A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery: A Prospective, Randomized, Open Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement
研究概览
简要总结
Opioid addiction in post-operative patients is recognized but not fully understood; therefore, in order to address this growing crisis, it is essential to explore alternative approaches to managing pain and apply them to the surgical population. One potential non-opioid method of pain relief is the use of the nCAP Nano Patch, placed topically on the site of pain. The objective of this study is to investigate the efficacy of the nCAP Signal Relief Patch in reducing the perioperative opioid requirement in patients undergoing primary unilateral total hip or knee replacement surgery.
详细描述
After signing an informed consent, subjects will complete the PROMIS Emotional Distress - Anxiety - Short Form 8a before completing any other questionnaires. Subjects who have a raw score <19 will be enrolled in the study. Any subject who scores ≥ 19 will be considered a screen failure and excluded from the study.
Once the subject is enrolled, in the pre-operative holding area they will be asked to complete the Pain Catastrophizing Scale (PCS), the PROMIS® Emotional Distress-Depression - Short Form 8a, and the PROMIS® Item Bank v1.0 - Sleep- Disturbance - Short Form 8a prior to surgery. The subject will also conduct a baseline functionality test to assess mobility and strength in their leg. The functional recovery will be assessed by determining the patient ability to walk 100 feet, go up 5 steps and raise their leg on the day of surgery. Scores can be 0 (no ability to raise the leg), 1 (some ability to raise the leg), and 2 (complete ability to raise the leg). These assessments will take approximately 15 minutes to complete.
Once these assessments are completed, subjects will be equally randomized to the intervention group (nCAP Signal Relief Patch + standard of care) or control group (standard of care). Both the control group and intervention group will receive approved ERAS multimodal standard of care. Only the interventional group will receive an nCAP Signal Relief Patch. Randomization 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.
Subjects will undergo surgery using the approved ERAS anesthetic and post-operative pain management protocols.
After surgery, the subjects randomized to the intervention group will have the nCAP Signal Relief patch applied to their surgical dressing by a trained researcher in the immediate Post Anesthesia Care Unit (PACU). Subjects 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 nCAP Signal Relief Patch. The control group will not receive a patch but will receive the standard of care ERAS protocol. Subjects in the intervention group will be instructed to keep the nCAP Signal Relief Patch on their surgical dressing to avoid the risk for skin irritation.
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
- Triple (Participant, Care Provider, Investigator)
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
- •>18 years of age
- •Scheduled for elective primary unilateral hip or knee replacement
排除标准
- •Active clinical depression, anxiety or catastrophizing
- •Raw score >19 on PROMIS Emotional Distress - Anxiety - Short Form 8a
- •Active alcoholism (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)
- •Severe chronic pain condition that requires daily preoperative opioid dependence
- •Total surgery revision, bilateral hip or nee replacement, other procedures under the same anesthetic
结局指标
主要结局
Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement
时间窗: Day of surgery up to 30 days post-operative
The primary endpoint will be to prospectively investigate the efficacy of the nCAP Signal Relief Patch in reducing perioperative opioid requirement in opioid-naïve patients undergoing primary unilateral total hip or knee replacement surgery using currently SHY ERAS anesthesia protocol. This is reported in consumption of oral morphine mg equivalents (OME) from the day of surgery up to day 30 post-operative. Opioid requirement will be estimated following the placement of the patch.
次要结局
- Pre-operative Sleep Disturbance(Screening visit)
- Post-operative Change in Emotional Distress Related to Anxiety(Day of surgery up to 30 days post-operative)
- Average Score of Functionality at Baseline(Screening visit)
- Pre-operative Emotional Distress Related to Anxiety(Screening visit)
- Average Score of Functionality Post-Operative(Day of surgery up to 30 days post-operative)
- Post-operative Change in Emotional Distress Related to Depression(Day of surgery up to 30 days post-operative)
- Length of Hospital Stay(Day of surgery up to 30 days post-operative)
- Pre-operative Emotional Distress Related to Depression(Screening visit)
- Post-operative Change in Sleep Disturbance(Day of surgery up to 30 days post-operative)
- Pre-operative Pain Rating Using the Pain Catastrophizing Scale(Screening visit)
- Change in Post-operative Pain Rating Using the Pain Catastrophizing Scale(Day of surgery up to 30 days post-operative)
- Change in Post-operative Pain Using a Numerical Rating Scale(Days 1-30 post-operative)
研究者
Jacques E. Chelly
Professor of Anesthesiology and Perioperative Medicine and Orthopedic Surgery Director, Regional Anesthesiology Fellowship Program
University of Pittsburgh