A Prospective, Multi-Center, Clinical Trial of a 10-kHz Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain.

BACKGROUND: Chronic pelvic pain (CPP) is a debilitating condition that often leads to disability and does not respond to conventional treatments. This study was conducted to evaluate the effects of paresthesia-independent 10-kHz spinal cord stimulation (SCS) in subjects with CPP. METHODS: This prospective, single-arm pilot study enrolled subjects with clinical diagnoses of CPP and mean pain scores of ≥ 5.0 cm on a 10-cm VAS. Subjects underwent trial stimulations with 10-kHz SCS, and those who had successful trial stimulations (≥40% pain relief) received permanently implanted devices and were followed for 12 months. RESULTS: Of the 21 subjects who underwent the 10-kHz SCS trial, 17 were successful and 14 subjects received permanent implants. No neurological deficits were observed in any subjects and all adverse events (AEs) were resolved without sequelae during the study period. Over 12 months, mean VAS scores decreased by 72% from baseline, and 10 of 13 subjects (77%) were responders (≥50% pain relief). Pain remission (VAS score ≤ 3.0 cm) was reported by 8 of 13 subjects (62%), and mean pain scores on the short-form McGill Pain Questionnaire 2 decreased as well. Pain Disability Index scores declined by 29 points, and 85% of the subjects reported satisfaction. CONCLUSIONS: Paresthesia-independent stimulation with 10-kHz SCS reduced pelvic pain in subjects with CPP and was not associated with any unexpected AEs. While larger, controlled studies are needed, results of this study suggest that this therapeutic modality could potentially treat patients with CPP while improving their quality of life.

Adverse events of conscious sedation in ambulatory spine procedures.

BACKGROUND CONTEXT: Interventional spine procedures are commonly performed in the ambulatory surgical setting, often using conscious sedation. The rate of adverse events with conscious sedation has not been previously assessed in the interventional spine procedure setting. PURPOSE: The goal of this study was to determine the rate of adverse events when using conscious sedation in the ambulatory interventional spine setting. STUDY DESIGN: A retrospective cohort chart review analysis was performed on all interventional spine procedures performed during one calendar year at a university-affiliated ambulatory surgery center by six nonanesthesia-trained spine interventionalists. PATIENT SAMPLE: Of the 3,342 procedures performed that year, 2,494 charts (74.6%) were available for review. OUTCOME MEASURES: Adverse events were documented immediately after the procedure and at a maximum 3-day follow-up phone call. METHODS: The rate and type of adverse events were analyzed and compared between those who received conscious sedation with local anesthesia and those who received local anesthesia alone. RESULTS: Of the 2,494 cases reviewed, 1,228 spine procedures were performed with local anesthesia and conscious sedation, and 1,266 procedures were performed with local anesthesia alone. Of these cases, 66 immediate adverse events (5.12%) were documented in the conscious sedation group, and 61 immediate adverse events (4.82%) were documented in the local anesthesia alone group. At maximum 3-day follow-up, 670 patients of the conscious sedation group were available for contact, and 699 patients were available from the local anesthesia group. Thirty-two adverse events (4.77%) were noted in the conscious sedation group, and 28 adverse events (4.00%) were noted in the local anesthesia group. Comparison of these rates found no significant statistical difference. However, patients in the local anesthesia group had a significantly higher rate of postoperative hypertension. Adverse events reported both immediately and at follow-up were determined to be mild, with no serious adverse events reported. CONCLUSION: The findings of this study suggest that mild to moderate conscious sedation in interventional spine procedures is associated with low rates of adverse events when established protocols are followed.