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阴道手术中术后使用颠茄和鸦片直肠栓剂的随机对照试验。

Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery.

作者信息

Butler Kristina, Yi John, Wasson Megan, Klauschie Jennifer, Ryan Debra, Hentz Joseph, Cornella Jeffrey, Magtibay Paul, Kho Roseanne

机构信息

Department of Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ.

Department of Gynecologic Surgery, Mayo Clinic Arizona, Phoenix, AZ.

出版信息

Am J Obstet Gynecol. 2017 May;216(5):491.e1-491.e6. doi: 10.1016/j.ajog.2016.12.032. Epub 2016 Dec 28.

DOI:10.1016/j.ajog.2016.12.032
PMID:28040448
Abstract

BACKGROUND

After vaginal surgery, oral and parenteral narcotics are used commonly for pain relief, and their use may exacerbate the incidence of sedation, nausea, and vomiting, which ultimately delays convalescence. Previous studies have demonstrated that rectal analgesia after surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium rectal suppositories may be used to relieve pain and minimize side effects; however, their efficacy has not been confirmed.

OBJECTIVE

We aimed to evaluate the use of belladonna and opium suppositories for pain reduction in vaginal surgery.

MATERIALS AND METHODS

A prospective, randomized, double-blind, placebo-controlled trial that used belladonna and opium suppositories after inpatient or outpatient vaginal surgery was conducted. Vaginal surgery was defined as (1) vaginal hysterectomy with uterosacral ligament suspension or (2) posthysterectomy prolapse repair that included uterosacral ligament suspension and/or colporrhaphy. Belladonna and opium 16A (16.2/60 mg) or placebo suppositories were administered rectally immediately after surgery and every 8 hours for a total of 3 doses. Patient-reported pain data were collected with the use of a visual analog scale (at 2, 4, 12, and 20 hours postoperatively. Opiate use was measured and converted into parenteral morphine equivalents. The primary outcome was pain, and secondary outcomes included pain medication, antiemetic medication, and a quality of recovery questionnaire. Adverse effects were surveyed at 24 hours and 7 days. Concomitant procedures for urinary incontinence or pelvic organ prolapse did not preclude enrollment.

RESULTS

Ninety women were randomly assigned consecutively at a single institution under the care of a fellowship-trained surgeon group. Demographics did not differ among the groups with mean age of 55 years, procedure time of 97 minutes, and prolapse at 51%. Postoperative pain scores were equivalent among both groups at each time interval. The belladonna and opium group used a mean of 57 mg morphine compared with 66 mg for placebo (P=.43) in 24 hours. Patient satisfaction with recovery was similar (P=.59). Antiemetic and ketorolac use were comparable among groups. Subgroup analyses of patients with prolapse and patients <50 years old did not reveal differences in pain scores. The use of belladonna and opium suppositories was uncomplicated, and adverse effects, which included constipation and urinary retention, were similar among groups.

CONCLUSION

Belladonna and opium suppositories are safe for use after vaginal surgery. Belladonna and opium suppositories did not reveal lower pain or substantially lower narcotic use. Further investigation may be warranted to identify a population that may benefit optimally from belladonna and opium use.

摘要

背景

阴道手术后,常用口服和胃肠外麻醉剂来缓解疼痛,但其使用可能会增加镇静、恶心和呕吐的发生率,最终延缓康复。先前的研究表明,术后直肠镇痛可降低疼痛评分,并减少静脉注射吗啡的用量。颠茄鸦片直肠栓剂可用于缓解疼痛并将副作用降至最低;然而,其疗效尚未得到证实。

目的

我们旨在评估颠茄鸦片栓剂在阴道手术中减轻疼痛的作用。

材料与方法

开展了一项前瞻性、随机、双盲、安慰剂对照试验,在住院或门诊阴道手术后使用颠茄鸦片栓剂。阴道手术定义为:(1)子宫骶骨韧带悬吊式阴道子宫切除术;或(2)子宫切除术后脱垂修复术,包括子宫骶骨韧带悬吊术和/或阴道壁修补术。术后立即经直肠给予16A颠茄鸦片栓剂(16.2/60毫克)或安慰剂栓剂,每8小时给药一次,共给药3次。使用视觉模拟量表收集患者报告的疼痛数据(术后2、4、12和20小时)。测量阿片类药物的使用量并换算成胃肠外吗啡当量。主要结局为疼痛,次要结局包括止痛药物、止吐药物及恢复质量问卷。在术后24小时和7天调查不良反应。伴有尿失禁或盆腔器官脱垂的相关手术不影响入组。

结果

在一个由专科培训外科医生团队负责的单一机构中,90名女性被连续随机分组。各分组的人口统计学特征无差异,平均年龄55岁,手术时间97分钟,脱垂发生率为51%。两组在各时间间隔的术后疼痛评分相当。颠茄鸦片组在24小时内平均使用吗啡57毫克,而安慰剂组为66毫克(P = 0.43)。患者对恢复情况的满意度相似(P = 0.59)。两组间止吐药和酮咯酸的使用情况相当。对脱垂患者和年龄<50岁患者的亚组分析未发现疼痛评分有差异。使用颠茄鸦片栓剂的过程无并发症,包括便秘和尿潴留在内的不良反应在两组间相似。

结论

颠茄鸦片栓剂在阴道手术后使用是安全的。颠茄鸦片栓剂并未显示出更低的疼痛程度或显著更低的麻醉剂使用量。可能有必要进一步研究,以确定能从使用颠茄鸦片中获得最大益处的人群。

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