Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Analgesia Clinical Trial

Official title:

Transcutaneous Electrical Nerve Stimulation for Post-Cesarean Pain Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04399707
• Other study ID #: 2019-035
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2020
• Est. completion date: May 2021

Study information

• Verified date: May 2020
• Source: Hawaii Pacific Health
• Contact: Nicole Kurata
• Phone: (808)577-3344
• Email: nkurata[@]hawaii.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Cesarean Section
• Transcutaneous Electric Nerve Stimulation

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Nicole Kurata	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Hawaii Pacific Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. Erratum in: J Pain. 2016 Apr;17(4):508-10. Dosage error in article text. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative narcotic consumption	Total postoperative narcotic consumption (measured in morphine equivalents)	First 60 hours post-operatively
Secondary	Duration of hospitalization	Length of stay in hospital	From date of cesarean delivery until discharge from hospital, assessed up to 1 month
Secondary	Pain assessed by numeric analog scale (NAS) (0-10; 0: no pain at all, 10: worst imaginable pain)	Pain scoring	On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Secondary	Satisfaction with pain control assessed by NAS (0-10; 0: very dissatisfied, 10: very satisfied)	Pain control satisfaction	On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month
Secondary	Adverse reactions to TENS unit	Adverse reactions to TENS unit	From date of randomization until date of discharge, assessed up to 1 month

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