COMPLICATIONS OF INTRATHECAL OPIOIDS AND BUPIVACAINE IN THE TREATMENTOF REFRACTORY CANCER PAIN

Objective: To test the concept that externalized tunneled intrathecal catheters lead to a high risk of complications, such as meningitis and epidural abscess, and therefore should not be used for durations of i ntrathecal pain treatment of >1 week. Design: Prospective, cohort, non randomized, consecutive, historical control trial. Setting: Tertiary c are center, institutional practice, hospitalized and ambulatory care. Patients: Two hundred adults (107 women, 93 men) with refractory cance r pain treated for 1-575 (median, 33; total, 14,485) days; 79 patients were treated at home for 2-226 (median, 36; total, 4,711) days. All p atients had died by the close of the study. Interventions: Insertion o f intrathecal tunneled nylon (Porter) catheters (223 in 200 patients) with Millipore filters. The catheter hubs were securely fixed to the s kin with steel sutures. Standardized care after insertion: (a) daily p hone contact with the patients, their families, or the nurses in charg e; (b) weekly dressing change at the tunnel outlet by the nurses; (c) refilling of the infusion containers by the nurses; (d) exchange of th e infusion systems when empty (within 1 month) and of the antibacteria l filter once a month by specially instructed Pain Department nurses. All contact between the connections of the syringes, cassettes, and ne edles with the operator's hands was carefully avoided during filling a nd refilling of the infusion containers and exchange of the antibacter ial filters; no other aseptic precautions were taken. Main Outcome Mea sures: We recorded the rates of perfect function and complications of the systems. The rates of complications recorded in this study with ex ternalized tunneled intrathecal catheters are discussed and compared w ith the rates reported in the literature with externalized (tunneled a nd nontunneled) epidural and intrathecal catheters, as well as with in ternalized (both epidural and intrathecal) catheters connected to subc utaneous ports, reservoirs,and pumps. Results: The following rates (as a percentage of number of patients) of perfect function and complicat ions of the systems were recorded (the ranges of rates reported in the literature are given in parentheses): perfect function of the system, 93% (31-90%); accidental injury of an unknown epidural tumor followed by an epidural hematoma, 0.5% (0-6%); skin breakdown at the insertion site, 2% (2-50%); postdural puncture headache, 15.5% (10%); external leakage of CSF, 3.5% (4-27%); CSF hygroma (''pseudomeningocele''), 1.5 % (4-6.25%); hearing loss and Meniere-like syndrome, 0% (12%); pain on injection, 0% with continuous infusion and 4.5% with intermittent inj ections (3-36% with intermittent injections); catheter tip dislodgemen t, 1.5% (6-33%); catheter (system) occlusion, 1% (3-12%); accidental c atheter withdrawal, 4% (3-22%); catheter (system) leakage, 1.5% (2.1-2 6.6%); all mechanical complications, 8.5% (10-44%); local (catheter en try site) infection, 0.5% (2-33%); catheter track infection, 0% (6-25% ); epidural abscess, 0% (0.6-25%); meningitis, 0.5% (1-25%); systemic infection, 0% (3%); incidence of ail infections (n/treatment days), 1/ 7,242 (1/168-1/2,446). Conclusions: In our population and with the tec hnique of insertion and care reported here, the use of externalized tu nneled intrathecal catheters has not been associated with higher rates of complications when compared with earlier reported rates of externa lized epidural catheters and internalized (both epidural and intrathec al) catheters connected to subcutaneously implanted ports, reservoirs, and pumps. The opinion that the use of externalized tunneled intrathe cal catheters should be restricted only to patients who need pain trea tment for <1 week (because of the potential risk of infection, particu larly meningitis and epidural abscess) is unfounded.