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临床试验/NCT04615299
NCT04615299已完成不适用

Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care

Anesthesiology WSU/DMC-NorthStar2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2018年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Pain Score Visual Analog Scale (VAS) 6 Hours Post Surgery

研究概览

简要总结

The study hypothesis is that perioperative Auricular (battlefield) acupuncture for general surgery and urology cases undergoing general anesthesia will decrease opioid requirements, postoperative pain, the incidence of PONV, and the incidence of perioperative anxiety in comparison to simulated (placebo) perioperative battlefield acupuncture.

详细描述

INTRODUCTION:

Battlefield acupuncture is an auricular therapy that has been used for centuries, with roots tied to Eastern Asian medicine. Ease of application, low cost, and minimal side effects make battlefield acupuncture a perioperative modality that has been linked to decreased morbidity and mortality in patients undergoing surgical procedures and anesthesia (1). In the United States, there is pressure by the government and the medical community to decrease opioid use, especially in the perioperative time period. Opiate use due to postoperative pain, postoperative nausea and vomiting (PONV), perioperative anxiety have all been linked to an increased hospital stay, increased morbidity, and mortality, and ultimately higher healthcare costs (2). Anesthesia providers can be trained in the application of acupuncture in the perioperative time period. Through analysis of rates of postoperative opioid use, postoperative nausea and vomiting and perioperative anxiety, the efficacy, and utility of battlefield acupuncture will be realized as an effective adjunct to multimodal anesthesia care.

STUDY DESIGN AND METHODS:

This will be a prospective randomized study to compare auricular battlefield acupuncture to sham auricular battlefield acupuncture in patients undergoing general surgery and urology cases with general anesthesia. Participants in the study will be randomly assigned to either receive auricular battlefield acupuncture (treatment group) or simulated (placebo; control group) auricular battlefield acupuncture. Battlefield acupuncture needles will be utilized in the test arm and blunt needle pressing and covering with acupuncture stickers will be utilized in the control arm as a sham treatment. Location of needles and stickers will be placed according to 5 VA approved BFA auricular acupuncture points associated with PONV, pain, and anxiety respectively (Figure 1; 3). In both arms, the treatment ear will be covered after treatment so as to blind the patient. Both battlefield acupuncture and control groups will receive small band aids on the battlefield acupuncture needle sites. Both the evaluators for post procedure assessment along with the patient will be blinded in regards to what group they are in.

Inclusion Criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Sham acupuncture covers will be placed on control participants

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1- Patients with an American Society of Anesthesiologists (ASA) Physical Status classification of 1 to 4 2 - Patients aged between 18 and 100 scheduled to undergo scheduled suitable inpatient/outpatient cases under anesthesia.
  • 3 - Patients must be willing and fit to give written informed consent 4 - Inpatient stay required

排除标准

  • Coagulopathies
  • Patients with continuous epidural
  • Uncooperative patient
  • Psychiatric disorders and language deficiencies that may interfere with the assessment of pain
  • Insufficient understanding of the pain scoring system.
  • Outpatient stay

结局指标

主要结局

Pain Score Visual Analog Scale (VAS) 6 Hours Post Surgery

时间窗: 6 hours

Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

Postoperative Opioid Consumption

时间窗: 24 hours

Patient opioid consumption in the 24 hrs post surgery

Pain Score Visual Analog Scale (VAS) 12 Hours Post Surgery

时间窗: 12 hours

Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

Pain Score Visual Analog Scale (VAS) 18 Hours Post Surgery

时间窗: 18 hours

Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery

时间窗: 24 hours

Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest

次要结局

  • Patient Satisfaction(24 hours)
  • Occurrence of Postoperative Vomiting(24 hours)
  • Occurrence of Postoperative Nausea(24 hours)
  • Occurrence of Any Adverse Reactions(24 hours)
  • Occurrence of Postoperative Anxiety(24 hours)

研究者

发起方
Anesthesiology WSU/DMC-NorthStar
申办方类型
Other
责任方
Sponsor

研究点 (2)

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