NEW SHEATH FOR VASCULAR ACCESS AND SUBCUTANEOUS DRUG ADMINISTRATION -MULTICENTER CLINICAL-TRIAL FOR PAIN PREVENTION AFTER CARDIAC-CATHETERIZATION

A new vascular sheath design (anesthesia infusion sleeve, or AIS) was developed to enable administration of local anesthetics or other medic ations into the subcutaneous tissue around an arterial or venous inser tion 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 rand omized 80 patients to use of a standard sheath for vascular access or the AIS. Pain associated with sheath placement, postprocedure pain, an d pain associated with sheath removal before and during manual compres sion was recorded. Baseline pain was identical in both the standard an d AIS groups. Pain during infiltration and with initial femoral artery compression was significantly lower in the AIS group. A quality of li fe questionnaire indicated that the AIS sheath was associated with les s discomfort and was preferred over a standard sheath in patients who had had a previous procedure performed. The AIS represents a simple ad dition to standard sheath design, offering superior pain control durin g removal compared to the standard technique, without the need for sys temic analgesics or additional needle punctures. (C) 1997 Wiley-Liss, Inc.