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
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)
View Full Details on ClinicalTrials.gov
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NCT04399707
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