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

Ralf E. Gebhard, Tobias Moeller-Bertram, Douglas Dobecki, Feyce Peralta, Evan G. Pivalizza, Madhumani Rupasinghe, Sanja Ilic, Mark Hochman

Research output: Contribution to journalArticle

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 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.

Original languageEnglish (US)
Pages (from-to)1319-1327
Number of pages9
JournalAnesthesia and analgesia
Volume129
Issue number5
DOIs
StatePublished - Nov 1 2019

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Epidural Space
Fluoroscopy
Technology
Needles
Pain Management
Pressure
Chronic Pain
Odds Ratio
Confidence Intervals
Identification (Psychology)
Radiation
Epidural Injections
Anesthesia and Analgesia
Epidural Analgesia
Epidural Anesthesia
Standard of Care
Interpersonal Relations
Health Care Costs
Contrast Media
Catheters

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

Cite this

Objective Epidural Space Identification Using Continuous Real-Time Pressure Sensing Technology : A Randomized Controlled Comparison With Fluoroscopy and Traditional Loss of Resistance. / Gebhard, Ralf E.; Moeller-Bertram, Tobias; Dobecki, Douglas; Peralta, Feyce; Pivalizza, Evan G.; Rupasinghe, Madhumani; Ilic, Sanja; Hochman, Mark.

In: Anesthesia and analgesia, Vol. 129, No. 5, 01.11.2019, p. 1319-1327.

Research output: Contribution to journalArticle

Gebhard, Ralf E. ; Moeller-Bertram, Tobias ; Dobecki, Douglas ; Peralta, Feyce ; Pivalizza, Evan G. ; Rupasinghe, Madhumani ; Ilic, Sanja ; Hochman, Mark. / Objective Epidural Space Identification Using Continuous Real-Time Pressure Sensing Technology : A Randomized Controlled Comparison With Fluoroscopy and Traditional Loss of Resistance. In: Anesthesia and analgesia. 2019 ; Vol. 129, No. 5. pp. 1319-1327.
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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 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.",
author = "Gebhard, {Ralf E.} and Tobias Moeller-Bertram and Douglas Dobecki and Feyce Peralta and Pivalizza, {Evan G.} and Madhumani Rupasinghe and Sanja Ilic and Mark Hochman",
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T1 - Objective Epidural Space Identification Using Continuous Real-Time Pressure Sensing Technology

T2 - A Randomized Controlled Comparison With Fluoroscopy and Traditional Loss of Resistance

AU - Gebhard, Ralf E.

AU - Moeller-Bertram, Tobias

AU - Dobecki, Douglas

AU - Peralta, Feyce

AU - Pivalizza, Evan G.

AU - Rupasinghe, Madhumani

AU - Ilic, Sanja

AU - Hochman, Mark

PY - 2019/11/1

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N2 - 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.

AB - 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.

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