NCT04399707 · Hawaii Pacific Health
Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
What this study is about
Purpose of study is to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) for post-operative pain control after a cesarean delivery compared to placebo and no TENS.
View original scientific description
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
DEVICE
Transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
DEVICE
Placebo transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Primary outcome measures
Post-operative narcotic consumption
Time frame: First 60 hours post-operatively
Total postoperative narcotic consumption (measured in morphine equivalents)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Honolulu, Hawaii
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 26, 2020 · Source of record for eligibility and locations