NCT04399707

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 22, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

1.3 years

First QC Date

February 18, 2020

Last Update Submit

May 21, 2020

Conditions

Transcutaneous Electric Nerve StimulationAnalgesiaCesarean Section

Keywords

TENSTranscutaneous electric nerve stimulationCesarean analgesia

Outcome Measures

Primary Outcomes (1)

  • Post-operative narcotic consumption

    Total postoperative narcotic consumption (measured in morphine equivalents)

    First 60 hours post-operatively

Secondary Outcomes (4)

  • Duration of hospitalization

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

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

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

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

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

  • Adverse reactions to TENS unit

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

Study Arms (3)

Active TENS Unit

ACTIVE COMPARATOR
Device: Transcutaneous electrical nerve stimulation (TENS) unit

Placebo TENS Unit

PLACEBO COMPARATOR
Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit

No TENS Unit

NO INTERVENTION

Interventions

Transcutaneous electrical nerve stimulation (TENS) unitDEVICE

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

Active TENS Unit
Placebo transcutaneous electrical nerve stimulation (TENS) unitDEVICE

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

Placebo TENS Unit

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Women undergoing scheduled or non-urgent cesarean section

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nicole Kurata

Honolulu, Hawaii, 96826, United States

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26996986BACKGROUND

  • 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.

    PMID: 19158541BACKGROUND

  • 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: 12600800BACKGROUND

  • 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.

    PMID: 26827847BACKGROUND

  • 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.

    PMID: 19370680BACKGROUND

  • 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.

    PMID: 35852266DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Kelly Yamasato

    Physician

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Kurata

CONTACT

(808)577-3344nkurata@hawaii.edu

Kelly Yamasato

CONTACT

kyamasat@hawaii.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are randomized to one of three groups in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician, Assistant Professor

Study Record Dates

First Submitted

February 18, 2020

First Posted

May 22, 2020

Study Start

January 29, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

May 26, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)