Continuous 24-Hour Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Management: A Randomized Controlled Trial
| Registry | NCT07777939 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 196 (Estimated) |
| Sponsor | Holy Family Hospital, Nazareth, Israel (Other) |
| Conditions | Post Cesarean Pain Management |
| Interventions | TENS (Device) |
| Dates | start 2026-09-01 (estimated), primary completion 2027-08-01 (estimated), completion 2027-09-01 (estimated), first posted 2026-08-20, last updated 2026-09-28 |
| Locations | 1 site in Israel |
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All trials for Post Cesarean Pain Management All trials of TENS
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.
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 2 hours following cesarean delivery and applied around the surgical incision using standardized electrode placement and stimulation parameters. TENS will be administered for up to 24 hours. The TENS program is designed to deliver continuous stimulation for one hour. Participants will be encouraged to restart the program every hour for up to 24 hours. They may temporarily discontinue stimulation in the event of discomfort, skin irritation, mobilization, hygiene needs, or at their request.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TENS Group | Experimental | Device: TENS | Patient will receive TENS within 2 hours after surgery in addition to the standard analgesic protocol. |
| No-TENS Control Group | No intervention | Patients will receive the standard analgesic protocol only. |
Sex: Female, ages: 18 Years to 45 Years
Inclusion Criteria: * Women aged 18-45 years. * Undergoing CD under spinal anesthesia. * Hemodynamically stable postoperatively. * Able to provide informed consent. Exclusion Criteria: * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| Holy Family Hospital | Nazareth | Israel |