Spinal anesthesia performance conditions and side effects are comparable between the newly designed Ballpen and the Sprotte needle: results of a prospective comparative randomized multicenter study.

Abstract

In this study, we examined the characteristics of a newly designed spinal needle (Ballpen [B]) with a pencil-like tip formed by a stylet that is withdrawn after penetration of the dura. The main goal was to examine whether the use of the B needle could reduce performance time by improved puncture conditions in comparison with the Sprotte (S) needle. Seven-hundred patients at 4 hospitals received single-dose spinal anesthesia with a 25-gauge B or S needle and 0.5% bupivacaine. The performance time of spinal anesthesia was defined as the time between insertion of the introducer needle and the first identification of cerebrospinal fluid in the hub of the spinal needle. Failed spinals were assessed when patients required general anesthesia. On postoperative Day 2-4, all patients were visited and interviewed. Groups did not differ with respect to demographics, puncture site, and dose of bupivacaine. Performance time was 98 +/- 145 s in Group B and 103 +/- 159 s in Group S (P = 0.68). The failure rate in Groups B and S was 3.8% and 3.9%, respectively, and the incidence of postdural puncture headache was 1.8% and 0.9% (P = 0.50), respectively. We conclude that there was no difference in technical variables or outcome between the B and S needles. This multicenter study examined characteristics of the newly designed Ballpen needle with the Sprotte needle in 700 patients undergoing lower abdominal or extremity surgery in single-dose spinal anesthesia. Technical variables and side effects were comparable between both noncutting spinal needles.