Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Hawaii Pacific Health1 site in 1 country180 target enrollmentJanuary 29, 2020

ConditionsTranscutaneous Electric Nerve Stimulation Analgesia Cesarean Section

Overview

Phase: N/A
Intervention: Not specified
Conditions: Transcutaneous Electric Nerve Stimulation
Sponsor: Hawaii Pacific Health
Enrollment: 180
Locations: 1
Primary Endpoint: Post-operative narcotic consumption
Status: Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 29, 2020

End Date

May 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Hawaii Pacific Health

Responsible Party

Principal Investigator

Kelly Yamasato, MD

Physician, Assistant Professor

Hawaii Pacific Health

Eligibility Criteria

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

Outcomes

Primary Outcomes

Post-operative narcotic consumption

Time Frame: First 60 hours post-operatively

Total postoperative narcotic consumption (measured in morphine equivalents)

Secondary Outcomes

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)
Duration of hospitalization(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)(On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month)
Adverse reactions to TENS unit(From date of randomization until date of discharge, assessed up to 1 month)