经皮神经电刺激用于 83 天妊娠以内的人工流产疼痛管理：一项随机对照试验。

Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial.

机构信息

Division of Family Planning Services and Research, Department of Obstetrics and Gynecology, School of Medicine, Stanford University, Stanford, California.

出版信息

Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.

DOI:10.1097/AOG.0000000000004502

PMID:34352845

Abstract

OBJECTIVE

To evaluate high-frequency, high-intensity transcutaneous electrical nerve stimulation (TENS) as an inexpensive, noninvasive pain management approach for first-trimester aspiration abortion.

METHODS

We conducted a noninferiority, single-blind, randomized controlled trial of patients seeking aspiration abortion at up to 83 days of gestation. Participants received TENS (placed posteriorly, T10-L1 and S2-S4) or intravenous (IV) sedation (fentanyl, midazolam). The primary outcome was pain with aspiration, as self-reported by visual analog scale (VAS, 100 mm). To detect at least a 15 mm mean difference on the 100 mm VAS with 90% power and a significance level of .05, a total of 90 participants were required.

RESULTS

Between January 2018 and October 2019, we enrolled 109 participants (55 TENS, 54 IV). Participant median gestation was 53 days (range 36-82) in the TENS group and 58 days (range 35-82) in the IV group (P=.65). Group demographics and clinical histories were similar. Intention-to-treat analysis (n=109) yielded noninferior results for the primary outcome (mean difference 4.8 mm, 95% CI -5.9 to 13.5 mm). In the per-protocol analysis, 9 (16%) in the TENS group were excluded after receiving IV sedation; 100 participants were included (46 TENS, 54 IV). Median (range) reported VAS for aspiration was 73 mm (13-97) and 66 mm (0-99) in the TENS and IV groups, respectively (P=.40). With a mean difference of 4.4 mm (95% CI -5.6 to 14.5 mm), we found TENS to be noninferior to IV. Physicians underestimated participant pain, perceiving pain to be 34 mm (6-91) in the TENS group and 25 mm (0-83) in the IV group (P=.003).

CONCLUSION

We found TENS to be a noninferior alternative to IV sedation for aspiration pain during first-trimester abortion. Expanding pain management options can improve quality of and access to abortion. Transcutaneous electrical nerve stimulation could be a standalone or adjunct approach for abortion pain management for those without access to or are ineligible to receive IV sedation due to the lack of sedation practitioner, designated driver, or local restrictions.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, NCT03187002.

摘要

目的

评估高频高强度经皮神经电刺激（TENS）作为一种廉价、非侵入性的疼痛管理方法，用于治疗孕早期吸宫术。

方法

我们进行了一项非劣效性、单盲、随机对照试验，纳入了在妊娠 83 天内寻求吸宫术的患者。参与者接受 TENS（放置在 T10-L1 和 S2-S4 处）或静脉（IV）镇静（芬太尼、咪达唑仑）。主要结局是通过视觉模拟量表（VAS，100mm）自我报告的抽吸时疼痛。为了以 90%的功效和 0.05 的显著性水平检测至少 15mm 的平均 VAS 差异，需要 90 名参与者。

结果

2018 年 1 月至 2019 年 10 月，我们共纳入 109 名参与者（TENS 组 55 名，IV 组 54 名）。TENS 组参与者的中位妊娠时间为 53 天（范围 36-82 天），IV 组为 58 天（范围 35-82 天）（P=.65）。组间人口统计学和临床病史相似。意向治疗分析（n=109）得出主要结局的非劣效结果（平均差异 4.8mm，95%CI-5.9 至 13.5mm）。在符合方案分析中，TENS 组有 9 名（16%）参与者在接受 IV 镇静后被排除；共纳入 100 名参与者（TENS 组 46 名，IV 组 54 名）。TENS 组和 IV 组报告的抽吸时 VAS 中位数（范围）分别为 73mm（13-97）和 66mm（0-99）（P=.40）。TENS 组的平均差异为 4.4mm（95%CI-5.6 至 14.5mm），我们发现 TENS 与 IV 一样非劣效。医生低估了参与者的疼痛，认为 TENS 组的疼痛为 34mm（6-91），IV 组为 25mm（0-83）（P=.003）。