An interventional study of TENS in Post Cesarean Pain Management, sponsored by Holy Family Hospital, Nazareth, Israel. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Holy Family Hospital, Nazareth, Israel · Not applicable, Interventional, and Treatment
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 196 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Holy Family Hospital, Nazareth, Israel is the lead sponsor of 10 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will receive TENS within 2 hours after surgery in addition to the standard analgesic protocol.
Device: TENS
Patients will receive the standard analgesic protocol only.
Participants randomized to the intervention group will receive TENS in addition to standard postoperative analgesia. TENS will be initiated within 2 hours after cesarean delivery and administered during the first 24 postoperative hours. Participants will be instructed to wear the device continuously during this period. Each TENS stimulation cycle will last 1 hour, using a frequency of 80 Hz, a pulse width of 200 µs, and an intensity of 20-40 mA. Participants will be encouraged to restart the stimulation program at the end of each hourly cycle for up to 24 hours. Stimulation may be temporarily discontinued in the event of discomfort or skin irritation, during mobilization or hygiene activities, or at the participant's request. All participants will additionally receive the institution's standard postoperative care and analgesic regimen following cesarean delivery.
Quality of Recovery-15 (QoR-15) total score
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.
Time frame: 24 hours after cesarean delivery
Postoperative pain intensity at rest
Pain intensity assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) while at rest.
Time frame: 2-4, 8-10, 24, and 48 hours after cesarean delivery
Postoperative pain intensity during movement
Pain intensity assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain) after 2-3 minutes of walking.
Time frame: 2-4, 8-10, 24, and 48 hours after cesarean delivery
Satisfaction with pain control
Patient satisfaction with postoperative pain management measured using an 11-point NRS ranging from 0 (not satisfied) to 10 (very satisfied).
Time frame: 24 and 48 hours after cesarean delivery
Total opioid consumption
Total rescue opioid use during the postoperative period, recorded as the number of tablets and total milligram dose.
Time frame: Within 72 hours after cesarean delivery
Time to first bowel function
Time from surgery to first passage of flatus or bowel movement.
Time frame: Within hospitalization (up to discharge, approximately 72 hours)
Postpartum fever
Occurrence of postpartum fever according to institutional diagnostic criteria.
Time frame: During hospitalization (up to approximately 72 hours after surgery)
Endometritis
Occurrence of clinically diagnosed postpartum endometritis.
Time frame: Perioperatively
Surgical site infection
Occurrence of surgical site infection diagnosed according to institutional criteria.
Time frame: Perioperatively
Change in hemoglobin concentration
Maximum difference between preoperative and postoperative hemoglobin levels
Time frame: Within 24 hours after cesarean delivery
Heart rate
Maximum and minimum daily heart rate recorded during routine postoperative monitoring
Time frame: Within the first 24 hours after cesarean delivery
Respiratory rate
Maximum and minimum daily respiratory rate recorded during routine postoperative monitoring
Time frame: Within the first 24 hours after cesarean delivery
Time to first breastfeeding
Time from cesarean delivery to the first breastfeeding session.
Time frame: Perioperatively
Neonatal feeding method at discharge
Infant feeding method at hospital discharge (exclusive breastfeeding, mixed feeding, or formula feeding).
Time frame: Up to one weeks
Length of hospital stay
Duration of hospitalization from cesarean delivery until discharge.
Time frame: through study completion, an average of 4 days.
TENS-related adverse events
Occurrence of adverse events related to TENS use, including skin irritation, pain, burning sensation, or other device-related reactions.
Time frame: During the 24-hour TENS intervention period
Plan to share: Yes — Individual patient data (IPD) that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: After publication (starting 6 months after publication).
Access criteria: De-identified IPD will be available to academic or clinical researchers for meta-analyses, and research addressing questions related to the study topic. Requests must include a research protocol, statistical analysis plan, ethics approval, and details of the research team. Requests will be reviewed by the principal investigator. Data will be provided after approval and completion of a data-sharing agreement.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Holy Family Hospital, Nazareth, Israel