Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
Purpose
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.
Conditions
- Transcutaneous Electric Nerve Stimulation
- Analgesia
- Cesarean Section
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants are randomized to one of three groups in parallel for the duration of the study
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Active TENS Unit |
|
|
|
Placebo Comparator Placebo TENS Unit |
|
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|
No Intervention No TENS Unit |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Hawaii Pacific Health