Treatment with prolonged-release oxycodone/naloxone improves pain relief and opioid-induced constipation compared with prolonged-release oxycodone in patients with chronic severe pain and laxative-refractory constipation.

PURPOSE: Laxative-refractory opioid-induced constipation (OIC) is defined as OIC despite using 2 laxatives with a different mechanism of action (based on the Anatomical Therapeutic Chemical Classification System level 4 term [contact laxatives, osmotically acting laxatives, softeners/emollients, enemas, and others]). OIC has a significant impact on the treatment and quality of life of patients with severe chronic pain. This noninterventional, observational, real-life study in Belgium investigated the efficacy of prolonged-release oxycodone/naloxone combination (PR OXN) treatment regarding pain relief and OIC compared with previous prolonged-release oxycodone (PR OXY) treatment for laxative-refractory OIC in daily clinical practice. METHODS: Laxative-refractory OIC patients with severe chronic pain were treated with PR OXN for 12 weeks (3 visits). Pain relief (assessed on a numerical rating scale) and OIC (assessed by using the Bowel Function Index [BFI]) were evaluated at each visit. A responder was defined as a patient who had: (1) no worsening of pain at the last visit compared with visit 1 or a numerical rating scale ≤4 at visit 3/last visit; and (2) a reduction in BFI ≥12 units at visit 3/last visit compared with visit 1; or (3) a BFI ≤28.8 at visit 3/last visit. FINDINGS: Sixty-eight laxative-refractory OIC patients with severe chronic pain (mean (sd) age 59.8 (13.3) years, 67.6% female and 91.2% non-malignant pain) were treated for 91 days with PR OXN (median daily dose, 20 mg). Treatment with PR OXN resulted in a significant and clinically relevant decrease of pain of 2.1 units (P < 0.001; 95% CI, 1.66-2.54) and of BFI by 48.5 units (P < 0.001; 95% CI, 44.4-52.7) compared with PR OXY treatment; use of laxatives was also significantly reduced (P < 0.001). Approximately 95% of patients were responders, and quality of life (as measured by using the EQ-5D) improved significantly. Adverse events were opioid related, and PR OXN treatment was well tolerated. IMPLICATIONS: Treatment with PR OXN resulted in a significant and clinically relevant reduction in OIC compared with previous PR OXY treatment for these patients with severe chronic pain and laxative-refractory OIC. Treatment with PR OXN also resulted in a significant improvement in pain relief and quality of life. ClinicalTrials.gov identifier: NCT01710917.

Long-term outcomes of spinal cord stimulation with percutaneously introduced paddle leads in the treatment of failed back surgery syndrome and lumboischialgia.

OBJECTIVE: The study aims to evaluate the long-term clinical and technical efficacy of recently developed percutaneously introducible plate electrodes for spinal cord stimulation. METHODS: Twenty-one patients diagnosed with failed back surgery syndrome (FBSS) or lumboischialgia were implanted with a small profile plate-type electrode. Patients were followed-up long term and were asked at baseline, after trial, and during each follow-up visit to score their pain on a visual analog scale (VAS) for pain now, worst pain last week, least pain last week, and mean pain last week. Pain location, electrophysiologic parameters, and number of reprogrammings were collected as well. Furthermore, each patient was asked if he/she would redo the procedure post trial and at each of the follow-up visits. RESULTS: A total of 21 patients were prospectively followed up long term. With a mean follow-up of 40.8 months, a significant mean reduction in patient self-reported pain from baseline to postoperative of 75.79% pain reduction was seen at follow-up 1 and 62.52% at follow-up 2. A significant decrease was obtained for, respectively, pain at the present moment, VAS pain worst last week, VAS pain least last week, and VAS pain mean last week in comparison with baseline VAS scores. All patients indicated that they would redo the procedure. CONCLUSION: Percutaneous implantation of small profile paddle leads in patients with FBSS and lumboischialgia produces favorable results over the long term that are at least comparable with surgical implanted paddle leads. The percutaneous approach also allows nonsurgically trained pain physicians to introduce paddle leads. Indices like if patients would redo the procedure may be more appropriate for analyzing long-term outcomes than the arbitrarily taking 50% reduction in VAS scores.

Technological innovation in spinal cord stimulation: use of a newly developed delivery device for introduction of spinal cord stimulation leads.

OBJECTIVE: The use of multiple cylindrical leads and multicolumn and single column paddle leads in spinal cord stimulation offers many advantages over the use of a single cylindrical lead. Despite these advantages, placement of multiple cylindrical leads or a paddle lead requires a more invasive surgical procedure. Thus, the ideal situation for lead delivery would be percutaneous insertion of a paddle lead or multiple cylindrical leads. This study evaluated the feasibility and safety of percutaneous delivery of S-Series paddle leads using a new delivery device called the Epiducer lead delivery system (all St. Jude Medical Neuromodulation Division, Plano, TX, USA). MATERIALS AND METHODS: This uncontrolled, open-label, prospective, two-center study approved by the AZ St. Lucas (Ghent) Ethics Committee evaluated procedural aspects of implantation of an S-Series paddle lead using the Epiducer lead delivery system and any adverse events relating to the device. Efficacy data during the patent's 30-day trial also were collected. RESULTS: Data from 34 patients were collected from two investigational sites. There were no adverse events related to the Epiducer lead delivery system. The device was inserted at an angle of either 20°-30° or 30°-40° and was entered into the epidural space at T12/L1 in most patients. The S-Series paddle lead was advanced four vertebral segments in more than 50% of patients. The average (±standard deviation [SD]) time it took to place the Epiducer lead delivery system was 8.7 (±5.0) min. The average (+SD) patient-reported pain relief was 78.8% (+24.1%). CONCLUSIONS: This study suggests the safe use of the Epiducer lead delivery system for percutaneous implantation and advancement of the S-Series paddle lead in 34 patients.

The epidural fibrous sheath: a guide for the replacement of a spinal cord stimulation electrode.

BACKGROUND AND OBJECTIVE: During spinal cord stimulation there is sometimes a need to replace defective leads. Percutaneous lead replacement by recannulating the epidural space and "steering" the new lead to the prior location is sometimes very difficult, resulting in diminished analgesia. Since fibrous deposits are known to form around epidural catheters and epidural obstructions have been noted with other techniques, we have inserted the new lead through the well-dissected opening in the interspinal ligament. We will report the results of our case series. METHODS: In 11 patients with lead malfunction we reinserted a new electrode into the epidural space by first withdrawing the lead with one hand and inserting the new one through the interspinal ligament with the other. In using this method, we found we could position the new electrode almost identically to the first. In only 3 patients did we experience difficulty in identifying the opening for the insertion. In the successfully cannulated patients identical stimulation parameters and paresthesia areas were obtained. By experimentally injecting contrast dye through an epidural catheter inserted into the interspinal opening and epidural pathway, we could visualize a thin dense line representing the fibrous sheath. CONCLUSION: Foreign bodies in the epidural space lead to fibrous deposits. Spinal cord stimulation, when those deposits form a sheath, the sheath is useful for lead revision. The procedure, if meticulously performed, has a high success rate.