Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
NCT ID: NCT04399707
Last Updated: 2020-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2020-01-29
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active TENS Unit
Transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Placebo TENS Unit
Placebo transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
No TENS Unit
No interventions assigned to this group
Interventions
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Transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Placebo transcutaneous electrical nerve stimulation (TENS) unit
Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Hawaii Pacific Health
OTHER
Responsible Party
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Kelly Yamasato, MD
Physician, Assistant Professor
Principal Investigators
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Kelly Yamasato
Role: PRINCIPAL_INVESTIGATOR
Physician
Locations
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Nicole Kurata
Honolulu, Hawaii, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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2019-035
Identifier Type: -
Identifier Source: org_study_id
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