 with periodic adjustment in dosage in all but three patients. There has been one pump malfunction and four catheter malfunctions; few serious medication and postoperative complications have occurred. There was one death caused by underlying disease, one patient voluntarily withdrew, and three patients developed tolerance to the extent that optimal control of spasticity tone could not be maintained. Although intrathecal baclofen is safe and effective in the majority of patients, three patients required > 1,000 micrograms/d with increasingly higher doses over time and exhibited a poor response.

Adult↗
PubMed2004

Long term effect (more than five years) of intrathecal baclofen on impairment, disability, and quality of life in patients with severe spasticity of spinal origin.

OBJECTIVES: To evaluate long term change in impairment, disability, and health related functional status in patients with severe spasticity who received intrathecal baclofen. METHODS: A long term (more than five years) observational longitudinal follow up study assessing 21 patients who received intrathecal baclofen given by programmable pump. Patients had chronic disabling spasticity which did not respond to oral antispasmolytic agents. Clinical efficacy was assessed by the Ashworth scale and spasm score; disability by the expanded disability status scale (EDSS), ambulation index (AI), and incapacity status scale (ISS); and health related quality of life by the sickness impact profile (SIP) and the Hopkins symptom checklist (HSCL). RESULTS: Compared with pretreatment values, there was a significant improvement in clinical efficacy (Ashworth scale and spasm score, p<0.05) but a small but significant worsening of disability (EDSS, AI, and ISS, p<0.05). Comparing pretreatment with 26 weeks after pump implantation, a worsening was observed in disability (EDSS and ISS, p<0.05) and perceived health status (SIP, psychosocial dimension, p<0.05). CONCLUSIONS: Long term administration of intrathecal baclofen delivered by an implanted programmable pump resulted in improved clinical efficacy but not in improvement in disability or perceived health status.

Activities of Daily Living↗
PubMedDate not supplied

Two cases of cauda equina syndrome following spinal-epidural anesthesia.

BACKGROUND AND OBJECTIVES: Cauda equina syndrome (CES) is a well-known complication of spinal and epidural anesthesia. Previous reports have implicated lidocaine, chloroprocaine, and procaine in its etiology, but not bupivacaine. METHODS: A 63-year-old man underwent transurethral resection of the prostrate for which he received bupivacaine with glucose intrathecally. Postoperative, he had difficulty in urination and defecation, and magnetic resonance imaging revealed spinal stenosis at the L1-L2 level. The second patient was a 70-year-old woman who underwent hip replacement surgery using a combined spinal-epidural technique. Postoperative, after 42 hours, when the epidural infusion of bupivacaine was stopped, the patient had difficulty in urination and defecation. No anatomical abnormality was found on magnetic resonance imaging. RESULTS: The two patients developed cauda equina syndrome following bupivacaine with glucose injected spinally, and bupivacaine without glucose injected in a combined spinal-epidural technique. CONCLUSIONS: This case report describes two cases of CES following the use of bupivacaine. The first patient had spinal stenosis which could explain this complication; however the explanation for CES in the second patient is uncertain and consequently speculative. We have discussed the possible contributing factors but believe that the etiology of CES in the second patient remains unknown.

Aged↗
PubMed1997

Prevention of spinal anesthesia-induced hypotension in the elderly: comparison between preanesthetic administration of crystalloids, colloids, and no prehydration.

The practice of routinely prehydrating patients by infusing a crystalloid or colloid solution (up to 1.0 L/70 kg) for prevention of spinal anesthesia-induced hypotension has been challenged recently, after several reports of failure to demonstrate its efficacy in young women. We compared the incidence and frequency of hypotension and vasopressor therapy after spinal anesthesia and no prehydration with crystalloid and colloid prehydration in elderly patients. Eighty-five ASA grade I or II patients (aged 60-89 yr) for elective total hip replacement were randomized to receive 500 mL crystalloid solution (Hartmanns, n = 29), 500 mL colloid (Haemaccel, n = 28), or no prehydration (n = 28) over 10 min prior to spinal anesthesia. Hypotension was defined as a 30% decrease from baseline systolic blood pressure (BP) or systolic < 90 mm Hg, and was treated with ephedrine 3-mg boluses. Although absolute systolic BP readings were significantly higher in the colloid group between 6 and 30 min (P < 0.05), the incidence of hypotension was not significantly different between the groups. The incidence of ephedrine use, incidence of nausea/vomiting, and median total dose of ephedrine were similar in all groups. We conclude that, in elderly patients undergoing elective procedures, withholding prehydration is not associated with any greater degree of hypotension or need for vasopressor therapy compared with crystalloid or colloid prehydration.

Aged↗
PubMed1997

Impact of peripherally inserted central catheters on phlebitic complications of peripheral intravenous therapy in spinal cord injury patients.

We investigated the impact of peripherally inserted central catheter (PICC) placement in spinal cord injury patients at high risk for infusion phlebitis. The rate and etiology of phlebitis was investigated in two phases. During Phase I, peripheral IV cannulae and conventional central venous catheters (CVC) were used. During Phase II, patients identified to be at risk for phlebitis received PICCs. The number of peripheral IVs, CVCs and PICCs was tabulated for both phases of the study. Technical, infectious and thrombotic complications were studied prospectively for PICCs and retrospectively for CVCs. We found the rate of phlebitis was 16.5 percent and 2.4 percent for Phases I and II, respectively (p = 0.0002). Three infections occurred in 38 PICCs and one infection was documented in 13 conventional CVCs. The number of peripheral IVs and conventional CVCs was reduced significantly from Phase I to Phase II. No procedural complications, catheter sepsis or clinically apparent venous thrombosis occurred. In conclusion, PICCs reduced the rate of phlebitis thresholds with a low complication rate and reduced the use of peripheral IVs and conventional CVCs.

Catheterization, Central Venous↗
PubMed2000

Comparison of hypotensive epidural anaesthesia and spinal anaesthesia on blood loss and coagulation during and after total hip arthroplasty.

BACKGROUND: Hypotensive epidural anaesthesia (HEA) is a technique for reducing peroperative blood loss by significantly lowering mean arterial pressure (MAP). METHODS: Thirty patients scheduled for primary total hip arthroplasty were given HEA (n=15) or spinal anaesthesia (SPA) (n= 15) with bupivacaine in random order. The dose of bupivacaine was titrated to provide epidural blockade up to T1-T4 and spinal blockade at least to T10. Intravenous adrenaline infusion was adjusted to achieve a MAP of about 50-60 mmHg in the HEA group. During SPA MAP was maintained above 70 mmHg with ephedrine, as needed. RESULTS: Intraoperative blood loss (median and 25th and 75th percentiles) was 400 ml (163-575) in the HEA group and 900 ml (663-1,100) in the SPA group (P<0.05). At 3 h postoperatively cumulative blood loss was still smaller in the HEA group (600 ml versus 1,100 ml, P<0.05). The cumulative number of transfused packed red cell concentrate (PRC) units was smaller in the HEA group than in the SPA group during surgery and postoperatively. Prothrombin time value was smaller in the SPA than in the HEA group (69% versus 79%, P<0.05) at 3 h postoperatively. D-dimer concentrations increased more in the SPA group at the end of the surgery and 3 h postoperatively (P<0.05). CONCLUSIONS: HEA resulted in reduced blood loss due to hypotension and reduced number of transfused PRC units during total hip arthroplasty. Based on lower prothrombin time value and higher D-dimer concentrations in the SPA group, the coagulation system might be better preserved during HEA than SPA.

Aged↗
PubMed2003

[Severe hypotension during anesthesia in a patient on long-term antidepressant therapy].

A 71-year-old woman on chronic therapy with mianserine and amantadine was scheduled to undergo abdominal hysterectomy under spinal anesthesia. Following spinal anesthesia she developed hypotension refractory to continuous intravenous fluid infusion as well as multiple boluses of ephedrine. Because the maximum level of analgesia was T 8, general anesthesia was added using laryngeal mask airway. Immediately after anesthetic induction, a marked hypotension occurred. Blood pressure again did not respond to ephedrine but went up excessively to a small dose of epinephrine without any changes in heart rate. Epinephrine infusion at a low dose rate was needed to sustain the blood pressure during surgery. Both depletion of presynaptic norepinephrine store and down-regulation of postsynaptic beta-receptor may have led to abnormal response to catecholamines in this case.

Aged↗
PubMed1974

The response to distension of the pulmonary vein-left atrial junctions in dogs with spinal section.

1. A reflex increase in heart rate in response to pulmonary vein distension was observed in decerebrate dogs. This increase could not be totally abolished by treatment with both propranolol and bretylium tosylate. Only bilateral cervical vagotomy abolished the reflex increase in heart rate.2. A significant increase in heart rate occurred in a total of seventeen spinal dogs during pulmonary vein distension.3. In seven spinal animals in which blood pressure was maintained by the continuous infusion of noradrenaline, the increase in heart rate could be totally prevented by cervical vagotomy.4. The time course of the increase in heart rate observed in the spinal animals was rapid, reaching maximum expression within 10 sec of pulmonary vein distension. Such a time course is dissimilar from that associated with pulmonary vein distension in intact or decerebrate dogs in which maximum increases in heart rate take 1-3 min to develop.5. It is concluded that the reflex tachycardia resulting from pulmonary vein distension may be mediated by both an efferent sympathetic and an efferent vagal pathway, the relative significance of each component being dependent upon the prevailing autonomic drive existent in the animal at any specific time.

Animals↗
PubMed2001

Outcome of intrathecal opioids in chronic non-cancer pain.

Eighty-eight patients (58 women and 30 men; mean age 53.4 years) with chronic non-cancer pain present on average for 9.8 years were evaluated following treatment with intrathecal opioids for an average duration of 36.2 months. Outcome measures were global pain relief, physical activity levels, medication consumption, work status, intrathecal opioid side-effects, proportion of patients who ceased therapy and patient satisfaction. The most common diagnosis in this group was lumbar spinal or radicular pain after failed spinal surgery (n= 55, 63%). At the time of follow-up, mean pain relief was 60% with 74% of patients (36 of 49) reporting increased activity levels. Oral medication intake was significantly reduced (Medication Quantification Scale Score prior to implantation 31.0+/-2.6 and at follow-up 12.7+/-1.4; n= 48; p< 0.0001). These gains were not accompanied by a change in work status (43 of 50 working age patients not working at follow-up). There were frequent reports of opioid side-effects, including sexual dysfunction and menstrual disturbance. Technical complications occurred with the drug administration device, most often catheter related, requiring at least one further surgical procedure in 32 patients (40%). Patient satisfaction with intrathecal opioids was high, with 45 of 51 (88%) reporting satisfaction. Mean intrathecal morphine dose increased from 9.95+/-1.49 mg/day (mean+/-SEM) at 6 months to 15.26+/-2.52 mg/day 36 months after initiation of therapy. Drug administration systems were permanently removed in five patients (6%). Intrathecal opioid therapy appears to have a place in the management of chronic non-cancer pain. Therapy does not seem to be significantly inhibited by the development of tolerance.

Activities of Daily Living↗
PubMed2000

Intrathecal baclofen for the treatment of dystonia in patients with reflex sympathetic dystrophy.

BACKGROUND AND METHODS: Patients with reflex sympathetic dystrophy (also known as the complex regional pain syndrome) may have dystonia, which is often unresponsive to treatment. Some forms of dystonia respond to the intrathecal administration of baclofen, a specific gamma-aminobutyric acid-receptor (type B) agonist that inhibits sensory input to the neurons of the spinal cord. We evaluated this treatment in seven women who had reflex sympathetic dystrophy with multifocal or generalized tonic dystonia. First, we performed a double-blind, randomized, controlled crossover trial of bolus intrathecal injections of 25, 50, and 75 microg of baclofen and placebo. Changes in the severity of dystonia were assessed by the woman and by an investigator after each injection. In the second phase of the study, six of the women received a subcutaneous pump for continuous intrathecal administration of baclofen and were followed for 0.5 to 3 years. RESULTS: In six women, bolus injections of 50 and 75 microg of baclofen resulted in complete or partial resolution of focal dystonia of the hands but little improvement in dystonia of the legs. During continuous therapy, three women regained normal hand function, and two of these three women regained the ability to walk (one only indoors). In one woman who received continuous therapy, the pain and violent jerks disappeared and the dystonic posturing of the arm decreased. In two women the spasms or restlessness of the legs decreased, without any change in the dystonia. CONCLUSIONS: In some patients, the dystonia associated with reflex sympathetic dystrophy responds markedly to intrathecal baclofen.

Adult↗
PubMed1996

Selective N-type neuronal voltage-sensitive calcium channel blocker, SNX-111, produces spinal antinociception in rat models of acute, persistent and neuropathic pain.

Male Sprague-Dawley rats were used to evaluate the antinociceptive properties of the selective N-type voltage-sensitive calcium channel (VSCC) blocker, SNX-111, when the compound is administered spinally by either bolus injection or continuous, constant-rate infusion into the subarachnoid space. SNX-111 produced significant, dose-dependent antinociceptive effects by suppressing both the acute (phase 1: ED50, 14 ng/hr) and tonic (phase 2: ED50, 0.82 ng/hr) phases of the formalin test when it was infused for 72 hr immediately before testing. Phase 2 nociceptive responses were suppressed by bolus injections of 100 ng SNX-111. SNX-111 was approximately 1000-fold more potent than morphine in blocking phase 2 responses when the compounds were administered by intrathecal bolus injection. In rats with an experimentally induced painful peripheral neuropathy, intrathecal bolus injections of 30 to 300 ng SNX-111 blocked mechanical allodynia in a dose-dependent manner. Subacute administration of SNX-111 (1, 10 and 100 ng/hr) by continuous intrathecal infusion produced a reversible blockade of mechanical allodynia without apparent development of tolerance. These results show that: 1) selective N-type VSCC blockers are potent and efficacious antinociceptive agents when they are administered by the spinal route; 2) selective N-type VSCC blockers are effective in rat models of acute, persistent and neuropathic pain; and 3) N-type VSCCs play a significant role in the spinal processing of noxious somatosensory input.

Analgesics↗
PubMed1990

Differential effects of C- and N-terminal substance P metabolites on the release of amino acid neurotransmitters from the spinal cord: potential role in nociception.

Extensive evidence implicates Substance P [SP(1-11)] as a primary afferent neurotransmitter or modulator of nociceptive information, and there is increasing evidence that the excitatory amino acids aspartate (Asp) and glutamate (Glu) may also act as nociceptive neurotransmitters. We have previously demonstrated that nociceptive stimulation (metatarsal injection of formalin) caused a tetrodotoxin (TTX)-sensitive release of Asp and a TTX-insensitive release of Glu from the dorsal spinal cord. We have also shown release of Asp and Glu following the direct infusion of SP(1-11), suggesting that formalin-induced Asp or Glu changes could be secondary to an initial release of SP(1-11). In contrast to nociception, pretreatment with TTX, reported here, had no effect on the SP(1-11)-induced release of Asp, suggesting a presynaptic mechanism. Behavioral experiments, in both our laboratory, and others, now suggest that the N-terminal products of SP metabolism play a distinct role in the modulation of SP(1-11) nociception, possibly through an interaction with an opiate receptor. To test the hypothesis that N- and C-terminal fragments of SP produce opposite effects on biochemical events potentially involved in nociception, we compared the effects of infusion of the N-terminal metabolite SP(1-7) and the C-terminal metabolite SP(5-11) on changes in the ECF concentration of amino acids in the spinal cord as a measure of their apparent release, using microdialysis. Intradiaylsate infusion of SP(5-11) increased the release of Asp, Glu, asparagine (Asn), glycine (Gly), and taurine (Tau). The changes in Asp, Glu, and Tau were similar in direction and magnitude to changes produced by SP(1-11) or formalin injection, further supporting the hypothesis that the C-terminal is responsible for the nociceptive effects of SP(1-11). In contrast, infusion of SP(1-7) significantly decreased the release of Asn, Tau, Glu, and Gly. This inhibition of amino acid release is consistent with the hypothesis that N-terminal metabolites produce opposite effects to those of C-terminal metabolites of SP(1-11). The decreases in Glu, Asn, Gly, and Tau following SP(1-7) infusion were significantly reduced by i.p. or intradialysate naloxone. Systemic naloxone had no significant effects on the SP(5-11)-induced amino acid changes; however, it did inhibit the SP(1-11)-induced increase in Asp and Glu. Intradialysate naloxone had no effect on the SP(1-11)-induced increases.(ABSTRACT TRUNCATED AT 400 WORDS)

Amino Acids↗
PubMed2006

Successful treatment of posttraumatic hemiballismus with intrathecal baclofen therapy.

Intrathecal baclofen (ITB) therapy is widely used in the management of spastic hypertonia and dystonia resulting from a multitude of conditions that present with upper motor neuron syndrome signs, such as cerebral palsy, stroke, brain and spinal injuries, and multiple sclerosis. We report successful management of posttraumatic hemiballismus and dystonia with ITB in a 43-yr-old man who sustained a traumatic brain injury secondary to an assault in 1978. He subsequently developed hemiballismus in the right lower limb and dystonia of the distal right upper limb spreading proximally to involve the shoulder. The ballistic movement of the lower limb was severe enough to cause the patient to fall out of his chair and limit his ability to perform activities of daily living safely. He had been on various oral medications and received botulinum toxin and phenol injections, but none alleviated the symptoms. The patient elected to receive the ITB pump. Before ITB, he had an average of 10-12 ballism episodes of the right lower limb per hour. During observed episodes, the right hip would flex up to about 90 degrees, with a fully extended knee. After ITB pump implantation and upward dose titration, the frequency of ballistic right leg movements decreased to about three per day, and the right hip flexed to only 30 degrees. In addition, there was increased ability to isolate individual distal joint movements in the right lower limb. The patient currently receives 202.4 microg/day ITB and continues to benefit almost 6 yrs after ITB pump implantation. This report highlights the emerging role of ITB in managing movement disorders other than dystonia spastic hypertonia and dystonia.

Adult↗
PubMed2004

Treatment of spasticity with intrathecal Baclofen administration: long-term follow-up, review of 40 patients.

STUDY DESIGN: Case series of a consecutive sample. Retrospective audit. OBJECTIVE: To analyze the long-term safety and efficacy of intrathecal baclofen (ITB), and technical incidents. SETTING: Neurosurgical and Physical Medicine Departments of two university hospitals in western France. METHODS: The medical records of 40 patients who underwent ITB pump placement for the treatment of severe chronic spasticity were reviewed. Patients were eligible independently of the origin of the spasticity (spinal cord origin 33, brain damage 8). They underwent a final assessment with clinical examination and questionnaire in 2001. Ashworth scale scores were assessed, patient satisfaction was rated on a visual analog scale (VAS), functional independence before and after treatment was classified as bed-ridden, wheelchair dependent or ambulant, and the frequency and nature of complications were noted. RESULTS: The average follow-up period was of 4 years. The average Ashworth score at the final assessment was 1.8+/-0.6. Average patients satisfaction was 7.4/10+/-2.21 on VAS. In all, 85% would have undergone the procedure again if they had to make the decision. In 85% of the cases the ambulation status was unchanged. Technical incidents occurred at least once in 37% of the patients (due to the catheter in 58% and to the pump in 42%). They included catheter disconnections (4), migration (4), kinks (3), obstruction (3), development of fibrosis (3), disconnection of pump reservoir (2), porosity of pump membrane (2), unexplained pump dysfunction (4) leakage, and subcutaneous collection (5). Severe pharmacological side effects requiring transfer to intensive care unit occurred in 12% of cases, 80% of which were directly related to pump refill procedures. CONCLUSION: ITB remained effective in the long term and patients were satisfied. Nevertheless, complications were frequent, involving mainly the catheters, which would require further technical improvements.

Adult↗