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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TENS Unit | Active Comparator |
| |
| Placebo TENS Unit | Placebo Comparator |
| |
| No TENS Unit | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) unit | Device | Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative narcotic consumption | Total postoperative narcotic consumption (measured in morphine equivalents) | First 60 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hospitalization | Length of stay in hospital | 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) |
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Inclusion Criteria:
- Women undergoing scheduled or non-urgent cesarean section
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Kurata | Contact | (808)577-3344 | nkurata@hawaii.edu | |
| Kelly Yamasato | Contact | kyamasat@hawaii.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kelly Yamasato | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nicole Kurata | Recruiting | Honolulu | Hawaii | 96826 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26996986 | Background | 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. | |
| 19158541 |
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Participants are randomized to one of three groups in parallel for the duration of the study
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| Placebo transcutaneous electrical nerve stimulation (TENS) unit | Device | Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit |
|
Pain scoring
| 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) | Pain control satisfaction | On post-operative days 1, 2, 3, and day of discharge, assessed up to 1 month |
| Adverse reactions to TENS unit | Adverse reactions to TENS unit | From date of randomization until date of discharge, assessed up to 1 month |
| 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. |
| 12600800 | Background | 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. |
| 26827847 | Background | 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. |
| 19370680 | Background | 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. |
| 35852266 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2023 | Oct 13, 2023 | 2 |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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