Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 6
- 主要终点
- Opioid Consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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. OR scheduled for a living-donor liver transplant surgery at UPMC Montefiore Hospital under the ERAS protocol.
- •Expected hospital stay of approximately 5 days
排除标准
- •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
- •Contraindication for use of NBD® (including patients with cardiac pacemaker, hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema)
- •Patients intubated with sedation, and/or receiving fentanyl infusion for sedation post-surgery.
- •Rapid recovery surgeries
- •Subjects with a diagnosed seizure disorder
- •Use of dexmedetomidine in the ICU
研究组 & 干预措施
NSS-2 BRIDGE device
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.
干预措施: NSS-2 BRIDGE (Device)
Placebo Bridge
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.
干预措施: Sham NSS-2 BRIDGE (Device)
结局指标
主要结局
Opioid Consumption
时间窗: (OME) at 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-operative
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.
次要结局
- Post-operative pain rating using a numerical rating scale(1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative)
- Area under the curve of post-operative pain rating using a numerical rating scale(1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative)
- Post-operative nausea and vomiting rating(1 hour post NBD placement, days 1, 2, 3, 4, & 5 post-operative)
- Pre-operative emotional distress related to anxiety(Baseline, pre-surgery)
- Post-operative change in emotional distress related to anxiety(Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative)
- Pre-operative emotional distress related to depression(Baseline, pre-surgery)
- Post-operative change in emotional distress related to depression(Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative)
- Pre-operative sleep disturbance(Baseline, pre-surgery)
- Post-operative change in sleep disturbance(Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative)
- Pre-operative pain rating using the Pain Catastrophizing Scale(Baseline, pre-surgery)
- Change in post-operative pain rating using the Pain Catastrophizing Scale(Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative)
- Pre-operative Brief Symptom Index Somatization Scale(Baseline, pre-surgery)
- Change in the Brief Symptom Index Somatization Scale(Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative)
- Time to Oral Intake(Day of surgery up to 5 days)
- Time to Ambulation(Day of surgery up to 5 days)
- Time to discharge from the recovery unit(Day of surgery up to 5 days)
- Length of hospital stay(Day of surgery up to 30 days)
- Device tolerability(Time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative)
- Overall Patient Satisfaction(Day of Surgery through discharge or post-operative day 30, whichever comes first)
- Total Opioid Consumption(Post-operative day 5, 1-month, and 3-months post-operative)
- Prescription Drug Monitoring Program (PDMP)(Post-operative day 90)
- Prescription Drug Monitoring Program (PDMP)(Post-operative day 30)
- Prescription Drug Monitoring Program (PDMP)(Post-operative day 60)
研究者
Jacques E. Chelly
Professor of Anesthesiology and Perioperative Medicine and Orthopedic Surgery Director, Regional Anesthesiology Fellowship Program
University of Pittsburgh