Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

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

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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