Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Study Overview
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Brief Summary
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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.

Official Title
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Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Conditions
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Transcutaneous Electric Nerve Stimulation, Analgesia, Cesarean Section

Intervention / Treatment
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* Device: Transcutaneous electrical nerve stimulation (TENS) unit
* Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are randomized to one of three groups in parallel for the duration of the study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active TENS Unit<br> | Device: Transcutaneous electrical nerve stimulation (TENS) unit<br>* Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit<br>|
| Placebo Comparator: Placebo TENS Unit<br> | Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit<br>* Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit<br>|
| No Intervention: No TENS Unit<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative narcotic consumption | Total postoperative narcotic consumption (measured in morphine equivalents) | First 60 hours post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospitalization | Length of stay in hospital | From date of cesarean delivery until discharge from hospital, assessed up to 1 month | 
| Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain) | Pain scoring | On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month | 
| Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied) | Pain control satisfaction | On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month | 
| Adverse reactions to TENS unit | Adverse reactions to TENS unit | From date of randomization until date of discharge, assessed up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TENS, Transcutaneous electric nerve stimulation, Cesarean analgesia