NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries

Summary

Participation Requirements

Description

An open-label, pilot study will investigate forty individuals, ten of which will be scheduled for total hip arthroplasty, ten will be scheduled for total knee arthroplasty, ten scheduled for kidney transplant and ten for bariatric surgery, will be approached and consented for this trial. Their data ...

An open-label, pilot study will investigate forty individuals, ten of which will be scheduled for total hip arthroplasty, ten will be scheduled for total knee arthroplasty, ten scheduled for kidney transplant and ten for bariatric surgery, will be approached and consented for this trial. Their data in regards to their post-operative pain, nausea, and analgesia use will be compared to 10 historic subjects who had the same surgeries in January (TKA/THA) or September (kidney transplant/bariatric) of 2019. The subjects who receive the NSS-2-BRIDGE will also be monitored for comfort with the device for the tolerability and feasibility of utilizing this device in the future to treat post-operative pain. Once a patient has given and signed informed consent to participate in the study, demographic information and medical history will be collected from each participant on the day of the joint replacement/kidney transplant/bariatric surgery. Data will be de-identified and kept in a locked cabinet in a locked office. The PI and the research coordinator have been trained in placing the NSS-2-BRIDGE and will apply the device in the immediate post-operative setting (post-anesthesia care unit, PACU). The device will be attached behind the ear with double-sided tape. It contains three electrodes which will be applied to the ear and a ground which will be placed on the patient's lobe. Each electrode and the ground will be secured with adhesive bandages. The patient will be informed at the time of consent and after the implantation of the device that they can have the device removed any time after its application. Once the device is placed patients will be asked to perform a "pinch test" throughout the duration of their time wearing the device. To perform the "pinch test" they must pinch down on the electrodes and ground to ensure they are still placed in their designated locations and have not come loose. As per standard of care, at 24, 48, 72, 96 and 120 hours post-operatively pain scores will be collected at rest and movement, total opioid consumption, as well as the devise tolerability. Additionally as per other pain pilot IRB approved projects, we shall also collect common medical information including time to bowel movement, PONV, time to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain related issues, quality of recovery after joint replacement, overall patient satisfaction, and patient satisfaction related to pain management. When the patient is discharged from the hospital, they will be asked to complete a patient satisfaction survey. If the patient should be discharged prior to 120 hours post-operatively, they will be asked to wear the device home. They will also be ask to remove the device at 120 hours (five days) after device placement and dispose of it in their home. We will provide removal instructions. Data post- hospital discharge regarding pain scores, opioid consumption, and device tolerability will be collected after discharge by calling the patient every day for 120 hr. following the placement of the device. At UPMC Shadyside, we expect the patients undergoing primary unilateral either total hip or total knee surgery to be discharged on the day of surgery, or the next day but no later than 48 hrs following surgery. Therefore, for the patients in whom a Bridge device will be placed following surgery, it will be possible to document, if during the 120 hrs following the placement of the device, the patient returned to the hospital because of pain. This will be documented in the patient chart and therefore will be available for review. Given that most post-bariatric patients are discharged at 72 hours or before, pain scores, opioid needs, and device tolerability at 96 and 120 hours will be collected from the patient by calling them after discharge. Participants will be called once daily up until day 5 and asked to report information. Phone calls to patients after discharge are consistent with routine clinical care. If the kidney transplant patient is discharged prior to 120 hours (5 days), they will also be called daily to record pain scores, opioid needs, and device tolerability for the time they are discharged up to 5 days post-device placement. As stated in the protocol, each patient will be discharged according to the standard protocol defined by the surgical team. Data collected for both historical and study subjects will be the base of the standard clinical data collected for any patient undergoing surgery at UPMC SDY, UPMC Montefiore and UPMC MWH. After the patient is discharged from the hospital data related to pain, nausea and vomiting and opioid consumption will be obtained by a daily phone call. The historical controls will include a medical chart review of patients from the Acute Perioperative Pain Service at UPMC Shadyside Hospital. Data collection includes total narcotic/non-opioid analgesic requirement, pain scores and nausea and vomiting after the surgery. Other information collected from the medical record will include age, race and medical history. Additionally, we will also collect common medical information including 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, readmission due to pain related issues. No Personal Health Identifiers will be collected from the historical controls. The subjects in whom the Bridge device will be placed will receive the same standard ERAS protocol as the patients who will be used as historical control. No power analysis will be performed. However, the tolerability of the placement of the bridge device (focus of this study) will be assessed using the pain scores. We will record pain scores before and after the placement of the Device (prior to leaving the recovering room, and at 24, 48, 72, 96 and 120 or until discharge from the hospital) and compare it to the historical data of pain scores recorded prior to discharge from the hospital.

Tracking Information