Clinical trial NCT04399707: Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
Official title: Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcutaneous Electric Nerve Stimulation
Analgesia
Cesarean Section
Keywords: TENS
Transcutaneous electric nerve stimulation
Cesarean analgesia
Lead sponsor: Hawaii Pacific Health
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to one of three groups in parallel for the duration of the study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Post-operative narcotic consumption
timeFrame: First 60 hours post-operatively
Secondary outcomes:
measure: Duration of hospitalization
timeFrame: From date of cesarean delivery until discharge from hospital, assessed up to 1 month
measure: Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)
timeFrame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
measure: Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)
timeFrame: On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
measure: Adverse reactions to TENS unit
timeFrame: From date of randomization until date of discharge, assessed up to 1 month
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Nicole Kurata
state: Hawaii
Study officials:
affiliation: Physician
name: Kelly Yamasato
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.