Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care
Condition: Acupuncture, Ear
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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:

      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

      Exclusion Criteria:

        1. - Coagulopathies

        2. - Patients with continuous epidural

        3. - Uncooperative patient

        4. - Psychiatric disorders and language deficiencies that may interfere with the assessment
           of pain

        5. - Insufficient understanding of the pain scoring system.

        6. - Outpatient stay

      This study will be performed at the John D. Dingell VA Medical Center. Only a trained MD
      anesthesiologist will recruit patient in the preoperative period, where informed consent will
      be obtained. Computerized randomization will take place at the time the patient presents for
      surgery. Consent will be taken preoperatively.

      Anesthetic Plan:

      The anesthetic management will be general anesthesia with the provision of intravenous
      opioids intraoperatively and during recovery. Fentanyl will be the sole intra operative
      opioid. No other alterations of anesthetic management will take place pre or intra
      operatively. The battlefield acupuncture or sham battlefield acupuncture will be placed in
      the postoperative care unit (PACU).

      Acupuncture Plan:

      Typically acupuncture needles which are semi-permanent needles have the characteristics of
      remaining in the ear acupoints for up to 3-4 days before being pushed out toward to the
      surface by the previous flattened epidermis. The test arm (treatment group) will received
      actual acupuncture needles, while the control arm will received sham or placebo acupuncture
      via pressing of a blunt needle on the specified BFA locations and then application of
      adhesive stickers. In the control group simulating acupuncture, the needles will never enter
      the patients' skin and will give the impression to the patient that the procedure has taken
      place. The ear treated will be covered with a bandage via non-skin sensitive tape so as to
      blind the patient to which treatment group they are in.

      Statistical Analysis:

      An unpaired students-t-test procedure (two-sample assuming equal variances, two-tail
      significance p<0.05, 95% confidence interval) was performed to examine mean differences
      between the two study groups on all continuously scaled variables. A Repeated measures ANOVA
      will be used to measured differences between time for continuous variables at the 2 measured
      time points (1 hour and 24 hours). Assumptions of normality and/or homogeneity of variance
      will be checked and verified. Comparisons between study groups on proportional differences
      will be examined using a non-parametric Fisher's Exact Chi-square test, when applied to 2x2
      tables. Statistical significance will be set at a p-value ≤0.05. All continuous data will be
      expressed as the mean with 95% upper and lower confidence intervals or Mean ± Standard
      deviation.

      A binary outcome, superiority power analysis based on a rate of 33% reduction of opioid
      consumption in the auricular battlefield acupuncture group compared to controls (sham
      auricular battlefield acupuncture) concluded 72 participants (36 patients per group) would be
      necessary to achieve 80% power with a p<0.05.
    

Intervention name(s): Auricular acupuncture
Intervention type(s): Device
Intervention description(s): Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The treatment group (Group 1) will receive postoperative auricular battlefield acupuncture. The control group (Group 2) will receive sham (placebo) postoperative auricular battlefield acupuncture.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care