Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 2021

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

Arms, Groups and Cohorts

  • Active Comparator: Active TENS Unit
  • Placebo Comparator: Placebo TENS Unit
  • No Intervention: No TENS Unit

Clinical Trial Outcome Measures

Primary Measures

  • Post-operative narcotic consumption
    • Time Frame: First 60 hours post-operatively
    • Total postoperative narcotic consumption (measured in morphine equivalents)

Secondary Measures

  • Duration of hospitalization
    • Time Frame: 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)
    • Time Frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
    • Pain scoring
  • Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)
    • Time Frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
    • Pain control satisfaction
  • Adverse reactions to TENS unit
    • Time Frame: From date of randomization until date of discharge, assessed up to 1 month
    • Adverse reactions to TENS unit

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Hawaii Pacific Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kelly Yamasato, MD, Physician, Assistant Professor – Hawaii Pacific Health
  • Overall Official(s)
    • Kelly Yamasato, Principal Investigator, Physician
  • Overall Contact(s)
    • Nicole Kurata, (808)577-3344, nkurata@hawaii.edu

References

Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naïve women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.

Desantana JM, Sluka KA, Lauretti GR. High and low frequency TENS reduce postoperative pain intensity after laparoscopic tubal ligation: a randomized controlled trial. Clin J Pain. 2009 Jan;25(1):12-9. doi: 10.1097/AJP.0b013e31817d1070.

Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8.

Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008. Erratum in: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text.

Dowswell T, Bedwell C, Lavender T, Neilson JP. Transcutaneous electrical nerve stimulation (TENS) for pain relief in labour. Cochrane Database Syst Rev. 2009 Apr 15;(2):CD007214. doi: 10.1002/14651858.CD007214.pub2. Review.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.