Postoperative Pain
Conditions
Keywords
VATS, Video-Assisted Thoracotomy, Thoracic Surgery, Video-Assisted
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.
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.
Interventions
DEVICETENS 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pain Score | hour 1 to hour 48 after awakening from video-assisted thoracic surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 48 hours after awakening from video-assisted thoracic surgery | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from individuals undergoing video-assisted thoracic surgery at the Mayo Clinic in Rochester, Minnesota from March 18 through September 22, 2010.
Pre-assignment details
56 subjects enrolled, but 14 subjects didn't start and receive the intervention. On the TENS Unit arm, 1 went straight to the ICU, 1 refused stating no pain to treat, and 4 did not have a VATS or had a thoracotomy. On the control arm, 1 did not have a VATS, 1 had an defibrillator, 3 went straight to the ICU, and 3 did not get started by nursing.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| Control Arm This arm will have standard care for their post operative pain control. | 20 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subject had a pacemaker | 0 | 1 |
| Overall Study | TENS interfered with the cardiac monitor | 0 | 1 |
Baseline characteristics
| Characteristic | TENS Unit | Control Arm | Total |
|---|---|---|---|
| Age Continuous | 63 years | 63 years | 63 years |
| Region of Enrollment United States | 22 participants | 20 participants | 42 participants |
| Sex: Female, Male Female | 14 Participants | 9 Participants | 23 Participants |
| Sex: Female, Male Male | 8 Participants | 11 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
Primary
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.
Time frame: hour 1 to hour 48 after awakening from video-assisted thoracic surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENS Unit | Mean Pain Score | Hour 25 | 2.50 units on a scale | Standard Deviation 1.73 |
| TENS Unit | Mean Pain Score | Hour 1 | 4.55 units on a scale | Standard Deviation 3.02 |
| TENS Unit | Mean Pain Score | Hour 26 | 2.85 units on a scale | Standard Deviation 1.84 |
| TENS Unit | Mean Pain Score | Hour 4 | 3.55 units on a scale | Standard Deviation 3.05 |
| TENS Unit | Mean Pain Score | Hour 27 | 2.65 units on a scale | Standard Deviation 1.5 |
| TENS Unit | Mean Pain Score | Hour 14 | 3.85 units on a scale | Standard Deviation 2.32 |
| TENS Unit | Mean Pain Score | Hour 28 | 2.35 units on a scale | Standard Deviation 1.87 |
| TENS Unit | Mean Pain Score | Hour 9 | 3.05 units on a scale | Standard Deviation 2.42 |
| TENS Unit | Mean Pain Score | Hour 29 | 2.60 units on a scale | Standard Deviation 1.98 |
| TENS Unit | Mean Pain Score | Hour 15 | 3.55 units on a scale | Standard Deviation 2.21 |
| TENS Unit | Mean Pain Score | Hour 30 | 1.95 units on a scale | Standard Deviation 1.79 |
| TENS Unit | Mean Pain Score | Hour 6 | 2.75 units on a scale | Standard Deviation 2.2 |
| TENS Unit | Mean Pain Score | Hour 31 | 2.10 units on a scale | Standard Deviation 1.86 |
| TENS Unit | Mean Pain Score | Hour 16 | 3.55 units on a scale | Standard Deviation 2.4 |
| TENS Unit | Mean Pain Score | Hour 32 | 2.00 units on a scale | Standard Deviation 1.78 |
| TENS Unit | Mean Pain Score | Hour 10 | 2.95 units on a scale | Standard Deviation 2.24 |
| TENS Unit | Mean Pain Score | Hour 33 | 2.05 units on a scale | Standard Deviation 2.04 |
| TENS Unit | Mean Pain Score | Hour 17 | 2.70 units on a scale | Standard Deviation 1.75 |
| TENS Unit | Mean Pain Score | Hour 34 | 2.20 units on a scale | Standard Deviation 1.88 |
| TENS Unit | Mean Pain Score | Hour 3 | 4.30 units on a scale | Standard Deviation 2.94 |
| TENS Unit | Mean Pain Score | Hour 35 | 2.10 units on a scale | Standard Deviation 1.86 |
| TENS Unit | Mean Pain Score | Hour 18 | 2.95 units on a scale | Standard Deviation 2.06 |
| TENS Unit | Mean Pain Score | Hour 36 | 2.45 units on a scale | Standard Deviation 2.76 |
| TENS Unit | Mean Pain Score | Hour 11 | 3.25 units on a scale | Standard Deviation 2.4 |
| TENS Unit | Mean Pain Score | Hour 37 | 2.80 units on a scale | Standard Deviation 2.73 |
| TENS Unit | Mean Pain Score | Hour 19 | 2.95 units on a scale | Standard Deviation 2.01 |
| TENS Unit | Mean Pain Score | Hour 38 | 2.75 units on a scale | Standard Deviation 2.73 |
| TENS Unit | Mean Pain Score | Hour 7 | 2.80 units on a scale | Standard Deviation 2.17 |
| TENS Unit | Mean Pain Score | Hour 39 | 2.50 units on a scale | Standard Deviation 2.28 |
| TENS Unit | Mean Pain Score | Hour 20 | 3.15 units on a scale | Standard Deviation 2.25 |
| TENS Unit | Mean Pain Score | Hour 40 | 2.50 units on a scale | Standard Deviation 2.21 |
| TENS Unit | Mean Pain Score | Hour 12 | 3.85 units on a scale | Standard Deviation 3.03 |
| TENS Unit | Mean Pain Score | Hour 41 | 2.30 units on a scale | Standard Deviation 2.11 |
| TENS Unit | Mean Pain Score | Hour 21 | 3.20 units on a scale | Standard Deviation 2.29 |
| TENS Unit | Mean Pain Score | Hour 42 | 1.85 units on a scale | Standard Deviation 1.31 |
| TENS Unit | Mean Pain Score | Hour 5 | 2.90 units on a scale | Standard Deviation 2.43 |
| TENS Unit | Mean Pain Score | Hour 43 | 1.70 units on a scale | Standard Deviation 1.42 |
| TENS Unit | Mean Pain Score | Hour 22 | 3.10 units on a scale | Standard Deviation 2.32 |
| TENS Unit | Mean Pain Score | Hour 44 | 1.95 units on a scale | Standard Deviation 1.54 |
| TENS Unit | Mean Pain Score | Hour 13 | 3.50 units on a scale | Standard Deviation 2.61 |
| TENS Unit | Mean Pain Score | Hour 45 | 1.70 units on a scale | Standard Deviation 1.49 |
| TENS Unit | Mean Pain Score | Hour 23 | 2.75 units on a scale | Standard Deviation 2.05 |
| TENS Unit | Mean Pain Score | Hour 46 | 1.75 units on a scale | Standard Deviation 1.52 |
| TENS Unit | Mean Pain Score | Hour 8 | 3.10 units on a scale | Standard Deviation 2.38 |
| TENS Unit | Mean Pain Score | Hour 47 | 1.85 units on a scale | Standard Deviation 1.66 |
| TENS Unit | Mean Pain Score | Hour 24 | 2.95 units on a scale | Standard Deviation 1.88 |
| TENS Unit | Mean Pain Score | Hour 48 | 1.75 units on a scale | Standard Deviation 1.68 |
| TENS Unit | Mean Pain Score | Hour 2 | 4.30 units on a scale | Standard Deviation 3.28 |
| Control Arm | Mean Pain Score | Hour 48 | 2.35 units on a scale | Standard Deviation 2.23 |
| Control Arm | Mean Pain Score | Hour 3 | 3.95 units on a scale | Standard Deviation 1.73 |
| Control Arm | Mean Pain Score | Hour 4 | 4.25 units on a scale | Standard Deviation 1.59 |
| Control Arm | Mean Pain Score | Hour 5 | 3.80 units on a scale | Standard Deviation 1.51 |
| Control Arm | Mean Pain Score | Hour 6 | 3.45 units on a scale | Standard Deviation 1.99 |
| Control Arm | Mean Pain Score | Hour 7 | 3.60 units on a scale | Standard Deviation 2.16 |
| Control Arm | Mean Pain Score | Hour 8 | 4.0 units on a scale | Standard Deviation 1.86 |
| Control Arm | Mean Pain Score | Hour 9 | 4.20 units on a scale | Standard Deviation 2.09 |
| Control Arm | Mean Pain Score | Hour 10 | 3.45 units on a scale | Standard Deviation 2.09 |
| Control Arm | Mean Pain Score | Hour 11 | 3.55 units on a scale | Standard Deviation 2.11 |
| Control Arm | Mean Pain Score | Hour 12 | 4.05 units on a scale | Standard Deviation 2.54 |
| Control Arm | Mean Pain Score | Hour 13 | 3.85 units on a scale | Standard Deviation 2.6 |
| Control Arm | Mean Pain Score | Hour 1 | 3.85 units on a scale | Standard Deviation 2.39 |
| Control Arm | Mean Pain Score | Hour 14 | 2.90 units on a scale | Standard Deviation 1.92 |
| Control Arm | Mean Pain Score | Hour 15 | 2.60 units on a scale | Standard Deviation 1.98 |
| Control Arm | Mean Pain Score | Hour 16 | 2.80 units on a scale | Standard Deviation 2.07 |
| Control Arm | Mean Pain Score | Hour 17 | 2.90 units on a scale | Standard Deviation 1.62 |
| Control Arm | Mean Pain Score | Hour 18 | 3.05 units on a scale | Standard Deviation 1.54 |
| Control Arm | Mean Pain Score | Hour 19 | 2.50 units on a scale | Standard Deviation 1.67 |
| Control Arm | Mean Pain Score | Hour 20 | 2.55 units on a scale | Standard Deviation 1.36 |
| Control Arm | Mean Pain Score | Hour 21 | 3.05 units on a scale | Standard Deviation 2.11 |
| Control Arm | Mean Pain Score | Hour 22 | 2.70 units on a scale | Standard Deviation 1.81 |
| Control Arm | Mean Pain Score | Hour 23 | 2.45 units on a scale | Standard Deviation 1.67 |
| Control Arm | Mean Pain Score | Hour 24 | 2.45 units on a scale | Standard Deviation 1.91 |
| Control Arm | Mean Pain Score | Hour 25 | 2.45 units on a scale | Standard Deviation 1.82 |
| Control Arm | Mean Pain Score | Hour 26 | 2.45 units on a scale | Standard Deviation 1.82 |
| Control Arm | Mean Pain Score | Hour 27 | 2.40 units on a scale | Standard Deviation 1.98 |
| Control Arm | Mean Pain Score | Hour 28 | 2.60 units on a scale | Standard Deviation 2.14 |
| Control Arm | Mean Pain Score | Hour 29 | 2.70 units on a scale | Standard Deviation 1.84 |
| Control Arm | Mean Pain Score | Hour 30 | 2.40 units on a scale | Standard Deviation 1.96 |
| Control Arm | Mean Pain Score | Hour 31 | 2.45 units on a scale | Standard Deviation 1.93 |
| Control Arm | Mean Pain Score | Hour 32 | 2.30 units on a scale | Standard Deviation 1.92 |
| Control Arm | Mean Pain Score | Hour 33 | 2.20 units on a scale | Standard Deviation 2.14 |
| Control Arm | Mean Pain Score | Hour 34 | 2.35 units on a scale | Standard Deviation 2.23 |
| Control Arm | Mean Pain Score | Hour 35 | 2.00 units on a scale | Standard Deviation 1.92 |
| Control Arm | Mean Pain Score | Hour 36 | 2.10 units on a scale | Standard Deviation 2.5 |
| Control Arm | Mean Pain Score | Hour 37 | 2.60 units on a scale | Standard Deviation 2.33 |
| Control Arm | Mean Pain Score | Hour 38 | 2.45 units on a scale | Standard Deviation 2.04 |
| Control Arm | Mean Pain Score | Hour 39 | 2.45 units on a scale | Standard Deviation 2.14 |
| Control Arm | Mean Pain Score | Hour 40 | 2.55 units on a scale | Standard Deviation 1.96 |
| Control Arm | Mean Pain Score | Hour 41 | 2.50 units on a scale | Standard Deviation 2.01 |
| Control Arm | Mean Pain Score | Hour 42 | 2.50 units on a scale | Standard Deviation 2.31 |
| Control Arm | Mean Pain Score | Hour 43 | 2.65 units on a scale | Standard Deviation 2.3 |
| Control Arm | Mean Pain Score | Hour 44 | 2.70 units on a scale | Standard Deviation 2.16 |
| Control Arm | Mean Pain Score | Hour 45 | 2.55 units on a scale | Standard Deviation 2.09 |
| Control Arm | Mean Pain Score | Hour 46 | 2.50 units on a scale | Standard Deviation 1.93 |
| Control Arm | Mean Pain Score | Hour 47 | 2.40 units on a scale | Standard Deviation 2.01 |
| Control Arm | Mean Pain Score | Hour 2 | 3.80 units on a scale | Standard Deviation 2.09 |
Secondary
Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours
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.
Time frame: 24 hours and 48 hours after awakening from video-assisted thoracic surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TENS Unit | Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours | 24 hours | 90.19 mg of oral morphine | Standard Deviation 48.08 |
| TENS Unit | Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours | 48 hours | 47.50 mg of oral morphine | Standard Deviation 55.67 |
| Control Arm | Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours | 24 hours | 93.65 mg of oral morphine | Standard Deviation 89.65 |
| Control Arm | Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours | 48 hours | 69.68 mg of oral morphine | Standard Deviation 113.65 |
Comparison: Decrease in OME use in the TENS Unit during the first and second 24 hours.p-value: 0.005t-test, 2 sided
Comparison: Decrease in OME use in the Control Arm during the first and second 24 hours.p-value: 0.11t-test, 2 sided
Secondary
Satisfaction With Pain Control at 48 Hours
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.
Time frame: 48 hours after awakening from video-assisted thoracic surgery
Population: 11 participants on each arm did not complete the VAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 0 (very satisfied) | 2 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 1 | 1 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 2 | 0 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 3 | 1 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 4 | 2 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 5 | 1 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 6 | 1 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 7 | 0 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 8 | 0 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 9 | 1 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 10 | 0 participants |
| TENS Unit | Satisfaction With Pain Control at 48 Hours | Unknown | 11 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 10 | 0 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 0 (very satisfied) | 2 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 6 | 0 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 1 | 2 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 9 | 1 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 2 | 2 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 7 | 0 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 3 | 1 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Unknown | 11 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 4 | 0 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 8 | 0 participants |
| Control Arm | Satisfaction With Pain Control at 48 Hours | Satisfaction Score 5 | 1 participants |
p-value: 0.7t-test, 2 sided