Analgesia, Cesarean Section, Transcutaneous Electric Nerve Stimulation
Conditions
Keywords
TENS, Transcutaneous electric nerve stimulation, Cesarean analgesia
Brief 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.
Interventions
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
Sponsors
Hawaii Pacific Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Participants are randomized to one of three groups in parallel for the duration of the study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative narcotic consumption | First 60 hours post-operatively | Total postoperative narcotic consumption (measured in morphine equivalents) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | From date of cesarean delivery until discharge from hospital, assessed up to 1 month | Length of stay in hospital |
| Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain) | On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month | Pain scoring |
| Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied) | On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month | Pain control satisfaction |
| Adverse reactions to TENS unit | From date of randomization until date of discharge, assessed up to 1 month | Adverse reactions to TENS unit |
Countries
United States
Contacts
Primary ContactNicole Kurata
Backup ContactKelly Yamasato
Outcome results
None listed