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Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

Primary Purpose

Opioid Use, Auriculotherapy, Pain, Abdominal

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NSS-2 BRIDGE
Sham NSS-2 BRIDGE
Sponsored by
Jacques E. Chelly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring anesthesiology, auricular neurostimulation, auriculotherapy, open surgery, opioids, pain management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Over 18 years of age
  • Scheduled for elective open primary abdominal and pelvic colorectal cancer resection surgical procedures requiring at least 5 days at University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, Magee Woman's Hospital, or Passavant Hospital and following the standard Enhanced Recovery After Surgery (ERAS) protocol

Exclusion Criteria:

  • Dementia, delirium, major anxiety, depression, catastrophizing and cognitive disorders as determined based on the medical history of the subject and their current treatment. The anxiety, depression, and catastrophizing scores will help to confirm the medical evaluation. The PI or Co-I will be the one making the determination and who will make these determinations. Subjects who's T-score on these baseline assessments is >57 will be considered to have a clinically significant diagnosis.
  • Chronic pain condition or chronic opioid use defined as daily use of 60 mg of oral opioid equivalent (pain will be measured using a verbal scale, 0= no pain and 10= worst pain imaginable)
  • Allergy to medication listed in the protocol (local anesthetic, opioid, and non-opioid medication)
  • Alcohol abuse (defined as daily use of more than 1 liter of wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs) for at least 3 months
  • Contraindication or refusal of peripheral nerve block
  • Surgical procedure performed laparoscopically or with an expected hospitalization lasting less than 5 days
  • Non elective surgery
  • Pregnancy
  • Contraindication for use of NBD® (including patients with cardiac pacemaker, hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema)
  • History of prior abdominal surgery

Sites / Locations

  • University of Pittsburgh Medical Center - Magee-Womens Hospital
  • University of Pittsburgh Medical Center - Shadyside HospitalRecruiting
  • University of Pittsburgh Medical Center - Passavant Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

NSS-2 BRIDGE device

Placebo Bridge

Arm Description

This experimental arm involves the use of the NSS-2 BRIDGE device, which is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. It will be placed on the subject immediately after surgery and worn for 5 days. It is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.

The sham group involves the use of 3 non-active points, or "nonfunctional points." The sham device will be placed on the subject immediately post-operatively and worn for 5 days just like the active group.

Outcomes

Primary Outcome Measures

Opioid Consumption
Assess how the use of the NSS-2 BRIDGE Device over 5 days stimulation period affect the participant's total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery.

Secondary Outcome Measures

Post-operative pain rating using a numerical rating scale
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Area under the curve of post-operative pain rating using a numerical rating scale
Area under the curve of Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome, between 1-hour post NBD placement and day 5
Post-operative nausea and vomiting rating
Numerical Rating Scale (NRS) nausea scores on a scale from 0-10, with 0 being no nausea, 5 being moderate nausea and 10 being the worst imaginable nausea and vomiting. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Pre-operative emotional distress related to anxiety
Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Post-operative change in emotional distress related to anxiety
Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Pre-operative emotional distress related to depression
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Post-operative change in emotional distress related to depression
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Pre-operative sleep disturbance
Pre-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days.
Post-operative change in sleep disturbance
Post-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days.
Pre-operative pain rating using the Pain Catastrophizing Scale
Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Change in post-operative pain rating using the Pain Catastrophizing Scale
Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Pre-operative Brief Symptom Index Somatization Scale
The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely.
Change in the Brief Symptom Index Somatization Scale
The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely.
Time to Oral Intake
Evaluate time to oral intake post-operative.
Time to Ambulation
Evaluate time to ambulation, walking greater than 15 feet
Time to discharge from the recovery unit
Evaluate the time to discharge from the recovery unit (PACU) post-operatively
Length of hospital stay
Evaluate time to hospital discharge from out of OR time
Device tolerability
Participants will rate on a scale of 0 to 10, 0 being completely tolerable and 10 being completely intolerable.
Overall Patient Satisfaction
Participants will be asked to assess their overall satisfaction upon discharge on a scale of 0 (least satisfaction) to 10 (highest satisfaction) at the time of discharge

Full Information

First Posted
August 11, 2022
Last Updated
May 9, 2023
Sponsor
Jacques E. Chelly
Collaborators
Masimo Corporation, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05506878
Brief Title
Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
Official Title
Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2022 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jacques E. Chelly
Collaborators
Masimo Corporation, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The NSS-2 BRIDGE® device (NSS stands for Neuro-Stimulation System) is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. Because the stimulation of the nerves of the ear by the NSS-2 BRIDGE® device (NBD®) has been shown to modulate pain pathways in rodents, decrease abdominal pain in adolescents with inflammatory bile syndrome and due to the results of our preliminary pilot study, the investigators hypothesized that this technique may also be effective in reducing the requirement for postoperative opioids and provide a non-pharmacological alternative to perioperative opioid use. To establish the role that the stimulation of the nerves of the ear may have in reducing postoperative opioid requirement, the investigators are proposing to conduct a randomized, placebo controlled study in patients undergoing open abdominal or pelvic surgery requiring at least 5 days of hospitalization. Subjects who have signed an informed consent will be randomized in 2 groups (active NBD® group or inactive NBD® group). Furthermore, since preoperative and postoperative mood disorders have been shown to increase postoperative pain levels and opioid requirement by up to 50%, the investigators further hypothesize that the stimulation of the ear nerves by the NSS-2 BRIDGE® effects may be in part mediated by a reduction of the level of anxiety, depression and catastrophizing as assessed using validated questionnaires.
Detailed Description
It is established that the perioperative prescription of opioids, including doses prescribed after discharge from the hospitals, is an important contributor to the current opioid epidemic. Although many factors have been implicated including history of addiction, mood disorders and the type of surgery, the quantity and duration of opioid treatment play an important role in a patient's development of opioid use disorder (OUD). Despite recommendations by the majority of surgery and anesthesiology professionals to limit the perioperative use of opioids, and to favor the use of non-opioid analgesics, OUD remains a serious concern. Consequently, developing alternative techniques to minimize the perioperative use of opioids is critical in the fight against the current opioid epidemic. Auriculotherapy, a form of acupuncture is an ancient technique used to treat many conditions, including pain. Its mechanism of action is believed to be primarily via the stimulation of the branches of the vagal, trigeminal, glossopharyngeal, hypogastric, facial and superficial cervical plexus nerves innervating which secondarily modulate the pain pathway and the limbic system at the level of the brainstem, spin and central nervous system. However, the use of auriculotherapy has been limited in part by the requirement for long and specific training and the lack of well-designed clinical trials demonstrating its effectiveness. This study design is based on the high frequency of OUD following surgery for cancer and the positive results from our exploratory Institutional Review Board (IRB)- approved, randomized and placebo-controlled pilot study that assessed the effects of the NSS-2 BRIDGE® device on perioperative pain and opioid requirement in different surgical oncology models. This was a study that included subjects undergoing both open and laparoscopic procedures of different types of surgeries for abdominal cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Auriculotherapy, Pain, Abdominal, Cancer Pain
Keywords
anesthesiology, auricular neurostimulation, auriculotherapy, open surgery, opioids, pain management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Active device versus Sham Device
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
3 researchers have been appointed to randomization and are not participating in any part of the study other than treatment allocation. The researcher applying the device will not know the treatment allocation, and everyone else (participant, care provider, investigator and outcomes assessor) will be blinded to treatment allocation as well.
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NSS-2 BRIDGE device
Arm Type
Active Comparator
Arm Description
This experimental arm involves the use of the NSS-2 BRIDGE device, which is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. It will be placed on the subject immediately after surgery and worn for 5 days. It is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
Arm Title
Placebo Bridge
Arm Type
Sham Comparator
Arm Description
The sham group involves the use of 3 non-active points, or "nonfunctional points." The sham device will be placed on the subject immediately post-operatively and worn for 5 days just like the active group.
Intervention Type
Device
Intervention Name(s)
NSS-2 BRIDGE
Other Intervention Name(s)
Bridge
Intervention Description
NBD® will be applied to either the right or left ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation. Once the device is placed, subjects will be asked to perform a "pinch test" throughout the duration of their time wearing the device. To perform the "pinch test" subjects must pinch down on the electrodes and ground to ensure the electrodes are still placed in their designated locations and have not come loose.
Intervention Type
Device
Intervention Name(s)
Sham NSS-2 BRIDGE
Other Intervention Name(s)
Placebo
Intervention Description
Sham NBD® will be applied to either the left or right ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Assess how the use of the NSS-2 BRIDGE Device over 5 days stimulation period affect the participant's total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery.
Time Frame
Over the 5 day stimulation period of the device
Secondary Outcome Measure Information:
Title
Post-operative pain rating using a numerical rating scale
Description
Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Time Frame
1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
Title
Area under the curve of post-operative pain rating using a numerical rating scale
Description
Area under the curve of Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome, between 1-hour post NBD placement and day 5
Time Frame
1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
Title
Post-operative nausea and vomiting rating
Description
Numerical Rating Scale (NRS) nausea scores on a scale from 0-10, with 0 being no nausea, 5 being moderate nausea and 10 being the worst imaginable nausea and vomiting. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Time Frame
1 hour post NBD placement, days 1, 2, 3, 4, & 5 post-operative
Title
Pre-operative emotional distress related to anxiety
Description
Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Baseline, pre-surgery
Title
Post-operative change in emotional distress related to anxiety
Description
Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Title
Pre-operative emotional distress related to depression
Description
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Baseline, pre-surgery
Title
Post-operative change in emotional distress related to depression
Description
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Time Frame
Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Title
Pre-operative sleep disturbance
Description
Pre-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days.
Time Frame
Baseline, pre-surgery
Title
Post-operative change in sleep disturbance
Description
Post-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days.
Time Frame
Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Title
Pre-operative pain rating using the Pain Catastrophizing Scale
Description
Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Time Frame
Baseline, pre-surgery
Title
Change in post-operative pain rating using the Pain Catastrophizing Scale
Description
Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Time Frame
Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Title
Pre-operative Brief Symptom Index Somatization Scale
Description
The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely.
Time Frame
Baseline, pre-surgery
Title
Change in the Brief Symptom Index Somatization Scale
Description
The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely.
Time Frame
Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Title
Time to Oral Intake
Description
Evaluate time to oral intake post-operative.
Time Frame
Day of surgery up to 5 days
Title
Time to Ambulation
Description
Evaluate time to ambulation, walking greater than 15 feet
Time Frame
Day of surgery up to 5 days
Title
Time to discharge from the recovery unit
Description
Evaluate the time to discharge from the recovery unit (PACU) post-operatively
Time Frame
Day of surgery up to 5 days
Title
Length of hospital stay
Description
Evaluate time to hospital discharge from out of OR time
Time Frame
Day of surgery up to 30 days
Title
Device tolerability
Description
Participants will rate on a scale of 0 to 10, 0 being completely tolerable and 10 being completely intolerable.
Time Frame
Time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative
Title
Overall Patient Satisfaction
Description
Participants will be asked to assess their overall satisfaction upon discharge on a scale of 0 (least satisfaction) to 10 (highest satisfaction) at the time of discharge
Time Frame
Day of Surgery through discharge or post-operative day 30, whichever comes first

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Over 18 years of age Scheduled for elective open primary abdominal and pelvic colorectal cancer resection surgical procedures at UPMC Shadyside Hospital, UPMC Magee-Women's Hospital, or UPMC Passavant Hospital and following the standard ERAS protocol Expected hospital stay of approximately 5 days Exclusion Criteria: Patients who are considered by the medical or surgical team to not be able to give consent Clinical evidence of anxiety, depression, including suicidal ideation. The diagnostic will be based on medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject after the subject undergoes psychosocial testing included in the protocol and that corresponding scores have been established. These tests will only be conducted after the patient has signed an informed consent form. Chronic pain condition that at the discretion of the PI, should exclude the subject from participating -or- chronic opioid use defined as daily use of 60 mg of oral opioid equivalent. The diagnostic will be based on the medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject. True allergy to all opioid medications. The diagnostic will be based on the medical history, and the determination of the symptoms associated with the recorded allergy. The PI or Co-I will be the one making the determination to enroll the subject. History of or current alcohol abuse (defined as daily use of more than 1 liter of wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs) for at least 3 months. The PI or Co-I will be the one making the determination to enroll the subject. Surgical procedure performed laparoscopically Non elective surgery Pregnancy Contraindication for use of NBD® (including patients with cardiac pacemaker, hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema) Patients admitted into the ICU post-surgery, intubated, and/or receiving fentanyl infusion for sedation. Rapid recovery surgeries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Monroe, MPH, MBA
Phone
412-623-6382
Email
monroeal@upmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carley Siedlecki, MPH
Phone
412-623-2706
Email
siedleckic@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques E Chelly, MD, PhD, MBA
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center - Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace K Lim, MD, MS
Email
limgk2@upmc.edu
Facility Name
University of Pittsburgh Medical Center - Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques E Chelly, MD, PhD, MBA
Phone
412-623-6904
Email
chelje@anes.upmc.edu
Facility Name
University of Pittsburgh Medical Center - Passavant Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Lin, MD
Email
linc4@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
There will be annual NIH reports, and publicly sharing de-identified data with NIH.
IPD Sharing Time Frame
Every 6 months for 4 years.
IPD Sharing Access Criteria
The PI will be ultimately responsible for coordinating, obtaining and sharing de-identified Electronic Health Record (EHR)-based and electronically reported and prospectively collected clinical and outcome data.

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Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

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