Clinical trial NCT04615299: Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care
Official title: Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acupuncture, Ear
Lead sponsor: Anesthesiology WSU/DMC-NorthStar
Sponsor class: OTHER
Collaborators: name: John D. Dingell VA Medical Center
First posted: 2020-11-04
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Opioid Consumption
timeFrame: 24 hours
measure: Pain Score Visual Analog Scale (VAS) 6 Hours Post Surgery
timeFrame: 6 hours
measure: Pain Score Visual Analog Scale (VAS) 12 Hours Post Surgery
timeFrame: 12 hours
measure: Pain Score Visual Analog Scale (VAS) 18 Hours Post Surgery
timeFrame: 18 hours
measure: Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Occurrence of Postoperative Vomiting
timeFrame: 24 hours
measure: Occurrence of Postoperative Nausea
timeFrame: 24 hours
measure: Occurrence of Postoperative Anxiety
timeFrame: 24 hours
measure: Patient Satisfaction
timeFrame: 24 hours
measure: Occurrence of Any Adverse Reactions
timeFrame: 24 hours
Other outcomes:
Locations:
city: Detroit
country: United States
facility: John D. Dingell VA Medical Center
state: Michigan
Study officials:
affiliation: Wayne State University, John D. Dingell VA Medical Center
name: Padmavathi Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu Z, Dong H, Wang Q, Xiong L. Perioperative acupuncture modulation: more than anaesthesia. Br J Anaesth. 2015 Aug;115(2):183-93. doi: 10.1093/bja/aev227.
citation: Fleckenstein J, Baeumler PI, Gurschler C, Weissenbacher T, Simang M, Annecke T, Geisenberger T, Irnich D. Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial. Trials. 2014 Jul 21;15:292. doi: 10.1186/1745-6215-15-292.