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JICM

JOURNAL OF INTEGRATIVE AND COMPLEMENTARY MEDICINE


Volume 28, Number 8, 2022, pp. 683–688
ª Mary Ann Liebert, Inc.
DOI: 10.1089/jicm.2021.0429

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ORIGINAL ARTICLE

Battlefield Acupuncture Use for Perioperative


Anesthesia in Veterans Affairs Surgical Patients:
A Single-Center Randomized Controlled Trial
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Mohanad Baldawi, MD,1 George McKelvey, PhD,1,2 Vijval R. Patel, MS,2 Brinda Krish, DO,1
Aashish Jay Kumar, MD,1 and Padmavathi Patel, MD1,2

Abstract
Introduction: The risks from opioid use are well known in and mandate nonpharmacological modalities for
the management of postoperative pain. The aim of this study was to investigate the effectiveness of battlefield
acupuncture (BFA) as an adjunct therapy for postoperative pain in U.S. veteran patients undergoing major sur-
gery under general anesthesia.
Methods: Patients undergoing major surgery performed under general anesthesia from June 2017 to June
2018 were enrolled in the study. Patients were randomly assigned to receive either BFA or sham acupuncture.
Outcomes such as pain intensity measured by visual analog scale score, opioid consumption, and the incidence
of analgesia-related adverse effects were compared between the study groups.
Results: A total of 72 subjects were included in this study (36 subjects in each study group). The median 24-h
opioid postoperative consumption measured in morphine milligram equivalent (MME) was lower in the BFA
group compared to the sham acupuncture group (18.3 [–12.2] MME vs. 38.6 [–15.9] MME, p < 0.001). Pain
intensity reported by patients at 6, 12, 18, and 24 h postoperatively was lower in the BFA group compared to the
sham acupuncture group. The incidence of postsurgical nausea and vomiting was lower in patients receiving
BFA compared to patients receiving sham acupuncture. There were no intergroup differences in terms of post-
operative anxiety or hospital length of stay.
Conclusion: The results from this study reveal the potential clinical benefits of using BFA for reducing pain
intensity and opioid requirements in surgical patients.

Keywords: acupuncture, pain management, opioid, randomized clinical trial, veterans

Introduction ditions, including low-back pain, cancer, and postoperative


pain.1,2 Auricular acupuncture includes different treatment
modalities, one of which is battlefield acupuncture (BFA).3
A uricular acupuncture is a traditional pain therapy
originating in Eastern Asia and has been reported to
be an effective adjunct in pain management of several con-
Opioid abuse is an epidemic ravaging community and the
U.S. health resources. The Center for Disease Control and

1
Department of Anesthesiology and Pain Services, Detroit Medical Center, Detroit, Michigan, USA.
2
Department of Surgical Services, John D. Dingell VA Medical Center, Detroit, Michigan, USA.
Disclosure: This article was accepted for oral presentation in the 2022 International Congress on Integrative Medicine
and Health.

683
684 BALDAWI ET AL.

Prevention (CDC) estimates there are more than 1000 emer- recovery. Fentanyl was the only intraoperative opioid used. All
gency room visits and 91 deaths related to opioid misuse patients were admitted to the postanesthetic care unit follow-
every day.4 Health care practices have been implicated as ing surgery where they received BFA or sham acupuncture.
causative factors in this epidemic with poorly defined post-
operative pain treatment resulting in many patients receiving
Acupuncture technique
larger opioid prescriptions than needed. Resolving this issue
requires a collaborative effort, including curbing the exces- After disinfection of the patient’s ear, a 2 mm stainless
sive prescription of opioids by surgical providers, while man- steel needle (Aiguille d’acupuncture Semi-Permanente ASP
aging postsurgical pain appropriately. gold, France) was implanted in patient ear using the needle
This study aimed to determine whether BFA is associated plastic injector. The needle was implanted on the same side
with decreased opioid requirements, perioperative pain, and as patient surgical field or in the patient’s right ear in case of
perioperative analgesia-related adverse effects in U.S. vet- midline surgical field. The correct needling was confirmed
erans undergoing major surgery under general anesthesia. by a characteristic click at the time of insertion, and no other
This study was approved by the Institutional Review needle stimulation was required. The needles spontaneously
Board of the John D. Dingell VA Medical Center, Detroit, fell out after 3–4 days postoperatively.
Michigan. In the sham acupuncture group, a blunt needle was used
to superficially penetrate the patient’s ear and then removed
immediately. BFA and sham needles were placed in five
Materials and Methods auricular acupuncture points, which are linked with pain
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relief: Omega 2, Shen Men, Point Zero, Hypothalamus, and


Study design
Cingulate Gyrus5 (Fig. 1). The treated auricular points were
This double-blinded randomized clinical trial is regis- covered with skin nonsensitive tape to ensure successful
tered on ClinicalTrials.gov (Clinical Trial Registration no. blinding.
NCT04615299). Patients undergoing a surgical procedure
under general anesthesia from June 2017 to June 2018 were
Measured outcomes
screened for enrollment in the study.
Patients (n = 72) were randomly allocated using a The primary outcomes were pain visual analog scale
blocked randomization list into two equal groups (n = 36 (VAS) score and opioid requirement in morphine milligram
per group; block sizes 4 and 8) to either receive BFA or equivalent (MME) in the first 24 h following surgery. VAS
sham acupuncture. Blocked random sequence generation score is used in epidemiologic and clinical research to mea-
was obtained using an online randomizer (Sealed Envelope sure the intensity of pain.6 MME is the unit of measurement
Ltd. 2021. Create a blocked randomization list. Online of opioid intake widely used in clinical practice when pre-
document at: https://www.sealedenvelope.com/simple- scribing different opioid medications.7
randomiser/v1/lists). For treatment allocation, the physi- The secondary endpoints were postoperative length of stay,
cian placing the BFA or sham needles performed the ap- postoperative nausea and vomiting, and any other adverse
propriate treatment regimen based on the random effect reported within 24 h following surgery, including
generated treatment allocations assigned within individual acupuncture site infection, acupuncture site bleeding, aller-
sealed opaque envelopes. gic reaction to acupuncture needles, and scar tissue forma-
The physician placing the BFA or sham acupuncture tion at the site of acupuncture placement. Patient satisfaction
was not involved in assessing or treating the patients for with postoperative analgesia was estimated using a 10-point
any study measure or outcome. Patients receiving treat- scale.
ment were blinded to treatment allocation. All health care
practitioners providing study-related treatments and evalu-
Statistical analysis
ating study outcomes were blinded to treatment allocation.
All eligible subjects received an educational session on the Power calculations for continuous outcome for a superi-
theory of BFA, and written informed consent was obtained ority trial were based on a detection of 33% difference in
from participants before surgery. opioid consumption, a decrease in the primary outcome mea-
Patients were deemed eligible to participate in the study sure from 30 MME in the control group to 20 MME in the
if they were: (1) 18–100 years old, (2) undergoing major sur- experimental group with a standard deviation of 15 MME
gical procedure, (3) required to stay in hospital for at least between study groups (https://www.sealedenvelope.com/
24 h postoperatively, and (4) able and willing to give infor- power/continuous-superiority/). This analysis concluded that
med consent. Major surgery was defined as any extensive a minimum of 36 participants in each group were necessary
procedure requiring general anesthesia and overnight or to produce 80% statistical power. A 33% reduction in opioid
extended hospital stay. These included bowel cavity oper- consumption with a standard deviation of 15 MME repre-
ations, vascular surgeries, and joint reconstructive surgeries. senting a moderate standard mean difference of 0.5 compa-
Patients were excluded from the trial if they have: (1) his- red to controls was based on a meta-analysis where auricular
tory of bleeding or coagulopathy disorder, (2) history of therapy was observed to reduce analgesic use (standard
psychiatric or neuropathic disorder, which might interfere mean difference, 0.54 [95% confidence interval: 0.30, 0.77];
with pain assessment, and (3) continuous epidural anesthetic 5 studies).8
treatment following surgery. Differences between groups were considered statically
The anesthetic management was general anesthesia with significant when a p-value was <0.05 (2-sided). Normally
provision of intravenous opioids intraoperatively and during distributed continuous data were analyzed using two
BATTLEFIELD ACUPUNCTURE IN VETERANS AFFAIRS SURGICAL PATIENTS 685

FIG. 1. Niemtzow’s BFA points. BFA,


battlefield acupuncture.
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independent samples t-test and presented in mean – standard surgeries, including video-assisted thoracoscopic surgery and
deviation, while nonparametric continuous data were analyzed lung resection (n = 3), and vascular surgeries, including carotid
using Mann–Whitney U test and presented in median – endarterectomy and lower extremity angioplasty (n = 3).
interquartile range. Chi-square test was used to analyze In the randomization process, 36 patients were assigned
categorical data. Statistical analysis was conducted using to receive BFA, and same number of patients was assigned
STATA software. to receive sham acupuncture. Figure 2 demonstrates the
patient enrollment process. Table 1 summarizes patient
characteristics in the study groups.
Results
Patient characteristics Primary outcomes
Seventy-two* patients met inclusion criteria and were Subjects receiving BFA had lower average MME at
enrolled in the study. The majority of patients underwent 24 h postoperatively compared to subjects receiving sham
abdominal surgeries, including total and partial colectomy, acupuncture (18.3 [–12.2] vs. 38.6 [–15.9], p < 0.001). In
open and laparoscopic hernia repair, and laparoscopic cho- comparison to sham acupuncture group, pain intensity was
lecystectomy (n = 26), and the others underwent urinary tract significantly lower in BFA group at 6, 12, 18, and 24 h fol-
surgeries, including open and laparoscopic prostatectomy lowing surgery (Table 2). Study groups had similar VAS
and nephrectomy (n = 21), orthopedic surgeries, including total score in the preoperative period.
hip and total knee replacement surgeries (n = 19), thoracic
Secondary outcomes
*Correction added on May 18, 2022 after first online publi-
On a 10-point scale, patients receiving BFA reported higher
cation of May 6, 2022: The total number of patients was
satisfaction compared to patients receiving sham acupuncture
mistakenly listed as seventy-five. It has been corrected to se-
(Table 3). Patients receiving BFA had lower incidence of
venty-two to reflect the total number of patients listed in the
nausea and vomiting compared to patients receiving sham
subsequent breakdown by the authors.
acupuncture. There were no significant differences between
686 BALDAWI ET AL.

FIG. 2. Flow diagram


showing patient randomization
and allocation processes.
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study groups in the incidence of anxiety. All patients were Discussion


observed to have covering tape over acupuncture or sham Auricular acupuncture originated in Eastern Asia and has
acupuncture areas intact at the 24 h postoperative period. been used in the treatment of pain of different origins. In this
No acupuncture-related adverse effect was reported in the study, BFA was used as an adjunct anesthetic modality on
BFA or sham acupuncture groups. U.S. veteran patients undergoing major surgical procedures
under general anesthesia. The results revealed that patients
receiving BFA had reduced 0–24-h postoperative pain and
Table 1. Patient Characteristics and Type decreased opioid requirements compared to patients receiv-
of Surgery for Study Groups ing sham acupuncture. In addition, there were lower nausea
and vomiting rates and higher overall satisfaction for post-
BFA Sham
operative analgesia in patients receiving BFA.
Patient (n = 36); acupuncture
characteristics n (%) (n = 36); n (%) Opioid abuse has reached an epidemic level in U.S.
Mortality from drug overdose in the United States, mostly
Gender from opioid overdose, has more than tripled from 1999 to
Female 3 (8.3) 2 (5.5) 2015, and comprised 25% of drug overdose-related deaths
Male 33 (91.7) 34 (94.4) worldwide.9 In 2015, the CDC estimated that 91 individuals
Age, mean (–SD) 64 (–13.6) 64.2 (–9.4) died each day from opioid overdose in the United States.10
BMI, mean (–SD) 30.1 (–6.1) 28.8 (–5.9) This epidemic has placed an enormous burden on the U.S.
Race health care system as providers treat *1000 patients with
African American 13 (36.1) 18 (50) opioid overdose daily.4
White 18 (50) 12 (33.3) Recent evidence from the VA facilities scrutinized the new
Hispanic 1 (2.8) 0 prescribing guidelines for postoperative pain management,
Others 4 (11.1) 6 (16.7)
ASA class Table 2. Comparison Between Study Groups
Class I 1 (2.8) 0
for Pain Visual Analog Scale Score
Class II 2 (5.6) 2 (5.6)
Class III 32 (88.9) 33 (91.7) BFA; Sham
Class IV 1 (2.8) 1 (2.8) Postoperative mean acupuncture;
Type of surgery time (–SD) mean (–SD) p
Abdominal surgery 10 (27.8) 16 (44.4)
Urinary tract surgery 7 (19.4) 14 (38.9) Presurgery 4.8 (–2.6) 5.4 0.2
Orthopedic surgery 17 (47.2) 2 (5.6) 6h 4.3 (–1.9) 6.8 (–1.9) <0.001
Thoracic surgery 1 (3.3) 2 (5.6) 12 h 3.6 (–1.7) 6.4 (–1.6) <0.001
Vascular surgery 1 (3.3) 2 (5.6) 18 h 3.1 (–1.5) 5.6 (–1.6) <0.001
24 h 2.3 (–1.4) 5.3 (–2) <0.001
ASA, American Society of Anesthesiologists; BFA, battlefield
acupuncture; BMI, body mass index; SD, standard deviation. BFA, battlefield acupuncture; SD, standard deviation.
BATTLEFIELD ACUPUNCTURE IN VETERANS AFFAIRS SURGICAL PATIENTS 687

Table 3. Comparison Between Study Groups Limitations


for Secondary Outcomes
A major limitation to this study was the lack of homo-
BFA Sham geneity of patient surgery type between treatment groups,
(n = 36); acupuncture which was due to the small number of subjects undergoing
Outcome n (%) (n = 36); n (%) p individual procedures. This imbalance in specific surgical
populations between study groups may ‘‘muddy’’ the speci-
Patient analgesia 7.1 (–1.2) 6.1 (–1.7) 0.003 fic benefits of BFA observed in this study. To address this
satisfaction, limitation, further BFA studies using larger sized groups of
mean (–SD)
Total hospital stay 3.5 (–3.2) 4.8 (–8.7) 0.42 more homogenous surgical populations are required. Studies
in day, such as these may determine if the analgesic effectiveness
mean (–SD) of BFA observed in this study can be replicated across spe-
Nausea 1 (2.8%) 13 (36.1%) 0.0004 cific surgical populations.
Vomiting 0 11 (30.6) 0.0003 Clinical staff providing treatment to the study patients
Anxiety 4 (11.1%) 5 (13.9%) 0.72 were blinded to the patients’ group allocation due to the
study blinding method of covering the study patients’ ears
BFA, battlefield acupuncture; SD, standard deviation.
with adhesive tape. However, an intrinsic limitation of this
study is the potential difference in the clinical staff assess-
ment (assessment of VAS score) and treatment (adminis-
which started in response to IV opioid shortage.11 It demon- tering rescue opioid medications) of study patients.
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strated a significant decrease in severe pain score, although


there was a similar decrease in IV opioid prescriptions fol- Conclusions
lowing implementation of the new guidelines. Previous studies
reported increased risk of opioid dependency in patients re- In conclusion, the diminished postoperative pain inten-
ceiving postoperative opioid prescriptions. sity, reduced postoperative opioid requirement, and the lower
Multiple population-based studies of opioid-naive pa- incidence of postoperative nausea and vomiting observed in
tients undergoing surgery found that patients receiving surgical patients receiving BFA demonstrate the potential
opioid prescriptions were at high risk for chronic opioid use advantages of this low-cost and low-risk therapy in this
following surgery.12,13 A review of 1.3 million opioid-naive patient population. Further research is needed to test the
patients found that the rate of opioid use at 1 year postoper- effectiveness of BFA in individual surgical procedures.
atively was 6% in patients receiving 1-day opioid prescrip-
tions following surgery, and 13.5% in patients receiving Authors’ Contributions
prescriptions for more than 7 days postoperatively.14 All authors certify that they have participated sufficiently
The implications of acupuncture for the management of in this work, including participation in the concept, design,
postoperative pain, opioid requirement, and nausea and vom- analysis, or writing of the article, and take responsibility for
iting have been studied in previous publications. Acupunc- the content of the article.
ture analgesic mechanisms are not fully understood; however,
multiple scientific studies suggested different theories, includ- Author Disclosure Statement
ing release of endogenous opiate peptides, activation of the
pain-related neuromatrix, and modulation of the hypothalamic- No competing financial interests exist.
limbic system in human brain.15–17 Previous meta-analyses
and randomized clinical trials concluded that auricular ther- Funding Information
apy is effective in reducing pain and opioid requirement,18–30 No funding was received for this article.
while other clinical trials found no significant difference
between auricular therapy and control groups.31–36
Supplementary Material
The difference in outcomes in studies that have shown
no benefit from acupuncture use may be attributed to dif- Supplementary Table S1
ferences in smaller sample sizes.35 Other studies that ob-
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application of auricular acupuncture for the treatment of E-mail: mohanad.baldawi90@gmail.com

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