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非侵入性生物电子治疗剖宫产术后疼痛:一项随机临床试验。

Noninvasive Bioelectronic Treatment of Postcesarean Pain: A Randomized Clinical Trial.

机构信息

Division of Maternal-Fetal Medicine, The Ohio State University Wexner Medical Center, Columbus, Ohio.

出版信息

JAMA Netw Open. 2023 Oct 2;6(10):e2338188. doi: 10.1001/jamanetworkopen.2023.38188.


DOI:10.1001/jamanetworkopen.2023.38188
PMID:37862016
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10589807/
Abstract

IMPORTANCE: Improved strategies are needed to decrease opioid use after cesarean delivery but still adequately control postoperative pain. Although transcutaneous electrical stimulation devices have proven effective for pain control after other surgical procedures, they have not been tested as part of a multimodal analgesic protocol after cesarean delivery, the most common surgical procedure in the United States. OBJECTIVE: To determine whether treatment with a noninvasive high-frequency electrical stimulation device decreases opioid use and pain after cesarean delivery. DESIGN, SETTING, AND PARTICIPANTS: This triple-blind, sham-controlled randomized clinical trial was conducted from April 18, 2022, to January 31, 2023, in the labor and delivery unit at a single tertiary academic medical center in Ohio. Individuals were eligible for the study if they had a singleton or twin gestation and underwent a cesarean delivery. Of 267 people eligible for the study, 134 (50%) were included. INTERVENTION: Participants were randomly assigned in a 1:1 ratio to a high-frequency (20 000 Hz) electrical stimulation device group or to an identical-appearing sham device group and received 3 applications at the incision site in the first 20 to 30 hours postoperatively. MAIN OUTCOMES AND MEASURES: The primary outcome was inpatient postoperative opioid use, measured in morphine milligram equivalents (MME). Secondary outcomes included pain scores, measured with the Brief Pain Inventory questionnaire (scale, 0-10, with 0 representing no pain), MME prescribed at discharge, and receipt of additional opioid prescriptions in the postpartum period. Normally distributed data were assessed using t tests; otherwise via Mann-Whitney or χ2 tests as appropriate. Analyses were completed following intention-to-treat principles. RESULTS: Of 134 postpartum individuals who underwent a cesarean delivery (mean [SD] age, 30.5 [4.6] years; mean [SD] gestational age at delivery, 38 weeks 6 days [8 days]), 67 were randomly assigned to the functional device group and 67 to the sham device group. Most were multiparous, had prepregnancy body mass index (calculated as weight in kilograms divided by height in meters squared) higher than 30, were privately insured, and received spinal anesthesia. One participant in the sham device group withdrew consent prior to treatment. Individuals assigned to the functional device used significantly less opioid medication prior to discharge (median [IQR], 19.75 [0-52.50] MME) than patients in the sham device group (median [IQR], 37.50 [7.50-67.50] MME; P = .046) and reported similar rates of moderate to severe pain (85% vs 91%; relative risk [RR], 0.77 [95% CI, 0.55-1.29]; P = .43) and mean pain scores (3.59 [95% CI, 3.21-3.98] vs 4.46 [95% CI, 4.01-4.92]; P = .004). Participants in the functional device group were prescribed fewer MME at discharge (median [IQR], 82.50 [0-90.00] MME vs 90.00 [75.00-90.00] MME; P < .001). They were also more likely to be discharged without an opioid prescription (25% vs 10%; RR, 1.58 [95% CI, 1.08-2.13]; P = .03) compared with the sham device group. No treatment-related adverse events occurred in either group. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of postoperative patients following cesarean delivery, use of a high-frequency electrical stimulation device as part of a multimodal analgesia protocol decreased opioid use in the immediate postoperative period and opioids prescribed at discharge. These findings suggest that the use of this device may be a helpful adjunct to decrease opioid use without compromising pain control after cesarean delivery.

摘要

重要性:需要改进策略来减少剖宫产术后阿片类药物的使用,但仍要充分控制术后疼痛。虽然经皮电刺激设备已被证明可有效控制其他手术后的疼痛,但它们尚未作为剖宫产术后多模式镇痛方案的一部分进行测试,而剖宫产是美国最常见的手术。 目的:确定非侵入性高频电刺激设备是否可以减少剖宫产术后的阿片类药物使用和疼痛。 设计、地点和参与者:这是一项三盲、假对照随机临床试验,于 2022 年 4 月 18 日至 2023 年 1 月 31 日在俄亥俄州一家三级学术医疗中心的产房进行。符合研究条件的个体为单胎或双胎妊娠,并接受剖宫产。267 名符合研究条件的人中,有 134 名(50%)被纳入。 干预措施:参与者被随机分配以 1:1 的比例接受高频(20000 Hz)电刺激设备组或相同外观的假设备组,并在术后 20 至 30 小时内接受 3 次切口部位应用。 主要结果和测量:主要结果是住院期间术后阿片类药物使用,以吗啡毫克当量(MME)衡量。次要结果包括疼痛评分,使用简短疼痛问卷(量表,0-10,0 代表无痛),出院时开的 MME 以及产后接受额外阿片类药物处方的情况。正态分布数据采用 t 检验;否则采用 Mann-Whitney 或 χ2 检验。分析遵循意向治疗原则。 结果:在 134 名接受剖宫产的产后个体中(平均[SD]年龄,30.5[4.6]岁;平均[SD]分娩时的孕周,38 周 6 天[8 天]),67 人被随机分配到功能设备组,67 人分配到假设备组。大多数为多产妇,孕前体重指数(体重以千克为单位,身高以米为单位计算)高于 30,私人保险,接受脊髓麻醉。假设备组中有 1 名参与者在治疗前撤回了同意。与假设备组相比,接受功能设备治疗的患者在出院前使用的阿片类药物明显减少(中位数[IQR],19.75[0-52.50] MME)(中位数[IQR],37.50[7.50-67.50] MME;P=0.046),报告的中度至重度疼痛发生率相似(85% vs 91%;相对风险[RR],0.77[95%CI,0.55-1.29];P=0.43)和平均疼痛评分(3.59[95%CI,3.21-3.98] vs 4.46[95%CI,4.01-4.92];P=0.004)。功能设备组的患者出院时开的 MME 较少(中位数[IQR],82.50[0-90.00] MME 与 90.00[75.00-90.00] MME;P<0.001)。与假设备组相比,他们也更有可能在没有开阿片类药物处方的情况下出院(25% vs 10%;RR,1.58[95%CI,1.08-2.13];P=0.03)。两组均未发生与治疗相关的不良事件。 结论和相关性:在这项关于剖宫产术后患者的随机临床试验中,高频电刺激设备作为多模式镇痛方案的一部分使用,减少了术后即刻和出院时开的阿片类药物的使用。这些发现表明,使用该设备可能有助于减少剖宫产术后阿片类药物的使用,而不会影响疼痛控制。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c18/10589807/7d8702610553/jamanetwopen-e2338188-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c18/10589807/aea493147e03/jamanetwopen-e2338188-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c18/10589807/7d8702610553/jamanetwopen-e2338188-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c18/10589807/aea493147e03/jamanetwopen-e2338188-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2c18/10589807/7d8702610553/jamanetwopen-e2338188-g002.jpg

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本文引用的文献

[1]
Interventions to Reduce Inpatient and Discharge Opioid Prescribing for Postpartum Patients: A Systematic Review.

J Midwifery Womens Health. 2023-3

[2]
High-frequency electrical stimulation attenuates neuronal release of inflammatory mediators and ameliorates neuropathic pain.

Bioelectron Med. 2022-10-5

[3]
Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Birth Pain Control: A Randomized Controlled Trial.

Obstet Gynecol. 2022-8-1

[4]
Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study.

Anesthesiology. 2021-7-1

[5]
Society for Obstetric Anesthesia and Perinatology: Consensus Statement and Recommendations for Enhanced Recovery After Cesarean.

Anesth Analg. 2021-5-1

[6]
Complementary and alternative therapies for post-caesarean pain.

Cochrane Database Syst Rev. 2020-9-1

[7]
Nonopioid versus opioid analgesia after hospital discharge following cesarean delivery: a randomized equivalence trial.

Am J Obstet Gynecol. 2019-12-6

[8]
Effects of transcutaneous electrical nerve stimulation (TENS) on acute postoperative pain intensity and mobility after hip fracture: A double-blinded, randomized trial.

Clin Interv Aging. 2019-10-29

[9]
The economic burden of the opioid epidemic on states: the case of Medicaid.

Am J Manag Care. 2019-7

[10]
Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women.

JAMA Netw Open. 2019-7-3

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