Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Not Applicable

Recruiting

• Conditions: Transcutaneous Electric Nerve Stimulation; Cesarean Section; Analgesia
• Interventions: Device: Placebo transcutaneous electrical nerve stimulation (TENS) unit; Device: Transcutaneous electrical nerve stimulation (TENS) unit

• Registration Number: NCT04399707
• Lead Sponsor: Hawaii Pacific Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-29
• Study First Submitted: 2020-02-18
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-19
• Last Update Submitted: 2020-05-21
• Study First Posted: 2020-05-22
• Last Update Posted: 2020-05-26
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo TENS Unit	Placebo transcutaneous electrical nerve stimulation (TENS) unit	-
Active TENS Unit	Transcutaneous electrical nerve stimulation (TENS) unit	-

Primary Outcome Measures

Name	Time	Method
Post-operative narcotic consumption	First 60 hours post-operatively	Total postoperative narcotic consumption (measured in morphine equivalents)

Secondary Outcome Measures

Name	Time	Method
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
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
Adverse reactions to TENS unit	From date of randomization until date of discharge, assessed up to 1 month	Adverse reactions to TENS unit

Trial Locations

Locations (1)

Nicole Kurata; 🇺🇸 Honolulu, Hawaii, United States