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腹腔镜检查后布比卡因局部麻醉药浸润至套管针插入部位:一项随机、双盲、分层和对照试验。

Infiltration of bupivacaine local anesthetic to trocar insertion sites after laparoscopy: a randomized, double-blind, stratified, and controlled trial.

作者信息

Tam Teresa, Harkins Gerald, Wegrzyniak Lindsey, Ehrgood Suzanne, Kunselman Allen, Davies Matthew

机构信息

Department of Obstetrics and Gynecology.

Department of Obstetrics and Gynecology.

出版信息

J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):1015-21. doi: 10.1016/j.jmig.2014.04.013. Epub 2014 May 2.

Abstract

STUDY OBJECTIVE

To determine if injection of local anesthetic into trocar insertion sites after laparoscopy improves postoperative pain.

DESIGN

A prospective, 2-arm, randomized, double-blind, stratified, and controlled trial (Canadian Task Force classification I).

SETTING

A university-based teaching hospital.

PATIENTS

This study was performed on women who had a laparoscopic gynecologic procedure for benign indications from March 2013 to June 2013. One hundred thirty-five subjects were stratified by chronic pelvic pain or no chronic pelvic pain. Chronic pelvic pain was defined as pelvic pain occurring for 6 months or more in duration. Randomization was performed for this trial, with 68 receiving a bupivacaine block and 67 receiving no bupivacaine block. Of the 71 patients with chronic pelvic pain, 35 patients were in group 1 (i.e., bupivacaine block) and 36 patients were in group 2 (i.e., no bupivacaine block).

INTERVENTIONS

After the laparoscopic surgery was completed, the trocar incision sites were closed. For subjects randomized to receive a local anesthesia block, bupivacaine (0.25%) was injected. Incisions 8 mm or greater were injected with 10 mL 0.25% bupivacaine. Incisions 5 mm or less were infiltrated with 5 mL. Injecting the local anesthetic through all preperitoneal layers provided a full-thickness local injection. Group 2 did not receive a local injection.

MEASUREMENTS AND MAIN RESULTS

At the preoperative suite, the nurses gauged the patient's pain using the Numeric Rating Scale. This score was used as the baseline pain level with which the postoperative pain scores were compared. The primary objective was to measure changes in pain scores, from preoperative to postoperative time frames of 2 to 4 hours, 6 to 8 hours, 18 to 24 hours, and 3 to 7 days postoperatively. These score changes were measured as the main objective. Secondary objectives include estimated blood loss, operating time, length of hospital stay, and histopathologic diagnosis. The hospital personnel caring for the patient during the preoperative and postoperative course were given standard pain evaluation protocols. All study pain evaluators and patients were blinded to treatment assignments throughout the pain assessment process. There were no statistically significant differences in patient characteristics between the 2 treatment groups. No significant difference was found in secondary outcomes including estimated blood loss, length of hospital stay, and histopathologic diagnosis. In general, Numeric Rating Scale pain scores were lower (i.e., less pain) in the "bupivacaine block" group compared with the "no bupivacaine" block group at the following postsurgery time assessments: 2 to 4 hours, 6 to 8 hours, 18 to 24 hours, and 3 to 7 days after surgery. However, the effect was not large enough (<1 point) to show a statistical difference between the treatment groups at any of these postsurgery assessments.

CONCLUSION

The postoperative injection of bupivacaine in trocar port sites did not significantly improve pain scores after laparoscopic gynecologic surgery.

摘要

研究目的

确定腹腔镜检查后在套管针穿刺部位注射局部麻醉剂是否能改善术后疼痛。

设计

一项前瞻性、双臂、随机、双盲、分层对照试验(加拿大工作组分类I级)。

地点

一所大学教学医院。

患者

本研究对2013年3月至2013年6月因良性指征接受腹腔镜妇科手术的女性进行。135名受试者按是否有慢性盆腔痛进行分层。慢性盆腔痛定义为持续6个月或更长时间的盆腔疼痛。对该试验进行随机分组,68人接受布比卡因阻滞,67人不接受布比卡因阻滞。在71例有慢性盆腔痛的患者中,35例在第1组(即布比卡因阻滞组),36例在第2组(即无布比卡因阻滞组)。

干预措施

腹腔镜手术完成后,关闭套管针切口部位。对于随机接受局部麻醉阻滞的受试者,注射布比卡因(0.25%)。8mm或更大的切口注射10mL 0.25%布比卡因。5mm或更小的切口注射5mL。通过所有腹膜前层注射局部麻醉剂可进行全层局部注射。第2组未接受局部注射。

测量指标及主要结果

在术前病房,护士使用数字评分量表评估患者疼痛程度。该评分用作术后疼痛评分比较的基线疼痛水平。主要目的是测量术前至术后2至4小时、6至8小时、18至24小时以及术后3至7天疼痛评分的变化。这些评分变化作为主要测量指标。次要指标包括估计失血量、手术时间、住院时间和组织病理学诊断。术前和术后护理患者的医院工作人员采用标准疼痛评估方案。在整个疼痛评估过程中,所有研究疼痛评估人员和患者均对治疗分配情况不知情。两个治疗组患者特征无统计学显著差异。在次要结果包括估计失血量、住院时间和组织病理学诊断方面未发现显著差异。总体而言,在术后以下时间评估中,“布比卡因阻滞”组的数字评分量表疼痛评分低于“无布比卡因”阻滞组(即疼痛较轻):术后2至4小时、6至8小时、18至24小时以及术后3至7天。然而,该效果不够大(<1分),在任何术后评估中均未显示治疗组之间存在统计学差异。

结论

腹腔镜妇科手术后在套管针穿刺部位注射布比卡因并未显著改善疼痛评分。

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