Authors
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Holy Family Hospital, Nazareth, Israel -More
Category
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Primary study
Registry of Trials»ClinicalTrials.gov
Year
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2026
Cesarean delivery is one of the most commonly performed surgical procedures worldwide andis frequently associated with moderate to severe acute postoperative pain. Adequate paincontrol is particularly important following cesarean delivery because women must recoverfrom major abdominal surgery while caring for and breastfeeding their newborns. Poorlycontrolled postoperative pain has been associated with delayed mobilization, impairedmaternal‐infant interaction, increased opioid consumption, chronic postsurgical pain, andpostpartum depression. Although multimodal pharmacological analgesia is the standardapproach for post‐cesarean pain management, opioid analgesics may cause adverse maternaleffects, including nausea, vomiting, sedation, and constipation, and there is increasinginterest in adjunctive non‐pharmacological interventions that may improve recovery whilereducing opioid requirements.Transcutaneous Electrical Nerve Stimulation (TENS) is a non‐invasive, safe, andinexpensive modality that delivers low‐voltage electrical stimulation through surfaceelectrodes to reduce pain. Proposed mechanisms include modulation of nociceptivetransmission through the gate control mechanism and stimulation of endogenous opioidrelease. Although previous systematic reviews suggest that TENS may reduce postoperativepain after cesarean delivery, the available evidence is limited by small sample sizes,methodological heterogeneity, and low certainty. Additional well‐designed randomizedcontrolled trials are needed to establish its clinical effectiveness.This study is a single‐center, randomized controlled trial designed to evaluate theeffectiveness of continuous 24‐hour TENS as an adjunct to standard postoperativeanalgesia in women undergoing cesarean delivery under spinal anesthesia. Eligibleparticipants will be randomized in a 1:1 ratio to receive either continuous TENS therapyin addition to standard postoperative care or standard postoperative care alone.TENS treatment will be initiated within 2 hours following cesarean delivery and appliedaround the surgical incision using standardized electrode placement and stimulationparameters. TENS will be administered for up to 24 hours. The TENS program is designed todeliver continuous stimulation for one hour. Participants will be encouraged to restartthe program every hour for up to 24 hours. They may temporarily discontinue stimulationin the event of discomfort, skin irritation, mobilization, hygiene needs, or at theirrequest.All participants will receive the same perioperative management, including standardizedspinal anesthesia, local wound infiltration, postoperative analgesic regimen, andpostoperative care according to departmental protocols. The primary outcome will be theQuality 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 72postoperative hours, time to bowel function recovery, maternal postoperativecomplications, breastfeeding outcomes, length of hospital stay, and adverse eventsrelated to TENS.The study will enroll 196 participants, with sample size determined to detect aclinically meaningful difference in QoR‐15 scores between groups. Analyses will beconducted according to the intention‐to‐treat principle. The findings of this trial willprovide high‐quality evidence regarding the effectiveness of continuous 24‐hour TENS asan adjunctive strategy for improving postoperative recovery and pain management followingcesarean delivery.
Epistemonikos ID: 22e0f0222b4d9ce300f93c1e9569cc0155e94439
First added on: Aug 20, 2026