BRIDGE Device for Post-operative Pain Control

Not Applicable

Terminated

• Conditions: Liver Diseases; Liver Cirrhosis, Biliary; Liver Diseases, Alcoholic; Liver Failure; Pain, Postoperative; Transplant; Failure, Liver
• Interventions: Device: BRIDGE device

• Registration Number: NCT03265249
• Lead Sponsor: Duke University

Brief Summary

Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity. The investigators propose a pilot study to investigate the effects of auricular neurostimulation in patients receiving a liver transplantation. The investigator will investigate the effects of auricular neurostimulation with this novel device and compare it to the current standard of care for pain management following liver transplantation.

Detailed Description

This is a prospective, randomized study to determine the efficacy of the BRIDGE device in reducing pain and opioid use in patients following liver transplantation. Subjects will be randomized in a 1:1 ration to one of the below groups:

Group 1: BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia

Group 2: Subjects will receive the standard of care pain control analgesia

Study Timeline

• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Study Start: 2018-02-12
• Primary Completion: 2020-04-03
• Study Completion: 2020-04-03
• Disposition First Submitted: 2022-01-21
• Status Verified: 2023-01
• Results First Submitted: 2023-01-30
• Results First Submitted QC: 2023-03-06
• Last Update Submitted: 2023-03-06
• Results First Posted: 2023-03-08
• Disposition First Posted: 2023-03-08
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Inclusion criteria:

  • ≥18 years of age but <70 years of age
  • Actively listed for isolated liver transplantation
  • Subject or legally authorized representative able to sign informed consent
  • Not currently treated with opioids or any medications that may interact with opioids
  • English speaking
  • Willing and able to participate and consent to this study

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Exclusion Criteria

• Diagnosis of acute liver failure or primary sclerosing cholangitis (PSC)
• Anticipated that the subject will require a new roux-en-y hepaticojejunostomy
• Current use of opioid use or other substance abuse.
• Chronic pain disorders
• Need for regional anesthesia (regional nerve blocks or epidurals)
• Adhesive allergy/sensitivity
• Subject admitted to the ICU at the time of transplant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	BRIDGE device	BRIDGE device will be placed prior to start of the surgery with standard of care pain control analgesia

Primary Outcome Measures

Name	Time	Method
Opioid Usage After Surgery as Measured by Total Milligrams of Morphine or Equivalent (MEQ)	up to day 30

Secondary Outcome Measures

Name	Time	Method
Pain Level	up to day 30	Evaluation of the pain score in the two groups (SOC and with device) at the end of surgery
Reduction in Nausea Scores as Measured by a 4-item Questionnaire Response	up to day 30	Determination of the intensity of nausea in the two groups (SOC and with device)
Reduction in Vomiting Scores as Measured by a 4-item Questionnaire Response	up to day 30	Determination of the intensity of vomiting in the two groups (SOC and with device)
Incidence of Post-operative Ileus Will be Measured by Need for Nasogastric Decompression for >48 Hours	up to 30 days	Determination of the presence of an ileus in the two groups (SOC and with device)
Reduction in Time for Return of Bowel Function as Measured by Length to Time of Bowel Functioning Return.	up to day 30	Evaluation of return of bowel function noting day of bowel movement occurrence in both groups.
Improved Post-operative Mobility as Measured by the Patient Symptom Surveys	up to 30 days	Determination of mobility with in the two groups (SOC and with device)
Reduction in Length of Hospital Stay as Measured by Days in Hospital	up to 30 days	Determination of length of hospital stay with in the two groups (SOC and with device)

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States