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Behavioural Intervention
Nerve Stimulation for Postoperative Pain
N/A
Recruiting
Led By Jacques E Chelly, MD, PhD, MBA
Research Sponsored by Jacques E. Chelly
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Over 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, pre-surgery
Awards & highlights
Study Summary
This trial is a study to test whether a device that stimulates the nerves of the ear can reduce postoperative pain and the need for opioids.
Who is the study for?
This trial is for adults over 18 who are scheduled for elective open abdominal or pelvic surgery with a planned hospital stay of about 5 days. It's not suitable for those unable to consent, with mood disorders, chronic pain or opioid use, allergies to opioids, laparoscopic surgery patients, pregnant women, ICU post-surgery patients on sedation, those with rapid recovery surgeries, substance abuse history or contraindications like pacemakers.Check my eligibility
What is being tested?
The study tests the NSS-2 BRIDGE device that stimulates ear nerves and may reduce the need for opioids after surgery. Participants will be randomly assigned to either an active device group or a placebo (inactive) group. The trial also examines if nerve stimulation can lower anxiety and depression which might affect pain levels and opioid needs.See study design
What are the potential side effects?
Potential side effects aren't specified but could include discomfort at the site of stimulation on the ear. Since it's non-pharmacological there may be fewer systemic side effects compared to medications; however individual reactions such as skin irritation cannot be ruled out.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for colorectal cancer surgery at a specified UPMC hospital, following ERAS protocol.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, pre-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, pre-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid Consumption
Secondary outcome measures
Area under the curve of post-operative pain rating using a numerical rating scale
Change in post-operative pain rating using the Pain Catastrophizing Scale
Change in the Brief Symptom Index Somatization Scale
+16 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: NSS-2 BRIDGE deviceActive Control1 Intervention
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.
Group II: Placebo BridgePlacebo Group1 Intervention
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.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,465 Previous Clinical Trials
2,618,347 Total Patients Enrolled
Masimo CorporationIndustry Sponsor
111 Previous Clinical Trials
12,791 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,293 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery that was not planned in advance.I was in the ICU after surgery, on a breathing machine, or given fentanyl for sedation.I am scheduled for colorectal cancer surgery at a specified UPMC hospital, following ERAS protocol.I have been diagnosed with anxiety or depression, including thoughts of suicide.My surgery was done using small incisions and a camera.I do not have chronic pain or use high doses of opioids daily.I do not have a pacemaker, hemophilia, psoriasis vulgaris, or ear eczema.I am having surgery that requires quick recovery.I am over 18 years old.I am unable to give consent for medical procedures.You have a history of drinking more than 1 liter of wine or 3 shots of hard liquor every day, or using illicit drugs every day for at least 3 months. The main researcher will decide if you can join the study.
Research Study Groups:
This trial has the following groups:- Group 1: NSS-2 BRIDGE device
- Group 2: Placebo Bridge
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for this clinical trial?
"Clinicaltrials.gov reveals that this medical trial, first published on October 1st 2022 and last edited on August 16th 2022, is no longer looking for participants. Fortunately, there are 196 other trials actively recruiting potential candidates right now."
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