Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Part of paid clinical trials in Honolulu, Hawaii.

Sponsor
Hawaii Pacific Health
Study ID
NCT04399707
Status
Recruiting

Conditions

  • Analgesia
  • Cesarean Section
  • Transcutaneous Electric Nerve Stimulation

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jan 29, 2020
Status verified
May 2020
Primary completion
May 31, 2021
Completion
May 31, 2021

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active TENS Unit
  • Placebo Comparator: Placebo TENS Unit
  • No Intervention: No TENS Unit

Primary Outcome Measure

Post-operative narcotic consumption [ Time Frame: First 60 hours post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nicole KurataHonoluluHawaii96826
Nicole Kurata
808-577-3344
Kelly Yamasato, MD (PRINCIPAL_INVESTIGATOR)
Nicole Kurata, MD (SUB_INVESTIGATOR)
Bliss Kaneshiro, MD (SUB_INVESTIGATOR)
Reema Ghatnekar, MD (SUB_INVESTIGATOR)

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