Continuous intrathecal baclofen administration by a fully implantable electronic pump for severe spasticity...

With this 8-month study, we wanted to evaluate the efficacy of continuous intrathecal baclofen infusion delivery by a programmable pump for severe spasticity according to patient selection criteria, implantation technique and related parameters, and outcome after the initial follow-up period.

Intrathecal baclofen infusion was initiated in 30 patients within 24 h after a test dose of the agent resulted positive in spinal anaesthesia. During the procedure and the follow-up period, the following parameters were measured: incidence of anaesthesiological or surgical complications and adverse events, postdural puncture headache, prolonged motor block, difficulty in wound healing, infection, necessity to remove the pump; clinical response as measured on the Ashworth and spasms scales, quality of sleep, autonomy, quality of life and pain before and after intrathecal baclofen therapy.

Perioperative vital parameters (mean duration of the operation, 86+/-13 min) were stable; no motor block or postdural puncture headache, early or late infection developed. The 1 case of delayed wound healing resolved with treatment; a dislocated catheter was repositioned in 1 other case. The differences in changes between pre- and posttreatment were statistically significant, with best results obtained on rigidity and pain. The mean length of hospital stay was 8+/-2 days. Baclofen tolerance was observed in 1 case, but resolved after baclofen holiday with morphine. One case of pump malfunctioning was resolved with replacement of the device; no new neurological deficits occurred thereafter.

The good clinical response to treatment of spasticity and rigidity, improved quality of life, pain reduction and patient satisfaction with short length of admission demonstrate the efficacy of intrathecal baclofen therapy. Safe and efficacious, this mode of treatment appears to be the gold standard for treating severe spasticity.