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Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

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ClinicalTrials.gov Identifier: NCT04399707
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Kelly Yamasato, MD, Hawaii Pacific Health

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.

Condition or disease Intervention/treatment Phase
Transcutaneous Electric Nerve Stimulation Analgesia Cesarean Section Device: Transcutaneous electrical nerve stimulation (TENS) unit Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomized to one of three groups in parallel for the duration of the study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
Actual Study Start Date : January 29, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active TENS Unit Device: Transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit

Placebo Comparator: Placebo TENS Unit Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit

No Intervention: No TENS Unit



Primary Outcome Measures :
  1. Post-operative narcotic consumption [ Time Frame: First 60 hours post-operatively ]
    Total postoperative narcotic consumption (measured in morphine equivalents)


Secondary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: From date of cesarean delivery until discharge from hospital, assessed up to 1 month ]
    Length of stay in hospital

  2. Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain) [ Time Frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month ]
    Pain scoring

  3. Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied) [ Time Frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month ]
    Pain control satisfaction

  4. Adverse reactions to TENS unit [ Time Frame: From date of randomization until date of discharge, assessed up to 1 month ]
    Adverse reactions to TENS unit



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Women undergoing scheduled or non-urgent cesarean section

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399707


Contacts
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Contact: Nicole Kurata (808)577-3344 nkurata@hawaii.edu
Contact: Kelly Yamasato kyamasat@hawaii.edu

Locations
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United States, Hawaii
Nicole Kurata Recruiting
Honolulu, Hawaii, United States, 96826
Contact: Nicole Kurata    808-577-3344    nkurata@hawaii.edu   
Principal Investigator: Kelly Yamasato, MD         
Sub-Investigator: Nicole Kurata, MD         
Sub-Investigator: Bliss Kaneshiro, MD         
Sub-Investigator: Reema Ghatnekar, MD         
Sponsors and Collaborators
Hawaii Pacific Health
Investigators
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Principal Investigator: Kelly Yamasato Physician
Additional Information:
Publications:

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Responsible Party: Kelly Yamasato, MD, Physician, Assistant Professor, Hawaii Pacific Health
ClinicalTrials.gov Identifier: NCT04399707    
Other Study ID Numbers: 2019-035
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Kelly Yamasato, MD, Hawaii Pacific Health:
TENS
Transcutaneous electric nerve stimulation
Cesarean analgesia