Pain, Postoperative
Conditions
Brief summary
The aim of this research study is to gather data regarding the feasibility of the Bridge system for the management of pain following total hip arthroplasty (THA).
Interventions
DEVICEBridge device
Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas.
DEVICESham device
The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses.
Sponsors
Masimo Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is 18 years of age or older * Subject scheduled for elective primary unilateral total hip arthroplasty (THA) * Subject opioid use is less than 60 milligram morphine equivalent for the last 30 days * Subject has given written informed consent to participate in the study
Exclusion criteria
* Subjects who are pregnant or breastfeeding * Subjects with cardiac pacemakers or other implanted devices (e.g. vagal nerve simulators), hemophilia or psoriasis vulgaris * Subjects with a history of active depression, anxiety or catastrophizing * Subjects with active alcoholism or drug abuse * Subjects with severe chronic pain condition that requires daily preoperative opioid dependence * Subjects deemed not suitable for the study at the discretion of the principal investigator * Subjects who are concurrently participating in any other research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Total Opioid Consumption Between Active and Sham Arms. | Day of surgery to Day 5 (120 hours) post-op | The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day of surgery to Day 5 (120 hours) post-op | Pain scores using a numerical scale will be collected at rest and movement and will be obtained prior to surgery, in the recovery room, prior to leaving the recovery room, every 6 hours during the first 24 hrs, and at 48, 72, 96 and 120 hours post-operatively. Subjects will use a 0-10 numeric scale (0 indicating no pain and 10 indicating extreme pain). |
| Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day of surgery to Day 5 (120 hours) post-op | Postoperative nausea and vomiting will be evaluated from immediately after surgery through postoperative day 5, using a 0-10 scale (0 indicating no nausea and 10 indicating extreme nausea). |
| Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30 | Day of surgery to post-operative day 30. | Functional recovery will be assessed daily from day of surgery to post-op day 5, using the Timed Up and Go assessment to assess mobility. |
| Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30 | Day of surgery to post-operative day 30. | Subjects will also complete the 12-Item Short Form Survey (SF-12) on Post-Op day 30 to evaluate quality of recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bridge Device The active Bridge device delivers electrical stimulation to the cranial and occipital nerves.
Bridge device: Bridge is a percutaneous nerve field stimulation device which uses alternating currents of stimulation over a large field and with higher voltage in order to influence central pain areas. | 2 |
| Sham Device The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses
Sham device: The sham device has the same appearance and will require the same placement technique as the Bridge (active) device but will not deliver electrical impulses. | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Bridge Device | Sham Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 4 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 3 |
Outcome results
Primary
Change in Total Opioid Consumption Between Active and Sham Arms.
The sample size is well below the threshold needed to reliably assess outcomes and perform statistical comparisons. As a result, we have provided the raw data for comparison of opioid consumption between the two groups.
Time frame: Day of surgery to Day 5 (120 hours) post-op
Population: The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed end-of-life by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample size have been reported. Further data reporting would be statistically inappropriate due to the sample size.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bridge Device | Change in Total Opioid Consumption Between Active and Sham Arms. | Oxycodone 5mg | 1 doses |
| Bridge Device | Change in Total Opioid Consumption Between Active and Sham Arms. | Tramadol 50mg | 0 doses |
| Bridge Device | Change in Total Opioid Consumption Between Active and Sham Arms. | Meloxicam 15mg | 0 doses |
| Sham Device | Change in Total Opioid Consumption Between Active and Sham Arms. | Oxycodone 5mg | 33 doses |
| Sham Device | Change in Total Opioid Consumption Between Active and Sham Arms. | Tramadol 50mg | 5 doses |
| Sham Device | Change in Total Opioid Consumption Between Active and Sham Arms. | Meloxicam 15mg | 7 doses |
Secondary
Change in Functional Recovery Between Active and Sham Arms Assessed Using the 12-Item Short Form Survey (SF-12) Collected on Post-Op Day 30
Subjects will also complete the 12-Item Short Form Survey (SF-12) on Post-Op day 30 to evaluate quality of recovery.
Time frame: Day of surgery to post-operative day 30.
Population: No data was collected for this outcome measure. The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed end-of-life by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample have been reported.
Secondary
Change in Functional Recovery Between Active and Sham Arms Assessed Using the Timed Up and Go (TUG) Assessment Collected on Post-Op Day 30
Functional recovery will be assessed daily from day of surgery to post-op day 5, using the Timed Up and Go assessment to assess mobility.
Time frame: Day of surgery to post-operative day 30.
Population: No data was collected for this outcome measure. The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed end-of-life by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample have been reported.
Secondary
Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale.
Pain scores using a numerical scale will be collected at rest and movement and will be obtained prior to surgery, in the recovery room, prior to leaving the recovery room, every 6 hours during the first 24 hrs, and at 48, 72, 96 and 120 hours post-operatively. Subjects will use a 0-10 numeric scale (0 indicating no pain and 10 indicating extreme pain).
Time frame: Day of surgery to Day 5 (120 hours) post-op
Population: The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed end-of-life by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample have been reported. Further data reporting would be statistically inappropriate due to the sample size.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 2 (48 hours) post-op | 4 score on a scale |
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 1 (24 hours) post-op | 8 score on a scale |
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 5 (120 hours) post-op | 4 score on a scale |
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 18 hours post-op | 7 score on a scale |
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 4 (96 hours) post-op | 3 score on a scale |
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 6 hours post-op | 9 score on a scale |
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 3 (72 hours) post-op | 4 score on a scale |
| Bridge Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 12 hours post-op | 7 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 4 (96 hours) post-op | 4 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 5 (120 hours) post-op | 1 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 12 hours post-op | 1 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 6 hours post-op | 1 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 18 hours post-op | 2 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 1 (24 hours) post-op | 0 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 2 (48 hours) post-op | 1 score on a scale |
| Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 3 (72 hours) post-op | 1 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 12 hours post-op | 7 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 1 (24 hours) post-op | 6 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 4 (96 hours) post-op | 5 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 3 (72 hours) post-op | 5 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 2 (48 hours) post-op | 4 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 18 hours post-op | 7 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 6 hours post-op | 7 score on a scale |
| Subject 3 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 5 (120 hours) post-op | 3 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 12 hours post-op | 4 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 1 (24 hours) post-op | 1 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 4 (96 hours) post-op | 2 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 2 (48 hours) post-op | 4 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 6 hours post-op | 5 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 5 (120 hours) post-op | 3 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 3 (72 hours) post-op | 3 score on a scale |
| Subject 4 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 18 hours post-op | 2 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 5 (120 hours) post-op | 3 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 6 hours post-op | 5 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 12 hours post-op | 8 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 1 (24 hours) post-op | 6 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 2 (48 hours) post-op | 5 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 3 (72 hours) post-op | 4 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | Day 4 (96 hours) post-op | 3 score on a scale |
| Subject 5 - Sham Device | Change in Pain Between Active and Sham Arms as Measured Using the Numeric Rating Scale. | 18 hours post-op | 6 score on a scale |
Secondary
Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale.
Postoperative nausea and vomiting will be evaluated from immediately after surgery through postoperative day 5, using a 0-10 scale (0 indicating no nausea and 10 indicating extreme nausea).
Time frame: Day of surgery to Day 5 (120 hours) post-op
Population: The study was terminated prematurely due to sponsor decision, with no clinical rationale for the termination. This was a feasibility study and the test device was deemed end-of-life by the manufacturer. Only 5 subjects were enrolled out of the 60 anticipated -2 with active devices and 3 with sham devices. All available demographic and outcome measure data from the limited sample have been reported. Further data reporting would be statistically inappropriate due to the sample size.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 12 hours post-op | 0 score on a scale |
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 4 (96 hours) post-op | 0 score on a scale |
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 18 hours post-op | 0 score on a scale |
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 2 (48 hours) post-op | 0 score on a scale |
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 6 hours post-op | 0 score on a scale |
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 5 (120 hours) post-op | 0 score on a scale |
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 3 (72 hours) post-op | 0 score on a scale |
| Bridge Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 1 (24 hours) post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 4 (96 hours) post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 6 hours post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 2 (48 hours) post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 12 hours post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 5 (120 hours) post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 1 (24 hours) post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 18 hours post-op | 0 score on a scale |
| Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 3 (72 hours) post-op | 0 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 6 hours post-op | 0 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 12 hours post-op | 0 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 18 hours post-op | 0 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 1 (24 hours) post-op | 3 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 2 (48 hours) post-op | 0 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 3 (72 hours) post-op | 0 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 4 (96 hours) post-op | 0 score on a scale |
| Subject 3 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 5 (120 hours) post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 2 (48 hours) post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 18 hours post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 3 (72 hours) post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 12 hours post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 5 (120 hours) post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 4 (96 hours) post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 6 hours post-op | 0 score on a scale |
| Subject 4 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 1 (24 hours) post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 1 (24 hours) post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 18 hours post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 2 (48 hours) post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 5 (120 hours) post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 4 (96 hours) post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | Day 3 (72 hours) post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 12 hours post-op | 0 score on a scale |
| Subject 5 - Sham Device | Change in Postoperative Nausea Between Active and Sham Arms as Measured Using a Postoperative Nausea and Vomiting Rating Scale. | 6 hours post-op | 0 score on a scale |