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NCT Number: NCT04399707

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

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.

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Key information

Conditions

Transcutaneous Electric Nerve Stimulation Agnosia Analgesia Cesarean Section Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Nicole Kurata

Honolulu, Hawaii, 96826, United States

Location status: Recruiting

Location contact

Bliss Kaneshiro, MD

SUB_INVESTIGATOR

Kelly Yamasato, MD

PRINCIPAL_INVESTIGATOR

Nicole Kurata

CONTACT

[email protected]

808-577-3344

Nicole Kurata, MD

SUB_INVESTIGATOR

Reema Ghatnekar, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS) unit

Device

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

Placebo transcutaneous electrical nerve stimulation (TENS) unit

Device

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

Primary outcomes

  1. Post-operative narcotic consumption

    Time frame: First 60 hours post-operatively

    Total postoperative narcotic consumption (measured in morphine equivalents)

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Kelly Yamasato

CONTACT

[email protected]

Nicole Kurata

CONTACT

[email protected]

(808)577-3344

Sponsors and collaborators

Lead sponsor

Hawaii Pacific Health

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 22, 2020
Registry last updated
May 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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