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RecruitingNCT04399707Updated May 26, 2020

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

An interventional study of Transcutaneous electrical nerve stimulation (TENS) unit and Placebo transcutaneous electrical nerve stimulation (TENS) unit in Transcutaneous Electric Nerve Stimulation, Analgesia and Cesarean Section, sponsored by Hawaii Pacific Health. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-26.

Sponsored by Hawaii Pacific Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2021, 5 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jan 2020; still recruiting 6 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Purpose of study is to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.

02

Conditions studied

  • Transcutaneous Electric Nerve Stimulation
  • Analgesia
  • Cesarean Section

Keywords

  • TENS
  • Transcutaneous electric nerve stimulation
  • Cesarean analgesia
03

In context

Lead sponsor

Hawaii Pacific Health is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women undergoing scheduled or non-urgent cesarean section

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking
  • Subjects with a history of chronic pain or chronic opioid use
  • Pre-operative use of opioids for more than 1 week in the preceding 6 months
  • Previous exposure to the TENS unit
  • Women with an allergy or contraindication to narcotics/NSAIDs/acetaminophen
  • Subjects who had a midline vertical skin incision during this operation
  • Subjects who did not receive intrathecal opioids at the time of their cesarean delivery
  • Adhesive allergies
  • Subjects with a pacemaker (due to the unknown effects of the TENS on the electrical activity of the heart)
  • Intraoperative general anesthesia
  • Inability to consent to the study
  • Postpartum tubal ligation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
180 participants (estimated)

Study arms

  • Active comparator
    Active TENS Unit

    Device: Transcutaneous electrical nerve stimulation (TENS) unit

  • Placebo comparator
    Placebo TENS Unit

    Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit

  • No intervention
    No TENS Unit

Interventions

  • DeviceTranscutaneous electrical nerve stimulation (TENS) unit

    Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit

  • DevicePlacebo transcutaneous electrical nerve stimulation (TENS) unit

    Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit

06

What researchers measure

Primary outcomes

  1. Post-operative narcotic consumption

    Total postoperative narcotic consumption (measured in morphine equivalents)

    Time frame: First 60 hours post-operatively

Secondary outcomes

  1. Duration of hospitalization

    Length of stay in hospital

    Time frame: From date of cesarean delivery until discharge from hospital, assessed up to 1 month

  2. Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)

    Pain scoring

    Time frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month

  3. Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)

    Pain control satisfaction

    Time frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month

  4. Adverse reactions to TENS unit

    Adverse reactions to TENS unit

    Time frame: From date of randomization until date of discharge, assessed up to 1 month

07

Study locations

1 of 1 sites recruiting
  • Nicole Kurata
    Honolulu, Hawaii 96826, United States
    • Nicole Kurata · Contact · nkurata@hawaii.edu · 808-577-3344
    • Kelly Yamasato, MD · Principal investigator
    • Nicole Kurata, MD · Sub investigator
    • Bliss Kaneshiro, MD · Sub investigator
    • Reema Ghatnekar, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17. PubMed 26996986 ↗
  • Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: a randomized controlled trial. Clin J Pain. 2009 Jan;25(1):12-9. doi: 10.1097/AJP.0b013e31817d1070. PubMed 19158541 ↗
  • 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 ↗
  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum In: J Pain. 2016 Apr;17(4):508-10. doi: 10.1016/j.jpain.2016.02.002.. Dosage error in article text. PubMed 26827847 ↗
  • Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2. PubMed 19370680 ↗
  • Kurata NB, Ghatnekar RJ, Mercer E, Chin JM, Kaneshiro B, Yamasato KS. Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Birth Pain Control: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):174-180. doi: 10.1097/AOG.0000000000004798. Epub 2022 Jul 6. PubMed 35852266 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04399707
Lead sponsor
Hawaii Pacific Health
Responsible party
Kelly Yamasato, MD (Physician, Assistant Professor, Hawaii Pacific Health) — Principal investigator
First posted
May 22, 2020
Start date
Jan 29, 2020
Primary completion
May 2021 (estimated)
Completion
May 2021 (estimated)
Last update
May 26, 2020

Study contacts

Nicole Kurata
Contact
nkurata@hawaii.edu
(808)577-3344
Kelly Yamasato
Contact
kyamasat@hawaii.edu
Kelly Yamasato
principal investigator · Physician

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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