Objective Epidural Space Identification Using Continuous Real-Time Pressure Sensing Technology: A Randomized Controlled Comparison With Fluoroscopy and Traditional Loss of Resistance

BACKGROUND: Performance of epidural anesthesia and analgesia depends on successful identification of the epidural space (ES). While multiple investigations have described objective and alternative methodologies to identify the ES, traditional loss of resistance (LOR) and fluoroscopy (FC) are currently standard of care in labor and delivery (L&D) and chronic pain (CP) management, respectively. While FC is associated with high success, it exposes patients to radiation and requires appropriate radiological equipment. LOR is simple but subjective and consequently associated with higher failure rates. The purpose of this investigation was to compare continuous, quantitative, real-time, needle-tip pressure sensing using a novel computer-controlled ES identification technology to FC and LOR for lumbar ES identification. METHODS: A total of 400 patients were enrolled in this prospective randomized controlled noninferiority trial. In the CP management arm, 240 patients scheduled to receive a lumbar epidural steroid injection had their ES identified either with FC or with needle-tip pressure measurement. In the L&D arm, 160 female patients undergoing lumbar epidural catheter placements were randomized to either LOR or needle-tip pressure measurement. Blinded observers determined successful ES identification in both arms. A modified intention-to-treat protocol was implemented, with patients not having the procedure for reasons preceding the intervention excluded. Noninferiority of needle-tip pressure measurement regarding the incidence of successful ES identification was claimed when the lower limit of the 97.27% confidence interval (CI) for the odds ratio (OR) was above 0.50 (50% less likely to identify the ES) and P value for noninferioirty <.023. results: demographics were similar between procedure groups with a mild imbalance in relation to gender when evaluated through standardized difference. noninferiority of needle-tip pressure measurement was demonstrated fc where pain management patients presented success rate es identification both methodologies ci p=".021" for and l experienced noninferior the novel technology vs or using priori delta conclusions: objective lumbar continuous quantitative real-time compuflo epidural computer controlled anesthesia system resulted rates compared lor cp respectively. benefits this may include nonexposure radiation contrast medium consequently reduced health care costs. accepted publication september funding: clinical trial funded by milestone scientific livingston nj. conflicts interest: see disclosures at end article. number: nct02378727 clinicaltrials.gov. reprints will not be available from authors. address correspondence ralf e. gebhard md department anesthesiology university miami miller school medicine nw ave c-300 fl e-mail rgebhard international research society>

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