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RecruitingNot ApplicableNCT04399707

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Sponsor

Hawaii Pacific Health

Enrollment

180 participants

Start Date

Jan 29, 2020

Study Type

INTERVENTIONAL

Conditions

AnalgesiaTranscutaneous Electric Nerve StimulationCesarean Section

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria1

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

Exclusion Criteria12

  • 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

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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

Locations(1)

Nicole Kurata

Honolulu, Hawaii, United States

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NCT04399707

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