Thomas John A, Pan Peter H, Harris Lynne C, Owen Medge D, D'Angelo Robert
Department of Anesthesiology, Wake Forest University School of Medicine, Winston-Salem, NC 27157-1009, USA.
Anesthesiology. 2005 Nov;103(5):1046-51. doi: 10.1097/00000542-200511000-00019.
This prospective, double-blind, randomized study was designed to examine whether the combined spinal-epidural technique without subarachnoid drug administration improved epidural catheter function when compared with the traditional epidural technique.
After institutional review board approval and informed consent, 251 healthy laboring parturients were randomly assigned to either group DP (combined spinal-epidural technique with 27-gauge Whitacre needle dural puncture but without subarachnoid drug administration) or group NoDP (traditional epidural technique). Patient-controlled epidural analgesia was initiated with 0.11% bupivacaine and 2 microg/ml fentanyl. Top-up doses in 5-ml increments of 0.25% bupivacaine were administered if needed. Previous power analysis revealed that a sample size of 108 patients/group was needed to show a clinically useful reduction of the catheter manipulation rate from 32% to 15%.
In groups DP and NoDP, 107 and 123 evaluable patients, respectively, completed the study. Demographics and outcome variables measured, including epidural catheter manipulation and replacement rate, sacral sparing, unilateral block, number of top-up doses, average hourly epidural drug usage, highest sensory blockade level, and labor analgesia quality, were not different between groups. A subgroup of 18 patients without cerebral spinal fluid return during dural puncture had a higher catheter replacement rate than those of groups DP and NoDP, but it did not reach statistical significance.
Dural puncture with a 27-gauge Whitacre needle without subarachnoid drug administration during combined spinal-epidural labor analgesia did not improve epidural labor analgesia quality or reduce catheter manipulation or replacement rate when compared with a traditional epidural technique.
本前瞻性、双盲、随机研究旨在探讨与传统硬膜外技术相比，不进行蛛网膜下腔给药的腰麻-硬膜外联合技术是否能改善硬膜外导管功能。
经机构审查委员会批准并获得知情同意后，251名健康的分娩产妇被随机分为DP组（使用27G Whitacre针进行硬膜穿刺的腰麻-硬膜外联合技术，但不进行蛛网膜下腔给药）或NoDP组（传统硬膜外技术）。采用0.11%布比卡因和2μg/ml芬太尼启动患者自控硬膜外镇痛。必要时以5ml递增剂量追加0.25%布比卡因。先前的效能分析显示，每组需要108例患者的样本量才能显示导管操作率从32%临床有用地降低至15%。
DP组和NoDP组分别有107例和123例可评估患者完成了研究。所测量的人口统计学和结局变量，包括硬膜外导管操作和更换率、骶部保留、单侧阻滞、追加剂量次数、平均每小时硬膜外药物用量、最高感觉阻滞平面以及分娩镇痛质量，两组之间无差异。硬膜穿刺时未出现脑脊液回流的18例患者亚组的导管更换率高于DP组和NoDP组，但未达到统计学意义。
与传统硬膜外技术相比，在腰麻-硬膜外联合分娩镇痛期间使用27G Whitacre针进行硬膜穿刺且不进行蛛网膜下腔给药，并未改善硬膜外分娩镇痛质量，也未降低导管操作或更换率。
