(102) Real-time epidural space identification with the Compuflo® epidural instrument is equivalent to loss of resistance technique coupled with the fluoroscopy confirmation

Abstract

Success of the epidural technique depends upon the correct identification of the epidural space (ES). The incidence of difficult epidural catheter placement and early failure is significantly more likely among the morbidly obese population. The increased amount of subcutaneous and epidural fat in the obese population can pose a significant challenge to successful epidural catheter placement. After IRB approval and under United States Food and Drug Administration Investigations Device Exemption, a total of 400 patients were scheduled to receive epidural needle placement, as part of their medical management, and were enrolled in prospective controlled multi-center trial. Patients were randomized to either have the ES identified by standard of care methods utilizing either Loss of Resistance Technique (LOR) or by utilizing real-time pressure measurement at the epidural needle tip via the CompuFlo® Epidural Instrument (EP Group). A blinded independent observer evaluated correct identification of the ES defined as correct spread of dye demonstrated by fluoroscopy. This is a preliminary report of 70 subject whose Body Mass Index exceeded 31 Kg/m2. Groups were similar in terms of demographics, average age 49.4 and 52.5 . Identification of the ES in Group EP resulted in equal success rates and number of required attempts as in Group SC (100%and 1) p=0.78 –NS). No evidence of clinically significant adverse events was seen in any patient. This initial data suggest that identification of the ES by utilizing a computerized injection pump technology and obtaining real-time pressure measurements from the needle tip, results in equivalent success rate and safety when compared to fluoroscopy. This compact and mobile technology may have the potential to avoid exposure of the patient to radiation without compromising procedure effectiveness. This study was implemented under US FDA IDE sponsored by Milestone Scientific, Inc. Success of the epidural technique depends upon the correct identification of the epidural space (ES). The incidence of difficult epidural catheter placement and early failure is significantly more likely among the morbidly obese population. The increased amount of subcutaneous and epidural fat in the obese population can pose a significant challenge to successful epidural catheter placement. After IRB approval and under United States Food and Drug Administration Investigations Device Exemption, a total of 400 patients were scheduled to receive epidural needle placement, as part of their medical management, and were enrolled in prospective controlled multi-center trial. Patients were randomized to either have the ES identified by standard of care methods utilizing either Loss of Resistance Technique (LOR) or by utilizing real-time pressure measurement at the epidural needle tip via the CompuFlo® Epidural Instrument (EP Group). A blinded independent observer evaluated correct identification of the ES defined as correct spread of dye demonstrated by fluoroscopy. This is a preliminary report of 70 subject whose Body Mass Index exceeded 31 Kg/m2. Groups were similar in terms of demographics, average age 49.4 and 52.5 . Identification of the ES in Group EP resulted in equal success rates and number of required attempts as in Group SC (100%and 1) p=0.78 –NS). No evidence of clinically significant adverse events was seen in any patient. This initial data suggest that identification of the ES by utilizing a computerized injection pump technology and obtaining real-time pressure measurements from the needle tip, results in equivalent success rate and safety when compared to fluoroscopy. This compact and mobile technology may have the potential to avoid exposure of the patient to radiation without compromising procedure effectiveness. This study was implemented under US FDA IDE sponsored by Milestone Scientific, Inc.