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The current opioid epidemic has led to a renewed interest in exploring non-pharmacological techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory depression, immunosuppression, constipation, and most recently, addiction. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. Therefore, in order to combat this growing health crisis at the ground level, it is incumbent upon the medical community to explore alternative methods of pain control to treat the surgical population in order to reduce the incidence of post-operative opioid addiction.
Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing research has shown to be effective as a complementary method of pain management. While PNFS is not a novel concept, clinical indications of auricular field stimulation have been limited in the past due to requirement of bulky, stationary and non-disposable stimulators and electrodes. These technological limitations made it difficult to establish the real clinical potential of auricular stimulation for the perioperative management of pain in surgical patients, despite the demonstration that auriculotherapy has been shown to relieve pain in the postoperative setting.
The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include abdominal pain, anxiety and post-operative nausea and vomiting; conditions which are also present following major oncologic abdominal surgery. The use of the NSS-2 BRIDGE device has been demonstrated to provide significant analgesia in patients with abdominal pain syndrome, and clinical trials are ongoing to assess the benefit of this approach for post-operative pain management. As compared to the present use of opioids for perioperative pain management, the use of a complementary, non-pharmacologic approach offers the advantage of analgesia without the associated side effects.
Potential subjects (from both the prospective interventional and control groups) will be recruited in the pre-surgical clinic of the surgical oncology group at UPMC Shadyside once they are scheduled for major abdominal surgery. Patients will be asked for their interest in pursuing a research study that involves wearing a percutaneous, auricular field stimulator for five days as a supplementary method of post-operative pain control. Patients who agree to participate in the trial will sign an IRB approved Informed Consent Form.
Once patient has signed the Informed Consent to participate in this pilot study, demographic information and medical history will be collected from each participant on the day of surgery. The NSS-2 BRIDGE device will be applied to the ear by Dr. Jacques Chelly or Research Coordinator Amy Monroe in the immediate post-operative setting (PACU), as Dr. Chelly and Amy Monroe have both completed the necessary training required by the company to apply the device. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol, however, the patient will be made aware at the time of consent and throughout the trial that they can drop out of the study at any time if they do not like wearing the NSS- 2 BRIDGE device.
Randomization of both groups will occur by assigning the participant a subject ID number, and this ID number will correspond to a treatment allocation based on a pre-designed randomization schema. This treatment allocation (intervention/control) will be contained in a sealed, opaque, envelope with the subject ID number that is designated on envelope. The master randomization list will be created and held by an independent data monitor who will both create and hold the master randomization list.
The patient will be assessed 12, 24, 48, 72, 96 and 120 hours post-operatively to collect total opioid consumption, incidence of adverse events, and verbal pain scores. Additional data that will be collected includes total non-narcotic analgesic consumption, time to readiness for discharge from PACU, time to bowel movement, time to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission to the hospital, percentage of patients readmitted because of pain related issues, overall patient satisfaction, and patient satisfaction relating to pain management. When the patient is discharged from the hospital, they will be asked to complete a patient satisfaction survey. For patients discharged with the device attached, removal instructions and pre-paid return envelope will be given to patient to remove the device at 120 hours and send back to the hospital. The patient will be contacted 3 months post-operatively to again assess patient satisfaction with the pain management after surgery, and to assess functional recovery.
Post-operative nausea and/or vomiting will be evaluated by nausea score (0-10). Frequency of emesis and rescue antiemetic requirement will be collected per the institution's standard of care and transcribed from the medical record by research staff.
Standard opioid conversion table will be used to convert the oral and IV narcotic utilized by the patients to oral morphine equivalent doses (OME) for analysis purposes.
Time to patient-controlled analgesia (PCA) initiation on the floor will also be measured, as well as total PCA hydromorphone consumption over the 120-hour postoperative period.
Overall patient satisfaction and satisfaction of pain management during hospitalization will be measured by a numerical rating scale with 0- worst satisfaction and 10 being the best satisfaction. The patient satisfaction test will be administered by a member of the research team.
Number of patients with unsatisfactory pain relief defined as average Numerical Rating Scale (NRS) more than 5 with or without requirement of IVPCA for pain relief during the first 120 hours postoperative period will be compared between the two groups and form the primary outcome for the study.
Secondary outcome measures will include non-narcotic analgesic consumption, episodes of PONV, verbal pain scores, time to readiness for discharge from PACU, time to first bowel movement, time to oral intake (liquid and regular diet), time to hospital discharge, readmission to the hospital, percentage of patients readmitted because of pain related issues, functional recovery, overall patient satisfaction, and patient satisfaction relating to pain management. Overall patient satisfaction and satisfaction of pain management during hospitalization will be measured by a numerical rating scale with 0- worst satisfaction and 10 being the best satisfaction. This patient satisfaction score will administered by member of research team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSS-2 Bridge and ERAS Protocol | Experimental | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. |
|
| Sham NSS-2 BRIDGE and ERAS Protocol | Sham Comparator | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSS-2 Bridge | Device | NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing major abdominal surgery using the current SHY ERAS anesthesia protocol. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative. | 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain | 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. | 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques E. Chelly, MD | University of Pittsburgh Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Shadyside Hospital | Pittsburgh | Pennsylvania | 15232 | United States |
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A total of 65 subjects signed an informed consent. Among them 2 were screen failures and were not randomized because the surgery was cancelled. 10 were excluded because they were considered as major protocol violations. Consequently, a total of 53 patients were included in the final analysis.
Patients scheduled for surgery by a member of the surgical oncology group of UPMC Shadyside hospital. Patients were recruited in the pre-surgical clinic. After obtaining a signed informed consent the patients were randomized to either an active or a placebo NSS-2 BRIDGE device®. Each patient was made aware at the time of consent and throughout the study that they could ask to have the NSS-2 BRIDGE device® removed at any time.
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| ID | Title | Description |
|---|---|---|
| FG000 | NSS-2 Bridge and ERAS Protocol | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol. |
| FG001 | Sham NSS-2 BRIDGE and ERAS Protocol | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients undergoing open or laparoscopic abdominal surgical procedures
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| ID | Title | Description |
|---|---|---|
| BG000 | NSS-2 Bridge and ERAS Protocol | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Consumption | Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing major abdominal surgery using the current SHY ERAS anesthesia protocol. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative. | Subjects undergoing open or laparoscopic abdominal surgical procedures | Posted | Mean | Standard Deviation | oral morphine mg equivalents (OME) | 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative |
|
Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NSS-2 Bridge and ERAS Protocol | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel complications | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device dislodgement | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jacques E. Chelly, MD, PhD, MBA | University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine | 412-623-6382 | chelje@anes.upmc.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 1, 2018 | Sep 17, 2021 | Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 24, 2020 | Sep 17, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The only person unblinded to treatment allocation will be the individual applying the device to the patient.
| Sham NSS-2 BRIDGE | Device | NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol. |
|
| Non-narcotic Analgesic Consumption |
Investigate the efficacy of the NSS-2 Bridge Device in reducing perioperative consumption of non-narcotic analgesics. |
| Day of surgery through post-operative day 5 |
| Total Post-operative Nausea and Vomiting (PONV) | Evaluate the feeling of post-operative nausea and/or vomiting during the immediate 5 day post-operative period. This will be measured on a 10-point nausea scale from 0 (no nausea) to 10 (the worst nausea imaginable). The patient reports this score on a daily basis from post-op day 1 to post-op day 5 and the five daily scores will be added to calculate a total post-operative nausea score. The lowest possible total score is 0 and the highest possible total score is 50. A higher total score represents a worse outcome. | Day of surgery through post-operative day 5 |
| Length of Recovery Room Stay | Evaluate time to recovery room discharge from out of OR time. | Day of surgery through recovery room discharge, up to 300 minutes post-operative |
| Time to Ambulation (Walking Greater Than 15 Feet) | Evaluate length of time till ambulation from out of OR time. | Day of surgery through time of ambulation, up to 120 hrs post-operative |
| Time to First Bowel Movement | Evaluate length of time till first bowel movement from out of OR time. | Day of surgery through time of first bowel movement, up to 150 hrs post-operative |
| Time to Oral Intake | Evaluate length of time till oral intake from out of OR time. Time to oral intake is recorded as the first consumption of fluids, medication, or food by mouth. This is especially important for patients undergoing abdominal procedures as the time to oral intake can be delayed following such procedures. | Day of surgery through time of oral intake, up to 160 hrs post-operative |
| Length of Hospital Stay | Evaluate time to hospital discharge from out of OR time. | Day of surgery through discharge, up to 360 hrs post-operative |
| Overall Patient Satisfaction | Participants will be asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome. | Day of Surgery through time of discharge, up to 360 hrs post-operative |
| Satisfaction With Pain Management | Participants will be asked to assess their satisfaction with pain management upon discharge on 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome. | Day of surgery through time of discharge, up to 360 hrs post-operative |
| Functional Recovery | Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. The highest possible PCS-12 score is 56.57706 and the lowest possible score is 23.99938. The highest possible MCS-12 score is 60.75781 and the lowest possible score is 19.06444. Higher scores for both represent better functioning. | Day of surgery through 90 days post-operative. |
| BG001 | Sham NSS-2 BRIDGE and ERAS Protocol | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Surgery Type | Count of Participants | Participants |
|
| OG001 | Sham NSS-2 BRIDGE and ERAS Protocol | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol. |
|
|
| Secondary | Post-Operative Pain | 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. | Patients undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | scores on a scale | 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative |
|
|
|
| Secondary | Non-narcotic Analgesic Consumption | Investigate the efficacy of the NSS-2 Bridge Device in reducing perioperative consumption of non-narcotic analgesics. | Subjects undergoing open or laparoscopic abdominal surgical procedures | Posted | Mean | Standard Deviation | milligrams | Day of surgery through post-operative day 5 |
|
|
|
| Secondary | Total Post-operative Nausea and Vomiting (PONV) | Evaluate the feeling of post-operative nausea and/or vomiting during the immediate 5 day post-operative period. This will be measured on a 10-point nausea scale from 0 (no nausea) to 10 (the worst nausea imaginable). The patient reports this score on a daily basis from post-op day 1 to post-op day 5 and the five daily scores will be added to calculate a total post-operative nausea score. The lowest possible total score is 0 and the highest possible total score is 50. A higher total score represents a worse outcome. | Subjects undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | scores on a scale | Day of surgery through post-operative day 5 |
|
|
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| Secondary | Length of Recovery Room Stay | Evaluate time to recovery room discharge from out of OR time. | Subjects undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | minutes | Day of surgery through recovery room discharge, up to 300 minutes post-operative |
|
|
|
| Secondary | Time to Ambulation (Walking Greater Than 15 Feet) | Evaluate length of time till ambulation from out of OR time. | Subjects undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | hours | Day of surgery through time of ambulation, up to 120 hrs post-operative |
|
|
|
| Secondary | Time to First Bowel Movement | Evaluate length of time till first bowel movement from out of OR time. | Subjects undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | hours | Day of surgery through time of first bowel movement, up to 150 hrs post-operative |
|
|
|
| Secondary | Time to Oral Intake | Evaluate length of time till oral intake from out of OR time. Time to oral intake is recorded as the first consumption of fluids, medication, or food by mouth. This is especially important for patients undergoing abdominal procedures as the time to oral intake can be delayed following such procedures. | Subjects undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | hours | Day of surgery through time of oral intake, up to 160 hrs post-operative |
|
|
|
| Secondary | Length of Hospital Stay | Evaluate time to hospital discharge from out of OR time. | Subjects undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | hours | Day of surgery through discharge, up to 360 hrs post-operative |
|
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| Secondary | Overall Patient Satisfaction | Participants will be asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome. | Patients undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | score on a scale | Day of Surgery through time of discharge, up to 360 hrs post-operative |
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|
|
| Secondary | Satisfaction With Pain Management | Participants will be asked to assess their satisfaction with pain management upon discharge on 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome. | Patients undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | scores on a scale | Day of surgery through time of discharge, up to 360 hrs post-operative |
|
|
|
| Secondary | Functional Recovery | Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. The highest possible PCS-12 score is 56.57706 and the lowest possible score is 23.99938. The highest possible MCS-12 score is 60.75781 and the lowest possible score is 19.06444. Higher scores for both represent better functioning. | Patients undergoing open or laparoscopic abdominal surgical procedures. | Posted | Mean | Standard Deviation | scores on a scale | Day of surgery through 90 days post-operative. |
|
|
|
| 0 |
| 26 |
| 4 |
| 26 |
| 0 |
| 26 |
| EG001 | Sham NSS-2 BRIDGE and ERAS Protocol | The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol. | 0 | 27 | 2 | 27 | 1 | 27 |
| Surgical complications | Surgical and medical procedures | Systematic Assessment |
|
| Organ morbidity | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| 72 Hours |
|
| 96 Hours |
|
| 120 Hours |
|
| Ibuprofen |
|
| Ketamine IV |
|
| Ketorolac |
|