Trial Outcomes & Findings for Evaluating Transcutaneous Electrical Nerve Stimulation for Postoperative Pain After Video-Assisted Thoracotomy Surgery (NCT NCT01046695)
NCT ID: NCT01046695
Last Updated: 2012-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
56 participants
Primary outcome timeframe
hour 1 to hour 48 after awakening from video-assisted thoracic surgery
Results posted on
2012-12-19
Participant Flow
Subjects were recruited from individuals undergoing video-assisted thoracic surgery at the Mayo Clinic in Rochester, Minnesota from March 18 through September 22, 2010.
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.
Participant milestones
| Measure |
Control Arm
Once awake from surgery this arm had standard care for 48 hours for their postoperative pain control using each surgeons usual postoperative medications and procedures.
|
TENS Unit
Once awake from surgery this arm added the use of the TENS unit for 48 hours in addition to standard care for their postoperative pain control. The TENS unit was set to each patients individual preference which included intensity, frequency and the placement of where they wanted the electrodes.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Control Arm
Once awake from surgery this arm had standard care for 48 hours for their postoperative pain control using each surgeons usual postoperative medications and procedures.
|
TENS Unit
Once awake from surgery this arm added the use of the TENS unit for 48 hours in addition to standard care for their postoperative pain control. The TENS unit was set to each patients individual preference which included intensity, frequency and the placement of where they wanted the electrodes.
|
|---|---|---|
|
Overall Study
Subject had a pacemaker
|
0
|
1
|
|
Overall Study
TENS interfered with the cardiac monitor
|
0
|
1
|
Baseline Characteristics
Evaluating Transcutaneous Electrical Nerve Stimulation for Postoperative Pain After Video-Assisted Thoracotomy Surgery
Baseline characteristics by cohort
| Measure |
TENS Unit
n=22 Participants
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.
|
Control Arm
n=20 Participants
This arm will have standard care for their post operative pain control.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
63 years
n=93 Participants
|
63 years
n=4 Participants
|
63 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=93 Participants
|
20 participants
n=4 Participants
|
42 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: hour 1 to hour 48 after awakening from video-assisted thoracic surgeryPain 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.
Outcome measures
| Measure |
TENS Unit
n=20 Participants
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.
|
Control Arm
n=20 Participants
This arm will have standard care for their post operative pain control.
|
|---|---|---|
|
Mean Pain Score
Hour 1
|
4.55 units on a scale
Standard Deviation 3.02
|
3.85 units on a scale
Standard Deviation 2.39
|
|
Mean Pain Score
Hour 2
|
4.30 units on a scale
Standard Deviation 3.28
|
3.80 units on a scale
Standard Deviation 2.09
|
|
Mean Pain Score
Hour 3
|
4.30 units on a scale
Standard Deviation 2.94
|
3.95 units on a scale
Standard Deviation 1.73
|
|
Mean Pain Score
Hour 4
|
3.55 units on a scale
Standard Deviation 3.05
|
4.25 units on a scale
Standard Deviation 1.59
|
|
Mean Pain Score
Hour 5
|
2.90 units on a scale
Standard Deviation 2.43
|
3.80 units on a scale
Standard Deviation 1.51
|
|
Mean Pain Score
Hour 6
|
2.75 units on a scale
Standard Deviation 2.20
|
3.45 units on a scale
Standard Deviation 1.99
|
|
Mean Pain Score
Hour 7
|
2.80 units on a scale
Standard Deviation 2.17
|
3.60 units on a scale
Standard Deviation 2.16
|
|
Mean Pain Score
Hour 8
|
3.10 units on a scale
Standard Deviation 2.38
|
4.0 units on a scale
Standard Deviation 1.86
|
|
Mean Pain Score
Hour 9
|
3.05 units on a scale
Standard Deviation 2.42
|
4.20 units on a scale
Standard Deviation 2.09
|
|
Mean Pain Score
Hour 10
|
2.95 units on a scale
Standard Deviation 2.24
|
3.45 units on a scale
Standard Deviation 2.09
|
|
Mean Pain Score
Hour 11
|
3.25 units on a scale
Standard Deviation 2.40
|
3.55 units on a scale
Standard Deviation 2.11
|
|
Mean Pain Score
Hour 12
|
3.85 units on a scale
Standard Deviation 3.03
|
4.05 units on a scale
Standard Deviation 2.54
|
|
Mean Pain Score
Hour 13
|
3.50 units on a scale
Standard Deviation 2.61
|
3.85 units on a scale
Standard Deviation 2.60
|
|
Mean Pain Score
Hour 14
|
3.85 units on a scale
Standard Deviation 2.32
|
2.90 units on a scale
Standard Deviation 1.92
|
|
Mean Pain Score
Hour 15
|
3.55 units on a scale
Standard Deviation 2.21
|
2.60 units on a scale
Standard Deviation 1.98
|
|
Mean Pain Score
Hour 16
|
3.55 units on a scale
Standard Deviation 2.40
|
2.80 units on a scale
Standard Deviation 2.07
|
|
Mean Pain Score
Hour 17
|
2.70 units on a scale
Standard Deviation 1.75
|
2.90 units on a scale
Standard Deviation 1.62
|
|
Mean Pain Score
Hour 18
|
2.95 units on a scale
Standard Deviation 2.06
|
3.05 units on a scale
Standard Deviation 1.54
|
|
Mean Pain Score
Hour 19
|
2.95 units on a scale
Standard Deviation 2.01
|
2.50 units on a scale
Standard Deviation 1.67
|
|
Mean Pain Score
Hour 20
|
3.15 units on a scale
Standard Deviation 2.25
|
2.55 units on a scale
Standard Deviation 1.36
|
|
Mean Pain Score
Hour 21
|
3.20 units on a scale
Standard Deviation 2.29
|
3.05 units on a scale
Standard Deviation 2.11
|
|
Mean Pain Score
Hour 22
|
3.10 units on a scale
Standard Deviation 2.32
|
2.70 units on a scale
Standard Deviation 1.81
|
|
Mean Pain Score
Hour 23
|
2.75 units on a scale
Standard Deviation 2.05
|
2.45 units on a scale
Standard Deviation 1.67
|
|
Mean Pain Score
Hour 24
|
2.95 units on a scale
Standard Deviation 1.88
|
2.45 units on a scale
Standard Deviation 1.91
|
|
Mean Pain Score
Hour 25
|
2.50 units on a scale
Standard Deviation 1.73
|
2.45 units on a scale
Standard Deviation 1.82
|
|
Mean Pain Score
Hour 26
|
2.85 units on a scale
Standard Deviation 1.84
|
2.45 units on a scale
Standard Deviation 1.82
|
|
Mean Pain Score
Hour 27
|
2.65 units on a scale
Standard Deviation 1.50
|
2.40 units on a scale
Standard Deviation 1.98
|
|
Mean Pain Score
Hour 28
|
2.35 units on a scale
Standard Deviation 1.87
|
2.60 units on a scale
Standard Deviation 2.14
|
|
Mean Pain Score
Hour 29
|
2.60 units on a scale
Standard Deviation 1.98
|
2.70 units on a scale
Standard Deviation 1.84
|
|
Mean Pain Score
Hour 30
|
1.95 units on a scale
Standard Deviation 1.79
|
2.40 units on a scale
Standard Deviation 1.96
|
|
Mean Pain Score
Hour 31
|
2.10 units on a scale
Standard Deviation 1.86
|
2.45 units on a scale
Standard Deviation 1.93
|
|
Mean Pain Score
Hour 32
|
2.00 units on a scale
Standard Deviation 1.78
|
2.30 units on a scale
Standard Deviation 1.92
|
|
Mean Pain Score
Hour 33
|
2.05 units on a scale
Standard Deviation 2.04
|
2.20 units on a scale
Standard Deviation 2.14
|
|
Mean Pain Score
Hour 34
|
2.20 units on a scale
Standard Deviation 1.88
|
2.35 units on a scale
Standard Deviation 2.23
|
|
Mean Pain Score
Hour 35
|
2.10 units on a scale
Standard Deviation 1.86
|
2.00 units on a scale
Standard Deviation 1.92
|
|
Mean Pain Score
Hour 36
|
2.45 units on a scale
Standard Deviation 2.76
|
2.10 units on a scale
Standard Deviation 2.5
|
|
Mean Pain Score
Hour 37
|
2.80 units on a scale
Standard Deviation 2.73
|
2.60 units on a scale
Standard Deviation 2.33
|
|
Mean Pain Score
Hour 38
|
2.75 units on a scale
Standard Deviation 2.73
|
2.45 units on a scale
Standard Deviation 2.04
|
|
Mean Pain Score
Hour 39
|
2.50 units on a scale
Standard Deviation 2.28
|
2.45 units on a scale
Standard Deviation 2.14
|
|
Mean Pain Score
Hour 40
|
2.50 units on a scale
Standard Deviation 2.21
|
2.55 units on a scale
Standard Deviation 1.96
|
|
Mean Pain Score
Hour 41
|
2.30 units on a scale
Standard Deviation 2.11
|
2.50 units on a scale
Standard Deviation 2.01
|
|
Mean Pain Score
Hour 42
|
1.85 units on a scale
Standard Deviation 1.31
|
2.50 units on a scale
Standard Deviation 2.31
|
|
Mean Pain Score
Hour 43
|
1.70 units on a scale
Standard Deviation 1.42
|
2.65 units on a scale
Standard Deviation 2.30
|
|
Mean Pain Score
Hour 44
|
1.95 units on a scale
Standard Deviation 1.54
|
2.70 units on a scale
Standard Deviation 2.16
|
|
Mean Pain Score
Hour 45
|
1.70 units on a scale
Standard Deviation 1.49
|
2.55 units on a scale
Standard Deviation 2.09
|
|
Mean Pain Score
Hour 46
|
1.75 units on a scale
Standard Deviation 1.52
|
2.50 units on a scale
Standard Deviation 1.93
|
|
Mean Pain Score
Hour 47
|
1.85 units on a scale
Standard Deviation 1.66
|
2.40 units on a scale
Standard Deviation 2.01
|
|
Mean Pain Score
Hour 48
|
1.75 units on a scale
Standard Deviation 1.68
|
2.35 units on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: 24 hours and 48 hours after awakening from video-assisted thoracic surgeryAs 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.
Outcome measures
| Measure |
TENS Unit
n=20 Participants
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.
|
Control Arm
n=20 Participants
This arm will have standard care for their post operative pain control.
|
|---|---|---|
|
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
|
93.65 mg of oral morphine
Standard Deviation 89.65
|
|
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
|
69.68 mg of oral morphine
Standard Deviation 113.65
|
SECONDARY outcome
Timeframe: 48 hours after awakening from video-assisted thoracic surgeryPopulation: 11 participants on each arm did not complete the VAS.
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.
Outcome measures
| Measure |
TENS Unit
n=20 Participants
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.
|
Control Arm
n=20 Participants
This arm will have standard care for their post operative pain control.
|
|---|---|---|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 8
|
0 participants
|
0 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 0 (very satisfied)
|
2 participants
|
2 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 1
|
1 participants
|
2 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 2
|
0 participants
|
2 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 3
|
1 participants
|
1 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 4
|
2 participants
|
0 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 5
|
1 participants
|
1 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 6
|
1 participants
|
0 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 7
|
0 participants
|
0 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 9
|
1 participants
|
1 participants
|
|
Satisfaction With Pain Control at 48 Hours
Satisfaction Score 10
|
0 participants
|
0 participants
|
|
Satisfaction With Pain Control at 48 Hours
Unknown
|
11 participants
|
11 participants
|
Adverse Events
TENS Unit
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TENS Unit
n=22 participants at risk
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.
|
Control Arm
n=20 participants at risk
This arm will have standard care for their post operative pain control.
|
|---|---|---|
|
Cardiac disorders
TENS interfered with cardiac monitor
|
4.5%
1/22 • Number of events 1 • Subjects were followed for adverse events for 48 hours after the video-assisted thoracotomy surgery.
|
0.00%
0/20 • Subjects were followed for adverse events for 48 hours after the video-assisted thoracotomy surgery.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place