IMPLEMENTATION OF A HUB PROTOCOL FOR REDUCING COMPLICATIONS IN SPINAL CORD AND DORSAL ROOT GANGLION STIMULATION: REAL-WORLD EXPERIENCE FROM THE EASTERN SICILY PAIN MANAGEMENT HUB CENTER

S. Zappalà¹, S. Stimolo², M. Maria³, S. Brundo³, S. Caramma³ | ¹Università di padova, Padova, Italy; ²Università di Padova, Italy; ³Policlinico G. Rodolico- San Marco, Catania, Italy

Introduction. Spinal cord stimulation (SCS) and dorsal root ganglion stimulation (DRGS) are cornerstones of neuromodulation for refractory chronic neuropathic pain. However, these procedures historically carry non-negligible infectious (3%–6%), neurological (2.31%), and mechanical complication rates that jeopardize efficacy and increase healthcare costs. This study evaluates the efficacy and safety of a standardized, multiphasic institutional protocol implemented at the Hub Center of Catania to minimize such adverse events in real-world practice.
Methods. A retrospective observational study (January 2024–June 2025) evaluated 66 patients undergoing definitive SCS/DRGS implantation after a 30-day trial phase with >50% pain relief. The institutional protocol standardized three main phases: Pre-operative Phase Comprehensive clinical assessment, including psychological and functional evaluation for clinical eligibility , metabolic optimization (fasting glucose <180 mg/dl, smoking cessation ≥ 4 weeks, BMI <35). Neuroanatomical eligibility via CT/MRI required a posterior epidural space and lateral recess width >3 mm. Antithrombotic therapy was managed per NACC/INS guidelines, alongside S. aureus nasal PCR screening and antiseptic showers. Intra-operative & Surgical Phase: Antibiotic prophylaxis, chlorhexidine skin antisepsis, and a double-glove technique before handling the implantable pulse generator (IPG). Leads were placed fluoroscopically via a paramedian epidural approach. Device stability was secured using active anchors, deep fascial silk sutures, and an epifascial strain-relief loop. The IPG pocket was tailored precisely to eliminate dead spaces, followed by layered anatomical closure (deep interrupted and intradermal sutures). Post-operative Phase: Wound care, patient/caregiver education, and clinical/telemetric follow-ups at 7, 14, 21, and 30 days (definitive implant, T1), 3 months (T2), 6 months (T3), and 1 year (T4).
Results. The cumulative 1-year (T4) complication rate was 3.03% (n=2/66). Both superficial and deep surgical site infections were 0%, showing a statistically significant reduction compared to historical data (p<0.05). Neurological, hemorrhagic, and CSF leak complications were also 0%. Adverse events were exclusively mechanical (3.03%, n=2): one DRGS electrode fracture at T3 due to trauma, and one SCS lead migration at T4 following a domestic accident. The rate of intrinsic complications directly attributable to failures in the standardized clinical pathway was 0%.
Conclusions. Systematic application of an evidence-based, standardized HUB protocol eliminates clinical variability, reducing intrinsic procedural complications to near-zero levels while maximizing patient safety and healthcare efficiency.