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临床试验/NCT07777939
NCT07777939尚未招募不适用

Continuous 24-Hour Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Management: A Randomized Controlled Trial

Holy Family Hospital, Nazareth, Israel1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
196
试验地点
1
主要终点
Quality of Recovery-15 (QoR-15) total score

研究概览

简要总结

The aim of this randomized controlled trial is to evaluate the effectiveness of continuous 24-hour Transcutaneous Electrical Nerve Stimulation (TENS) as an adjunct to standard postoperative care for pain management following cesarean delivery. Eligible women undergoing cesarean delivery under spinal anesthesia will be randomly assigned in a 1:1 ratio to either the intervention group, which will receive continuous TENS in addition to standard postoperative analgesia, or the control group, which will receive standard postoperative analgesia alone. The primary outcome is the Quality of Recovery-15 (QoR-15) score assessed 24 hours after cesarean delivery.

详细描述

Cesarean delivery is one of the most commonly performed surgical procedures worldwide and is frequently associated with moderate to severe acute postoperative pain. Adequate pain control is particularly important following cesarean delivery because women must recover from major abdominal surgery while caring for and breastfeeding their newborns. Poorly controlled postoperative pain has been associated with delayed mobilization, impaired maternal-infant interaction, increased opioid consumption, chronic postsurgical pain, and postpartum depression. Although multimodal pharmacological analgesia is the standard approach for post-cesarean pain management, opioid analgesics may cause adverse maternal effects, including nausea, vomiting, sedation, and constipation, and there is increasing interest in adjunctive non-pharmacological interventions that may improve recovery while reducing opioid requirements.

Transcutaneous Electrical Nerve Stimulation (TENS) is a non-invasive, safe, and inexpensive modality that delivers low-voltage electrical stimulation through surface electrodes to reduce pain. Proposed mechanisms include modulation of nociceptive transmission through the gate control mechanism and stimulation of endogenous opioid release. Although previous systematic reviews suggest that TENS may reduce postoperative pain after cesarean delivery, the available evidence is limited by small sample sizes, methodological heterogeneity, and low certainty. Additional well-designed randomized controlled trials are needed to establish its clinical effectiveness.

This study is a single-center, randomized controlled trial designed to evaluate the effectiveness of continuous 24-hour TENS as an adjunct to standard postoperative analgesia in women undergoing cesarean delivery under spinal anesthesia. Eligible participants will be randomized in a 1:1 ratio to receive either continuous TENS therapy in addition to standard postoperative care or standard postoperative care alone. TENS treatment will be initiated within two hours after surgery and applied around the surgical incision using standardized electrode placement and stimulation parameters. Participants assigned to the intervention group will be encouraged to use the device continuously during the first 24 postoperative hours, with stimulation intensity adjusted according to individual comfort.

All participants will receive the same perioperative management, including standardized spinal anesthesia, local wound infiltration, postoperative analgesic regimen, and postoperative care according to departmental protocols. The primary outcome will be the Quality of Recovery-15 (QoR-15) score assessed 24 hours after cesarean delivery. Secondary outcomes will include postoperative pain intensity at rest and during movement, patient satisfaction with pain management, opioid consumption during the first 72 postoperative hours, time to bowel function recovery, maternal postoperative complications, breastfeeding outcomes, length of hospital stay, and adverse events related to TENS.

The study will enroll 196 participants, with sample size determined to detect a clinically meaningful difference in QoR-15 scores between groups. Analyses will be conducted according to the intention-to-treat principle. The findings of this trial will provide high-quality evidence regarding the effectiveness of continuous 24-hour TENS as an adjunctive strategy for improving postoperative recovery and pain management following cesarean delivery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-45 years.
  • Undergoing CD under spinal anesthesia.
  • Hemodynamically stable postoperatively.
  • Able to provide informed consent.

排除标准

  • Undergoing CD under epidural or general anesthesia.
  • Skin lesions or infection at electrode placement sites.
  • Pacemaker or implanted electrical devices.
  • Neurological disorders affecting pain perception.
  • Chronic opioid use or chronic pain disorders.
  • Allergy or other contraindication to opioids, nonsteroidal antiinflammatory drugs, or acetaminophen use.
  • Adhesive allergy.
  • Midline vertical skin incision (in the current or previous cesarean).
  • Intraoperative sterilization.
  • Cesarean hysterectomy.

研究组 & 干预措施

TENS Group

Experimental

Patient will receive TENS within 2 hours after surgery in addition to the standard analgesic protocol.

干预措施: TENS (Device)

No-TENS Control Group

No Intervention

Patients will receive the standard analgesic protocol only.

结局指标

主要结局

Quality of Recovery-15 (QoR-15) total score

时间窗: 24 hours after cesarean delivery

The Quality of Recovery-15 (QoR-15) is a validated 15-item patient-reported questionnaire that assesses postoperative recovery across five domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is scored from 0 to 10, yielding a total score ranging from 0 to 150, with higher scores indicating better postoperative recovery.

次要结局

  • Postoperative pain intensity at rest(2-4, 8-10, 24, and 48 hours after cesarean delivery)
  • Endometritis(Perioperatively)
  • Satisfaction with pain control(24 and 48 hours after cesarean delivery)
  • Total opioid consumption(Within 72 hours after cesarean delivery)
  • Time to first bowel function(Within hospitalization (up to discharge, approximately 72 hours))
  • Postpartum fever(During hospitalization (up to approximately 72 hours after surgery))
  • Surgical site infection(Perioperatively)
  • Change in hemoglobin concentration(Within 24 hours after cesarean delivery)
  • Heart rate(Within the first 24 hours after cesarean delivery)
  • Respiratory rate(Within the first 24 hours after cesarean delivery)
  • Time to first breastfeeding(Perioperatively)
  • Neonatal feeding method at discharge(Up to one weeks)
  • Length of hospital stay(through study completion, an average of 4 days.)
  • TENS-related adverse events(During the 24-hour TENS intervention period)
  • Postoperative pain intensity during movement(2-4, 8-10, 24, and 48 hours after cesarean delivery)

研究者

发起方
Holy Family Hospital, Nazareth, Israel
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raed Salim, MD

Professor

Holy Family Hospital, Nazareth, Israel

研究点 (1)

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