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Post Cesarean Pain ManagementNCT07777939

TENS Use for Post-cesarean Pain Management

A study testing TENS in people with Post Cesarean Pain Management, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Post Cesarean Pain Management
What is being tested?
TENS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
196 participants
Where
1 siteIsrael
Study dates
Sep 2026to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 10Show fewer
  • Adhesive allergy.
  • Midline vertical skin incision (in the current or previous cesarean).
  • Intraoperative sterilization.
  • Cesarean hysterectomy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Maysa Abboud, MD contact

972-509516904

abboudmaysa@gmail.com

Raed Salim, MD contact

0544986960

r.salim@hfhosp.org

Israel1 site
  • Holy Family Hospital

    Nazareth

    Raed, r.salim@hfhosp.org

Other trials in Israel

About this study

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

Read the detailed description

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.

Being tested
TENS
Keywords
Cesarean delivery, TENS, POSTPARTUM PAIN

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TENSDevice

    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.

Study groups in NCT07777939
Study groupRoleWhat they receive
TENS GroupExperimentalPatient will receive TENS within 2 hours after surgery in addition to the standard analgesic protocol.
Receives: Device: TENS
No-TENS Control GroupNo interventionPatients will receive the standard analgesic protocol only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours after cesarean delivery

Secondary outcomes (15)
  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.

    Measured: 2-4, 8-10, 24, and 48 hours after cesarean delivery

  2. 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.

    Measured: 2-4, 8-10, 24, and 48 hours after cesarean delivery

  3. 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).

    Measured: 24 and 48 hours after cesarean delivery

  4. Total opioid consumption

    Total rescue opioid use during the postoperative period, recorded as the number of tablets and total milligram dose.

    Measured: Within 72 hours after cesarean delivery

  5. Time to first bowel function

    Time from surgery to first passage of flatus or bowel movement.

    Measured: Within hospitalization (up to discharge, approximately 72 hours)

  6. Postpartum fever

    Occurrence of postpartum fever according to institutional diagnostic criteria.

    Measured: During hospitalization (up to approximately 72 hours after surgery)

  7. Endometritis

    Occurrence of clinically diagnosed postpartum endometritis.

    Measured: Perioperatively

  8. Surgical site infection

    Occurrence of surgical site infection diagnosed according to institutional criteria.

    Measured: Perioperatively

  9. Change in hemoglobin concentration

    Maximum difference between preoperative and postoperative hemoglobin levels

    Measured: Within 24 hours after cesarean delivery

  10. Heart rate

    Maximum and minimum daily heart rate recorded during routine postoperative monitoring

    Measured: Within the first 24 hours after cesarean delivery

  11. Respiratory rate

    Maximum and minimum daily respiratory rate recorded during routine postoperative monitoring

    Measured: Within the first 24 hours after cesarean delivery

  12. Time to first breastfeeding

    Time from cesarean delivery to the first breastfeeding session.

    Measured: Perioperatively

  13. Neonatal feeding method at discharge

    Infant feeding method at hospital discharge (exclusive breastfeeding, mixed feeding, or formula feeding).

    Measured: Up to one weeks

  14. Length of hospital stay

    Duration of hospitalization from cesarean delivery until discharge.

    Measured: through study completion, an average of 4 days.

  15. TENS-related adverse events

    Occurrence of adverse events related to TENS use, including skin irritation, pain, burning sensation, or other device-related reactions.

    Measured: During the 24-hour TENS intervention period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionAug 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
196 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07777939
Sponsor's protocol ID
HFH-323/2026
Status last verified
Sep 2026
First submitted
15 Aug 2026
Last updated
28 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual patient data (IPD) that underlie results in a publication

Publications

  • Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.

    PubMed 29397134
  • Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

    PubMed 26787793
  • Garmi G, Parasol M, Zafran N, Rudin M, Romano S, Salim R. Efficacy of Single Wound Infiltration With Bupivacaine and Adrenaline During Cesarean Delivery for Reduction of Postoperative Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242203. doi: 10.1001/jamanetworkopen.2022.42203.

    PubMed 36378307
  • Albadrani MS, Elhusein AM, Ali Fadlalmola H et al. The Clinical Effectiveness of Transcutaneous Electrical Nerve Stimulation on Enhancing Recovery after Cesarean Section: A Systematic Review and Meta-Analysis. Current Women s Health Reviews. 2024;20(5):53-64. https://doi.org/10.2174/1573404820666230731100639.

  • Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.

    PubMed 32871021
  • Vance CG, Dailey DL, Rakel BA, Sluka KA. Using TENS for pain control: the state of the evidence. Pain Manag. 2014 May;4(3):197-209. doi: 10.2217/pmt.14.13.

    PubMed 24953072
  • Smith BH, Lee J, Price C, Baranowski AP. Neuropathic pain: a pathway for care developed by the British Pain Society. Br J Anaesth. 2013 Jul;111(1):73-9. doi: 10.1093/bja/aet206.

    PubMed 23794648
  • Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.

    PubMed 12600800
  • Johnson MI, Walsh DM. Pain: continued uncertainty of TENS' effectiveness for pain relief. Nat Rev Rheumatol. 2010 Jun;6(6):314-6. doi: 10.1038/nrrheum.2010.77. No abstract available.

    PubMed 20520646
  • Sluka KA, Walsh D. Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain. 2003 Apr;4(3):109-21. doi: 10.1054/jpai.2003.434.

    PubMed 14622708
  • Halawani RK El, Elmokadem EM, Ismael KS et al. Adjuvant therapies for postoperative pain management in cesarean section: A comprehensive review of clinical evidence. Futur J Pharm Sci. 2026;12(1):45. https://doi.org/10.1186/s43094-026-00956-1.

  • Carvalho B, Butwick AJ. Postcesarean delivery analgesia. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):69-79. doi: 10.1016/j.bpa.2017.01.003. Epub 2017 Jan 12.

    PubMed 28625307
  • Pharmacologic Stepwise Multimodal Approach for Postpartum Pain Management: ACOG Clinical Consensus No. 1. Obstet Gynecol. 2021 Sep 1;138(3):507-517. doi: 10.1097/AOG.0000000000004517.

    PubMed 34412076
  • ACOG Committee Opinion No. 742: Postpartum Pain Management. Obstet Gynecol. 2018 Jul;132(1):e35-e43. doi: 10.1097/AOG.0000000000002683.

    PubMed 29781876
  • Jin J, Peng L, Chen Q, Zhang D, Ren L, Qin P, Min S. Prevalence and risk factors for chronic pain following cesarean section: a prospective study. BMC Anesthesiol. 2016 Oct 18;16(1):99. doi: 10.1186/s12871-016-0270-6.

    PubMed 27756207

Questions about this trial

What is this clinical trial studying?

A study testing TENS in people with Post Cesarean Pain Management, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Maysa Abboud, MD (972-509516904, abboudmaysa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery-15 (QoR-15) total score (time frame: 24 hours after cesarean delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07777939, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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