NCT04399707|RecruitingFDA Device
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Sponsor study identifier
interventional
180
1 country
1
Study Start
January 29, 2020
Actual (reported)Primary Completion
May 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 29, 2020
Actual (reported)February 18, 2020
Actual (reported)May 22, 2020
Actual (reported)May 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Post-operative narcotic consumption
Total postoperative narcotic consumption (measured in morphine equivalents)
First 60 hours post-operatively
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
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
Adverse reactions to TENS unit
From date of randomization until date of discharge, assessed up to 1 month
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Nicole Kurata
Honolulu, Hawaii, 96826, United States
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.
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.
Kelly Yamasato
Physician
First Submitted
February 18, 2020
First Posted
May 22, 2020
Study Start
January 29, 2020
Actual (reported)Confirmatory Study of HFVI Guided Analgesic Administration in Surgical Subjects
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
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.
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.
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.
Primary Completion
May 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 26, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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