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Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

H

Hawaii Pacific Health

Status

Enrolling

Conditions

Cesarean Section
Analgesia
Transcutaneous Electric Nerve Stimulation

Treatments

Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit
Device: Transcutaneous electrical nerve stimulation (TENS) unit

Study type

Interventional

Funder types

Other

Identifiers

NCT04399707
2019-035

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

180 participants in 3 patient groups, including a placebo group

Active TENS Unit
Active Comparator group
Treatment:
Device: Transcutaneous electrical nerve stimulation (TENS) unit
Placebo TENS Unit
Placebo Comparator group
Treatment:
Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit
No TENS Unit
No Intervention group

Trial contacts and locations

1

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Central trial contact

Kelly Yamasato; Nicole Kurata

Data sourced from clinicaltrials.gov

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