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Recruiting NCT04399707

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

No phase Interventional Transcutaneous Electric Nerve Stimulation Analgesia Cesarean Section

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous electrical nerve stimulation (TENS) unit, Placebo transcutaneous electrical nerve stimulation (TENS) unit.
Who it may be relevant to
Registry conditions: Transcutaneous Electric Nerve Stimulation, Analgesia, Cesarean Section. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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]
Secondary outcome measures (4)
  • Duration of hospitalization [Time frame: 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) [Time frame: 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) [Time frame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month]
  • Adverse reactions to TENS unit [Time frame: From date of randomization until date of discharge, assessed up to 1 month]

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
  • Inability to consent to the study
  • Postpartum tubal ligation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Nicole Kurata — Honolulu

Publications

  • 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-naive 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. PMID 26996986
  • 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. PMID 19158541
  • 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. doi: 10.1016/S1090-3801(02)00098-8. PMID 12600800
  • 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 America PMID 26827847
  • 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. PMID 19370680
  • Kurata NB, Ghatnekar RJ, Mercer E, Chin JM, Kaneshiro B, Yamasato KS. Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Birth Pain Control: A Randomized Controlled Trial. Obstet Gynecol. 2022 Aug 1;140(2):174-180. doi: 10.1097/AOG.0000000000004798. Epub 2022 Jul 6. PMID 35852266

Identifiers

NCT: NCT04399707 · 2019-035

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗