Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

May 21, 2020 updated by: Kelly Yamasato, MD, Hawaii Pacific Health
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Nicole Kurata
        • Contact:
        • Principal Investigator:
          • Kelly Yamasato, MD
        • Sub-Investigator:
          • Nicole Kurata, MD
        • Sub-Investigator:
          • Bliss Kaneshiro, MD
        • Sub-Investigator:
          • Reema Ghatnekar, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative narcotic consumption
Time Frame: First 60 hours post-operatively
Total postoperative narcotic consumption (measured in morphine equivalents)
First 60 hours post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospitalization
Time Frame: From date of cesarean delivery until discharge from hospital, assessed up to 1 month
Length of stay in hospital
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)
Time Frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Pain scoring
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)
Time Frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Pain control satisfaction
On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
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
From date of randomization until date of discharge, assessed up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hawaii Pacific Health

Investigators

  • Principal Investigator: Kelly Yamasato, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2019-035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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