Ralf E Gebhard1, Tobias Moeller-Bertram2, Douglas Dobecki3, Feyce Peralta4, Evan G Pivalizza5, Madhumani Rupasinghe5, Sanja Ilic6, Mark Hochman7. 1. From the Department of Anesthesiology, University of Miami, Miller School of Medicine, Miami, Florida. 2. Desert Clinic Pain Institute, Rancho Mirage, California. 3. San Diego Pain Institute, San Diego, California. 4. Department of Anesthesiology, Northwestern University, Chicago, Illinois. 5. Department of Anesthesiology, University of Texas, McGovern Medical School, Houston, Texas. 6. CRQ Management Solutions, Carlsbad, California. 7. Department of Restorative Dentistry, Stony Brook School of Dental Medicine, New York, New York.
Abstract
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 alumbar 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 a standardized difference. Noninferiority of needle-tip pressure measurement was demonstrated in relation to FC where pain management patients presented a 100% success rate of ES identification with both methodologies (OR, 1.1; 97.27% CI, 0.52-8.74; P = .021 for noninferiority), and L&D patients experienced a noninferior success rate with the novel technology (97.1% vs 91%; OR, 3.3; 97.27% CI, 0.62-21.54; P = .019) using a a priori noninferiority delta of 0.50. CONCLUSIONS: Objective lumbar ES identification using continuous, quantitative, real-time, needle-tip pressure measurement with the CompuFlo Epidural Computer Controlled Anesthesia System resulted in noninferior success rates when compared to FC and LOR for CP management and L&D, respectively. Benefits of this novel technology may include nonexposure of patients to radiation and contrast medium and consequently reduced health care costs.
RCT Entities:
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 a standardized difference. Noninferiority of needle-tip pressure measurement was demonstrated in relation to FC where pain management patients presented a 100% success rate of ES identification with both methodologies (OR, 1.1; 97.27% CI, 0.52-8.74; P = .021 for noninferiority), and L&D patients experienced a noninferior success rate with the novel technology (97.1% vs 91%; OR, 3.3; 97.27% CI, 0.62-21.54; P = .019) using a a priori noninferiority delta of 0.50. CONCLUSIONS: Objective lumbar ES identification using continuous, quantitative, real-time, needle-tip pressure measurement with the CompuFlo Epidural Computer Controlled Anesthesia System resulted in noninferior success rates when compared to FC and LOR for CP management and L&D, respectively. Benefits of this novel technology may include nonexposure of patients to radiation and contrast medium and consequently reduced health care costs.