TENS Use for Post-cesarean Pain Management
ConditionPost Cesarean Pain Management
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHoly Family Hospital, Nazareth, Israel
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women aged 18-45 years.
Undergoing CD under spinal anesthesia.
Hemodynamically stable postoperatively.
Able to provide informed consent.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TENS
DeviceParticipants randomized to the intervention group will receive continuous transcutaneous electrical nerve stimulation (TENS) in addition to standard postoperative analgesia. TENS will be initiated within 2 hours after cesarean delivery and applied continuously for the first 24 postoperative hours. Participants will be instructed to wear the device continuously and may temporarily remove the device for showering. All participants will receive in addition the institution's standard postoperative care and analgesic regimen following cesarean delivery.
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: TENS GroupExperimental treatment 1 intervention
Group B: No-TENS Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 deliverySecondary outcomes
1
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 delivery2
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 delivery3
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 delivery4
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 deliverySponsors and contacts
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Source ClinicalTrials.gov
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