TENS Use for Post-cesarean Pain Management

NCT07777939 | Not Yet Recruiting

• 1 other identifier: HFH-323/2026
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post Cesarean Pain Management

Keywords

Cesarean delivery; TENS; POSTPARTUM PAIN

Outcome Measures

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.

  24 hours after cesarean delivery

Secondary Outcomes (15)

• Postoperative pain intensity at rest

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

• Postoperative pain intensity during movement

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

• Satisfaction with pain control

  24 and 48 hours after cesarean delivery

• Total opioid consumption

  Within 72 hours after cesarean delivery

• Time to first bowel function

  Within hospitalization (up to discharge, approximately 72 hours)

Study Arms (2)

TENS Group

EXPERIMENTAL

Patient will receive TENS within 2 hours after surgery in addition to the standard analgesic protocol.

Device: TENS

No-TENS Control Group

NO INTERVENTION

Patients will receive the standard analgesic protocol only.

Interventions

TENS DEVICE

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.

TENS Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Holy Family Hospital, Nazareth, Israel: lead

Study Sites (1)

Holy Family Hospital

Nazareth, Israel

Location

Related Publications (18)

• 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.

  PMID: 29397134 BACKGROUND

• 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.

  PMID: 26787793 BACKGROUND

• 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.

  PMID: 36378307 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32871021 BACKGROUND

• 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.

  PMID: 24953072 BACKGROUND

• 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.

  PMID: 23794648 BACKGROUND

• 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.

  PMID: 12600800 BACKGROUND

• 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.

  PMID: 20520646 BACKGROUND

• 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.

  PMID: 14622708 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 28625307 BACKGROUND

• 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.

  PMID: 34412076 BACKGROUND

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

  PMID: 29781876 BACKGROUND

• 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.

  PMID: 27756207 BACKGROUND

• Ciechanowicz S, Joy RR, Kasmirski J, Blake L, Carvalho B, Sultan P. Incidence, Severity, and Interference of Chronic Postsurgical Pain After Cesarean Delivery: A Systematic Review and Meta-analysis. J Clin Anesth. 2025 Jun;104:111832. doi: 10.1016/j.jclinane.2025.111832. Epub 2025 Apr 24.

  PMID: 40279839 BACKGROUND

• Shtainmetz N, Tesler R, Ash N, Korn L. Implementation of the Robson classification for caesarean sections in Israel: a 10-year cross-sectional study. Isr J Health Policy Res. 2025 Nov 4;14(1):63. doi: 10.1186/s13584-025-00726-z.

  PMID: 41184971 BACKGROUND

• Demilew BC, Zurbachew N, Getachew N, Mekete G, Lema DT. Prevalence and Associated Factors of Postoperative Acute Pain for Mothers Who Gave Birth With Cesarean Section: A Systematic Review and Meta-Analysis. Pain Manag Nurs. 2024 Dec;25(6):e452-e464. doi: 10.1016/j.pmn.2024.05.010. Epub 2024 Jul 20.

  PMID: 39033057 BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Raed Salim

  The Azrieli Faculty of Medicine, Bar Ilan University

  STUDY CHAIR

Central Study Contacts

Maysa Abboud, MD

CONTACT

972-509516904; abboudmaysa@gmail.com

Raed Salim, MD

CONTACT

0544986960; r.salim@hfhosp.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 20, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.

Locations

IL (1)