Evaluating Transcutaneous Electrical Nerve Stimulation for Postoperative Pain After Video-Assisted Thoracotomy Surgery

NCT01046695 | Completed Results

• 1 other identifier: 10-000141
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

We propose to evaluate the use of Transcutaneous Electrical Nerve Stimulation (TENS) in patients having undergone Video-Assisted Thoracotomy Surgery (VATS) with the aim to determine if:

• Nurses will be able to apply TENS effectively and in a timely manner to post VATS patients.
• Use of TENS immediately after thoracic surgery and for the first 48 hours will add to patient's pain control.
• Tens will reduce medication use.
• Tens will reduce nausea and vomiting.

Conditions

Postoperative Pain

Keywords

VATS; Video-Assisted Thoracotomy; Thoracic Surgery, Video-Assisted

Outcome Measures

Primary Outcomes (1)

• Mean Pain Score

  Pain was measured by using the Visual Analog Scale (VAS) with a range from 1-10; with 0 being no pain and 10 being severe pain. Pain scores were measured from hour 1 to hour 48 for each patient. Some scores were missed when patients were asleep. In these cases, the previous score was used.

  hour 1 to hour 48 after awakening from video-assisted thoracic surgery

Secondary Outcomes (2)

• Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours

  24 hours and 48 hours after awakening from video-assisted thoracic surgery

• Satisfaction With Pain Control at 48 Hours

  48 hours after awakening from video-assisted thoracic surgery

Study Arms (2)

TENS Unit

ACTIVE COMPARATOR

This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control. Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation.

Device: TENS Unit

Control Arm

NO INTERVENTION

This arm will have standard care for their post operative pain control.

Interventions

TENS Unit DEVICE

TENS is a method of pain relief that uses a battery operated electronic device with cutaneously applied electrodes that deliver electrical signals to peripheral nerves through the intact skin. The TENS Unit is a low voltage system that will only be used to a level to create alternative to pain sensation and will not create muscle response.

Also known as: Transcutaneous Electrical Nerve Stimulation unit

TENS Unit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18-100 able to give informed consent.
• Able to speak and understand English.

You may not qualify if:

• Too confused to provide data or not extubated within 48 hours after surgery.
• Unable to speak and understand English.
• Patients with active internal pacer wires, demand type implanted pacemakers or defibrillator.
• Transplant patients.
• Children, prisoners, any woman who is pregnant.
• Patients that are non-scheduled surgery cases or occurring Saturday or Sunday.
• Ventricular Assisted Device (VAD) patients.
• Know allergies or intolerance to TENS electrodes.
• Patients who have had the Da Vinci robotic assisted minimally invasive procedure.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.

  PMID: 25935320 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Deborah J. Engen, OT, CMT
• Organization: Mayo Clinic

engen.deborah@mayo.edu

507-255-5504

Study Officials

• Deborah J. Engen, O.T.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Dietlind L. Wahner-Roedler, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 19, 2012
• Results First Posted: December 11, 2012

Record last verified: 2012-12

Locations

US (1)