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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deborah Engen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01046695
First received: January 11, 2010
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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.

Condition Intervention
Postoperative Pain
Device: TENS Unit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluating Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Postoperative Pain After Video-Assisted Thoracotomy Surgery (VATS)

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Mean Pain Score [ Time Frame: hour 1 to hour 48 after awakening from video-assisted thoracic surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours [ Time Frame: 24 hours and 48 hours after awakening from video-assisted thoracic surgery ] [ Designated as safety issue: No ]
    As subjects could have been prescribed many different analgesics, the amount of pain medication was converted to the standard oral morphine equivalents (OME), so that the mean dose needed could be compared.

  • Satisfaction With Pain Control at 48 Hours [ Time Frame: 48 hours after awakening from video-assisted thoracic surgery ] [ Designated as safety issue: No ]
    Pain control was measured by using a Visual Analog Scale (VAS) with a range from 0-10; with 0 being very satisfied and 10 being very dissatisfied.


Enrollment: 56
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TENS Unit

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
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.
Other Name: Transcutaneous Electrical Nerve Stimulation unit
No Intervention: Control Arm
This arm will have standard care for their post operative pain control.

Detailed Description:

Video-Assisted Thoracotomy (VATS) patient's post procedure pain is a significant problem that may delay the recovery of thoracic surgery patients. Without adequate control of pain, the patient's mobilization and ability to participate in bronchial hygiene is compromised increasing the risk for pulmonary complications and inhibiting the body's natural healing ability. When acute post VATS pain is poorly controlled, the incidence of chronic post VATS pain six months or longer after the surgery increases. Post-operative pain is controlled largely through the use of pain medications delivered by a variety of routes including: epidural, intravenous, and when able, oral. Medications used include opioids which have side effects such as nausea, dizziness, drowsiness and constipation that may further delay the patient's recovery and prolong the hospital stay.

Transcutaneous Electrical Nerve Stimulation (TENS) is a method of pain relief that uses cutaneously applied electrodes that deliver electrical signals to peripheral nerves through the intact skin. Treating pain with TENS results in the patient having a reduced perception of pain. The effectiveness of TENS is based on two mechanisms: 1) the gate control theory of pain relief where stimulation of myelinated sensory fibers disrupts neuronal processing in the substantia gelatinosa of the spinal cord, and 2) the stimulation-induced release of endogenous opioids, both in the central nervous system and the general circulation. The present practice for obtaining and applying a TENS unit on a patient for pain relief requires consultation with Physical Therapy who will come and assess the patient and then apply the TENS unit and make recommendations for settings and therapy. This process limits the response to only daytime and often results in a delay in initiation of treatment. After providing education and training it is anticipated that nurses could successfully apply a TENS unit and initiate therapy early in the immediate post operative period. The more timely application of a TENS unit to a post VATS patient could improve pain management outcomes for this population.

Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain by nurses trained in TENS therapy. 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 5 program options available included: #1. Alternate Ramped Burst (ARB) (Rate = 100 pps; Ramp Up Time = 0.5s; On Time = 5s; Off Time = 6s). #2. Simple Modulated Pulse (SMP) (Rate = 125 pps; Cycle Time = 12s; Span Percentage = 40%; Rate stays in the 2-10 pps range for 1/3 of the cycle time (4 seconds) as the rate modulates down to 2 pulses per second (pps) and then back up again. #3. Modulated Amplitude (MA) (Rate = 125 pps; Cycle Time = 1s; Span Percentage = 60%). #4. Simple Modulated Pulse (SMP) (Rate = 125 pps; Cycle Time = 12s; Span Percentage = 40%; Rate stays in the 2-10 pps range for 1/3 of the cycle time (4 seconds) as the rate modulates down to 2 pulses per second (pps) and then back up again). #5 Modulated Amplitude, MA (Rate = 125 pps; Cycle Time = 1s; Span Percentage = 60%). 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. Five minutes after initiation of TENS therapy and every hour there after - while patient was awake- for a total of 48 hours, the patient was reassessed by nursing staff and TENS settings were adjusted for patient comfort and pain control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046695

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Deborah J. Engen, O.T. Mayo Clinic
Principal Investigator: Dietlind L. Wahner-Roedler, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Deborah Engen, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01046695     History of Changes
Other Study ID Numbers: 10-000141
Study First Received: January 11, 2010
Results First Received: November 14, 2012
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
VATS
Video-Assisted Thoracotomy
Thoracic Surgery, Video-Assisted

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on November 27, 2014