New sheath for vascular access and subcutaneous drug administration: Multicenter clinical trial for pain prevention after cardiac catheterization

Abstract

A new vascular sheath design (anesthesia infusion sleeve, or AIS) was developed to enable administration of local anesthetics or other medications into the subcutaneous tissue around an arterial or venous insertion site without any additional needle sticks or manipulation. Design, animal testing, and an initial small single-site clinical study have previously been published. The current study was multicenter and randomized 80 patients to use of a standard sheath for vascular access or the AIS. Pain associated with sheath placement, postprocedure pain, and pain associated with sheath removal before and during manual compression was recorded. Baseline pain was identical in both the standard and AIS groups. Pain during infiltration and with initial femoral artery compression was significantly lower in the AIS group. A quality of life questionnaire indicated that the AIS sheath was associated with less discomfort and was preferred over a standard sheath in patients who had had a previous procedure performed. The AIS represents a simple addition to standard sheath design, offering superior pain control during removal compared to the standard technique, without the need for systemic analgesics or additional needle punctures. Cathet Cardiovasc Diagn 40:81–83, 1997. © 1997 Wiley-Liss, Inc.