Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHawaii Pacific Health
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous electrical nerve stimulation (TENS) unit
DevicePatients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Placebo transcutaneous electrical nerve stimulation (TENS) unit
DevicePatients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Treatment groups
180 Participants
are divided into 3 treatment groupsGroup A: Active TENS UnitActive comparator 1 intervention
Group B: Placebo TENS UnitPlacebo comparator 1 intervention
Group C: No TENS UnitNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Post-operative narcotic consumption
Total postoperative narcotic consumption (measured in morphine equivalents)
Time frame
First 60 hours post-operativelySecondary outcomes
1
Duration of hospitalization
Length of stay in hospital
Time frame
From date of cesarean delivery until discharge from hospital, assessed up to 1 month2
Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)
Pain scoring
Time frame
On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month3
Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)
Pain control satisfaction
Time frame
On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month4
Adverse reactions to TENS unit
Adverse reactions to TENS unit
Time frame
From date of randomization until date of discharge, assessed up to 1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov