1 USE OF DISPOSABLE ACUPRESSURE DEVICE AS PART OF A

USE OF DISPOSABLE ACUPRESSURE DEVICE AS PART OF A MULTI-MODAL ANTIEMETIC
STRATEGY FOR REDUCING POSTOPERATIVE NAUSEA AND VOMITING
Paul F. White, Ph.D., M.D., F.A.N.Z.C.A.*, Manxu Zhao, M.D.**, Jun Tang, M.D.†, Ronald H. Wender,
M.D.††, Roya Yumul, M.D., Ph.D.††, Alejandro V.S. Sloninsky, M.D.††, Robert Naruse, M.D.††, Robert
Kariger, M.D.††, Scott Cunneen, M.D.‡
*
Director of Clinical Research, Department of Anesthesiology at Cedars-Sinai Medical Center in Los
Angeles; Visiting Scientist at Instituto Ortopedico Rizzoli, University of Bologna, IT
**
Resident, Department of Anesthesiology, Cedars-Sinai Medical Center, Los Angeles, CA
†
Clinical Research Fellow, Department of Anesthesiology, Cedars-Sinai Medical Center, Los
Angeles, CA
††
Staff Anesthesiologist, Department of Anesthesiology, Cedars-Sinai Medical Center, Los Angeles,
CA
‡
Director of Bariatric Surgery, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles,
CA
Address correspondence to:
Dr. Paul F. White, President, White Mountain Institute, 144 Ashby Lane, Los Altos, CA 94022
E-mail: [email protected] and [email protected]
Short title: Use of acupressure as part of a multimodal prophylactic antiemetic regimen
Financial support: The active and sham Pressure Right® acupressure devices were provided by
Therapeutics: 101 Inc. Dr. White receives support from the White Mountain Institute, a private non-for-profit
education and research foundation.
.
1
ABSTRACT
Background: Controversy still exists regarding the optimal strategy for managing postoperative nausea
and vomiting (PONV) in high-risk surgical populations. Although acustimulation at the P6 acupoint has
been demonstrated to be effective in preventing PONV, the effect of this non-pharmacologic therapy on the
patient‟s recovery of quality of life and resumption of normal activities has not been previously assessed
when it is used as part of a multi-modal antiemetic regimen after major laparoscopic surgery. Therefore, we
designed this randomized, sham-controlled, and double-blinded study to assess the efficacy of a
disposable acupressure device (Pressure Right®) on the incidence of PONV and quality of recovery when
used in combination with ondansetron and dexamethasone for antiemetic prophylaxis.
Methods: Following IRB-approval, 100 consenting ASA I-III patients undergoing major laparoscopic
procedures were randomly assigned to either a Control group (n=50) receiving a “sham” acustimulation
device or a Acupressure group (n=50) receiving a disposable Pressure Right® device placed at the P6
point bilaterally at least 30 min prior to induction of anesthesia. All patients received a standardized general
anesthetic technique consisting of propofol (2-2.5 mg/kg), fentanyl (1.5-2.5 ug/kg), desflurane (3-6% ET),
ketorolac (30 mg IV) and local anesthesia (bupivacaine 0.25%) at the incision sites to minimize
postoperative pain. A combination of ondansetron, 4 mg IV, and dexamethasone, 4 mg IV, was
administered during surgery for antiemetic prophylaxis in both study groups. The incidence of nausea and
vomiting and the need for „rescue‟ antiemetic therapy were assessed at specific time intervals for up to 72 h
after surgery. The recovery profiles and quality of recovery questionnaires were evaluated at 48 h, 72 h,
and 30 d after surgery. Patient satisfaction with their PONV management was assessed at 72 h using a
three-point verbal rating scale (1= dissatisfied, 2= satisfied, and 3= highly satisfied).
Results: The two study groups did not differ with respect to their demographic characteristics or risk
factors for PONV. The incidence of vomiting was significantly decreased in the Acupressure group. Use of
the acupressure device also significantly enhanced patient satisfaction with their PONV management and
quality of recovery at 48 h after surgery. However, the recovery times to hospital discharge, resumption of
normal physical activities, and return to work did not differ significantly between the two study groups.
Conclusion: Use of the Pressure Right® acupressure device in combination with antiemetic drugs was
more effective than antiemetic drugs alone in reducing emetic symptoms, as well as improving patient
satisfaction with their PONV management and quality of recovery after laparoscopic surgery procedures.
2
INTRODUCTION
Postoperative nausea and vomiting (PONV) is a long-standing problem for anesthesia practitioners
(1). Patient, anesthetic and surgical factors can all contribute to the persistently high incidence of emetic
symptoms in the postoperative period. Despite the introduction of many new antiemetics, routine use of
prophylactic antiemetic drugs and the availability of practice guidelines, the incidence of PONV remains
high in „at risk‟ patients undergoing ambulatory surgery (2). According to a recently published review article
(3), PONV is the most common complaint following surgery, with an overall incidence of 30% after elective
operations and up to 70-80% in high-risk populations in the absence of antiemetic prophylaxis. The issue of
post-discharge nausea and vomiting (PDNV) has become particularly important for the growing outpatient
population undergoing ambulatory and office-based surgical procedures because they may not have ready
access to „rescue‟ antiemetic therapies after discharge home (4,5).
Previous clinical studies have demonstrated that the use of a combination of prophylactic antiemetic
therapies (6,7), so-called multimodal antiemetic therapy, reduce the incidence of PONV and PDNV while
improving patients‟ satisfaction with their quality of recovery and may facilitate a more rapid resumption of
normal activities of daily living. Although low-dose droperidol is a highly-effective antiemetic for routine
prophylaxis (8), concern regarding the FDA-imposed Black Box warning has severely limited its clinical use
(9). Since both ondansetron and dexamethasone possess similar antiemetic efficacy to droperidol when
administered for routine prophylaxis (10), these two drugs have become increasingly popular for antiemetic
prophylaxis in the ambulatory and office-based surgical setting (3, 9, 11, 12).
Previous studies with various types of non-invasive acustimulation devices (e.g., simple
acupressure and transcutaneous acupoint electrical stimulation [TAES]) are effective in reducing PONV
when applied at the P-6 acupoint without drug-related side effects (13-15). In an earlier study, we
demonstrated that the combination of ondansetron and transcutaneous electro-acustimulation was more
effective than ondansetron alone in preventing PONV (16). These preliminary findings were subsequently
confirmed by Gan et. al. (17) who further suggested that acustimulation could also produce analgesic
effects.
Therefore, we designed a sham-controlled study to evaluate the antiemetic efficacy of a disposable
acupressure device (Pressure Right® [Fig. 1], Pressure Point Inc., Grand Rapids, MI.) as part of a
multimodal regimen for preventing PONV in patients undergoing laparoscopic surgery procedures. The
primary objective of this preliminary study was to test the hypothesis that the use of the Pressure Right
3
device in combination with the most commonly used multi-drug prophylactic antiemetic regimen, namely
ondansetron and dexamethasone, would result in a lower incidence of postoperative vomiting (emesis)
compared to the drug combination alone. The secondary objectives of the study were to assess the effect
of this multi-modal combination therapy on the need for rescue antiemetic drugs, patient satisfaction and
quality of recovery, as well as times to resumption of their normal activities of daily living.
4
METHODS
After obtaining IRB approval, 100 consenting patients scheduled to undergo laparoscopic (e.g.,
cholecystectomy, bariatric gastric [bypass] surgery) surgical procedures participated in this prospective,
randomized, double-blinded study. The study patients received either a “sham” strip (Control group) or
Pressure Right® strip (Acupressure group) according to a computer generated randomization scheme. The
strips appeared to be identical following placement by a co-investigator who was not involved in the
evaluation of the patient during the perioperative period. Patients who had received any antiemetic drugs
within the preceding 24 h, those who had previous experience using an acustimulation technique (i.e.,
acupuncture, acupressure or TAES) for either management of pain or emetic symptoms, a history of
alcohol or drug abuse within the last 3 months, or a skin lesion or irritation at the P-6 acupoints were
excluded from participating in this study.
In the preoperative holding area, 30-60 min before entering the operating room, a “sham” strip or a
Pressure Right® strip was placed at the P6 point bilaterally. Patients were instructed to leave the strips in
place for 72 hours after their operation. All patients were premedicated with midazolam, 20 µg/kg IV,
approximately 5 min prior to entering the operating room. General anesthesia was induced with IV propofol,
2-2.5 mg/kg, and fentanyl, 0.75-1.5 ug/kg IV. Cisatracurium, 0.2-0.4 mg/kg IV, or rocuronium, 0.6-1.2
mg/kg IV, was used to facilitate tracheal intubation and insertion of the laparoscopic instruments.
Immediately prior to the start of surgery, dexamethasone (4 mg IV), was administered to all patients.
Maintenance of anesthesia consisted of desflurane 3–6% end-tidal concentration in an air/oxygen mixture.
In addition, intermittent bolus doses of fentanyl, 50 µg IV, were administered as needed for intraoperative
analgesia. Ondansetron, 4 mg IV, was administered at the end of surgery upon withdrawal of the
laparoscope. Upon completion of the operation (i.e., skin closure), residual neuromuscular block was
reversed with neostigmine, 2.5–5 mg, and glycopyrrolate, 0.3–0.6 mg IV, and the maintenance anesthetic
(desflurane) was discontinued. All patients received 15-25 ml/kg of IV fluids during the perioperative period.
Emergence times were determined at 1 min intervals from discontinuation of the volatile anesthetic
to awakening (i.e., opening eyes on verbal command) and orientation (i.e., correctly stating their name, date
of birth, and the hospital). The times to post-anesthesia care unit (PACU) discharge were assessed at 10min intervals according to the modified Aldrete criteria (18). The incidences of patient complaints of nausea,
5
or vomiting (or retching), drowsiness, and restlessness, were recorded prior to discharge from the PACU at
the ambulatory center, and at 24, 48, and 72 h intervals postoperatively by a blinded observer (JT) who
directly questioned each patient prior to discharge and via telephone interviews about the occurrence of
PONV symptoms and any other postoperative side effects. PONV symptoms and side effects were
recorded as binary categorical responses (i.e., presence or absence). The need for any rescue antiemetic
medication during the postoperative follow-up intervals was also noted. Rescue medication in the predischarge period consisted of metoclopramide, 10 mg IV, and prochlorperazine, 25 mg supp, was
prescribed to treat post-discharge emetic symptoms. A “complete response” to the prophylactic antiemetic
treatment regimen was defined as the absence of any emesis (or retching) and no need for antiemetic
rescue medication during the entire 72 h study period. “Complete control” of emetic symptoms after surgery
was defined as the absence of any nausea, no episodes of vomiting/retching, and no requirement for
rescue antiemetic therapy during the 72 h postoperative study period (2).
.
Patient satisfaction with their PONV management was assessed at 72 h using a three-point verbal
rating scale (1= dissatisfied, 2= satisfied, and 3= highly satisfied). The patient‟s quality of recovery (QoR)
score was assessed using a standardized nine-item questionnaire at 48 h and 72 h after surgery (19). The
ability to tolerate normal dietary intake, return of normal bowel function, and to resume the normal activities
of daily living (e.g., return to work) after surgery were queried at the 24 h, 48 h, 72 h, and 30 d follow-up
evaluations and the recovery times (in days) were recorded by the blinded interviewer. The definition of
„constipation‟ was as follows: (1) bowel movements occur less often than usual, (2) no bowel movement in
the first three days after surgery, or (3) unusually hard stools that were painful or difficult to pass.
Statistical Analysis:
A power analysis ( = 0.05, β = 80%) was performed before the initiation of the study using the
software nQuery Advisor
TM
(version 1.0, Janet D. Elashoff, 1995). This analysis suggested that group sizes
of >45 should be adequate to detect a 50% decrease in the number of patients experiencing emetic
symptoms in the acupressure + antiemetic drug treatment (Acupressure) group compared to antiemetic
drugs alone („sham‟ Control group) assuming a 40% incidence in these „at risk‟ surgical patients undergoing
major laparoscopic procedures (2, 6,7). The Student‟s t-test was used to analyze the parametric data,
2
test or Fisher‟s exact test was used to analyze the nonparametric data. A p-value <0.05 was considered
statistically significant.
6
RESULTS
A total of 100 patients completed the study and all participants completed the follow-up
evaluations. Demographic characteristics, including age, body weight, smoking status, and histories of
PONV or motion sickness were comparable in both antiemetic study groups (Table 1). In addition, there
were no differences in the type of laparoscopic surgery procedures, the duration of anesthesia and surgery,
or in the dosages of preoperative medication, induction and maintenance anesthetics, neuromuscular
relaxant and reversal drugs. Importantly, there were no differences in the use of intraoperative (Table 1)
and postoperative (Table 2) opioid analgesic medications in the two study groups.
The incidence of postoperative vomiting (emesis) was significantly reduced in the Acupressure (vs.
„sham‟ Control group) from 0-24 h and from 0-72 h (Table 3). However, the need for rescue antiemetic was
non-significantly reduced at 24 h, 48 h and 72 h after surgery. With respect to the early recovery profiles
and discharge times (Table 2), there were no significant differences between the two treatment groups.
Late recovery times (e.g., time to resumption of physical activities and to return to work) failed to achieve a
statistically-significant difference between the two treatment groups (Table 2). Compared to the Control
group receiving antiemetics alone, the „complete response‟ and „complete control‟ rates were nonsignificantly higher in the Pressure Right® group (72% vs. 54% [p=0.06] and 54% vs. 42% [p=0.23],
respectively) (Table 3).
Finally, use of the Pressure Right® device as an adjunct to standard antiemetic therapy also
significantly enhanced patient satisfaction with their PONV management and their quality of recovery
scores at 48 h after surgery (Table 2). However, the incidences of postoperative side effects did not differ
between the two study groups (Table 4).
7
DISCUSSION
Recent studies (2-5) have demonstrated that despite the administration of multimodal antiemetic
drug prophylaxis, patients „at risk‟ to PONV continue to experience an unacceptably high incidence of
PONV symptoms which interfere with their recovery after ambulatory surgery. For example, in
outpatients undergoing major laparoscopic and plastic surgery procedures, over 40% of these patients
reported that nausea and/or vomiting interfered with their postoperative functioning during the first 72 h
after surgery (2) despite receiving prophylactic antiemetic therapy according to the PONV guidelines
published by the Society for Ambulatory Anesthesia (SAMBA).(9)
Acustimulation has been reported to produce sedation, reduce preoperative anxiety levels, and
decrease the severity of postoperative pain, nausea and vomiting in the ambulatory setting (20). A
variety of acustimulation techniques have been used to control emetic symptoms in the postoperative
period, including acupressure (13,21), acupuncture (22,23), and transcutaneous electrical stimulation
(14,16,17).
A recent systematic review of P-6 acupoint stimulation (vs. sham or non-acupoint
treatments) for PONV reported that acustimulation reduced nausea, vomiting and the need for „rescue‟
antiemetic therapy after surgery (24). Furthermore, these investigators and others (25) have concluded
that there was no difference in the efficacy of invasive (e.g., acupuncture) and non-invasive (e.g.,
acupressure, TAES) acustimulation techniques for preventing emetic symptoms after surgery. However,
the timing (pre- versus postoperative) of the acupoint stimulation is important in achieving an optimal
benefit. Acupressure is clearly more effective when administered in the postoperative period (26).
Although some acustimulation studies (14,17,27) have suggested that these techniques are more
effective in reducing nausea than vomiting (or retching), the current study demonstrated greater efficacy
in reducing emetic symptoms. The failure to demonstrate a statistically-significant effect on postoperative
nausea (and the incidence of „complete control‟), may have been related to the insensitive method used
to assess postoperative nausea (i.e., a binary [Yes or No] response) rather than the more conventional
11-point verbal analog scale (0=none to 10= intolerable) or a 4-point descriptive scale (e.g., 0=none,
1=mild, 2=moderate, or 3= severe).
Acustimulation appears to be comparable to the popular 5-HT3 antagonist, ondansetron, in the
prevention of PONV (16,17). Given the importance of a multimodal approach to controlling the
uncomfortable symptoms of PONV (28), we felt it was important to evaluate the use of this simple, noninvasive, disposable acupressure device as part of a standard multimodal antiemetic regimen in order to
8
determine if it would prove „added value‟ to the standard antiemetic drug regimen in everyday clinical
practice. The Pressure Right® pressure-sensitive adhesive wrist strip is an all-medical grade
acupressure device that does not extend completely around the entire circumference of the wrist to
avoid a „tourniquet effect‟ that might result in ischemia in the hand (Fig. 1). The adhesive material which
holds the band in place is porous and breathable and the backing material is a hypoallergenic
polyacrylate adhesive (Transpore® tape, 3M Corp. Minneapolis, MN) which has no dry rubber or natural
rubber latex and the maximum adhesion is achieved at 6 h after application and remains stable for 48 h.
With the exception of the Sea Band® and Relief Band®, none of the other commerciallyavailable acustimulation devices (Table 5) have undergone clinical testing to establish their efficacy in
preventing PONV and PDNV. The most extensively investigated acustimulation device is the Relief
Band® device which has the appearance of a plastic wristwatch with an elastic adjustable velcro band
(14,16,17,26). The TAES device is worn on the ventral (palmar) aspect of the wrist and transcutaneous
stimulates the P-6 acupoint using a low level, variable-intensity electrical current. In addition to
undergoing mechanical (bench) testing to demonstrate that an acupressure device can maintain a
pressure of 5-7 PSI at the P-6 acupoint, the FDA requires evidence of clinical efficacy in shamcontrolled studies before new acupressure devices are approved for marketing. It was also necessary to
demonstrate that the Pressure Right® device remains on a person‟s wrist for at least 24 h without
separation of the pressure bead on the adhesive wrist strip from the skin. All of the patients in the
current study reported that the Pressure Right® (and sham) strips remained in place for at least 24 h
and in 88% of the study patients, the device remained in place for the entire 72 h study period (even
though more than half of the patients participating in this study were either obese or morbidly obese).
This observation was important because of the need for more effective antiemetic therapies in the postdischarge period (5). There is a clear need for additional studies evaluating risk factors for PDNV and
the impact of current pharmacologic and non-pharmacologic therapies (29).
The issue of PDNV remains a concern for practitioners because of the continuing growth in the
number of ambulatory, office-based and short-stay surgical procedures. It has been reported that onethird of the patients undergoing ambulatory surgery continue to experience emetic symptoms after
returning home, and that the prophylactic treatment of this complication would ideally extend well
beyond the time of discharge from the hospital (2-5). The current options for achieving antiemetic
efficacy in the post-discharge period include drugs which are either extremely expensive (e.g.,
9
aprepitant [Emend®], palonesetron [Aloxi®]) or have potential long-lasting side effects (e.g.,
transdermal scopolamine) (30). Therefore, an inexpensive non-pharmacologic approach involving
acustimulation (Table 5) could be a highly cost-effective adjuvant to the currently used antiemetic drug
regimens (e.g., droperidol, ondansetron, dexamethasone).
In conclusion, this preliminary „sham‟-controlled study demonstrated that the adjunctive use of the
disposable, non-invasive Pressure Right® acupressure device enhanced the efficacy of the most
commonly used prophylactic antiemetic drug combination. Further studies are needed to determine the
cost-benefit of using this disposable acupressure device for routine antiemetic prophylaxis in the
ambulatory setting.
10
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13
Table 1: Patient Demographic, Anesthesia Characteristics and Preoperative Nausea Score in the Two
Study Groups†
Control (‘Sham)
Pressure Right®
50
50
Age (yr)
4311
4614
Gender (M/F) (n)
17/33
22/28
Weight (kg)
9731
9026
Height (cm)
1658
16910
History of PONV [n (%)]
6 (12)
4 (8)
History of motion sickness [n (%)]
13 (26)
14 (28)
Number (n)
Active tobacco user (smoker) [n(%)]
9(18)
6 (12%)
Laparoscopic surgery (n)
Cholecystectomy
24
21
Gastric bypass
26
29
Preoperative nausea (0-10)
0 (0-0)
0 (0-0)
Anesthesia time (min)
13534
13748
Surgery time (min)
11229
11544
Propofol (mg)
22068
22893
Fentanyl (g)
19967
20473
4±1
4±1
Desflurane (ave. ET %)
† Values are means ± SD, median (interquartile range), numbers (n), and percentages (%)
PONV=Postoperative nausea and vomiting
No significant differences were found between the two study groups
14
Table 2: Recovery Profiles and the Analgesic Requirements in the Two Study Groups†
Control (‘Sham’)
Pressure Right®
Extubation time (min)
7±3
6±2
Following commands (min)
8±3
8±3
Orientation (min)
9±3
9±2
12662
13653
Tolerate oral intake (h)
18±3
19±4
Discharge home (d)
2±1
2±1
In PACU
1.2±1
1.1±1
After PACU discharge
2.5±2
2.7±3
Time to normal solid food (d)
88
87
Resumption of physical activities (d)
128
117
Returned to work (d)
1512
1513
48 h quality of recovery score (0-18)
16 (15-18)
17 (16-18)*
72 h quality of recovery score (0-18)
17 (16-18)
17 (16-18)
Duration of PACU stay (min)
Hydromorphone (mg)
† Values are means ± SD, and medians (inter-quartile ranges)
PACU=Post-anesthesia care unit
* P < 0.05 vs. Control (Sham) group
15
Table 3: The Overall Incidence of Postoperative Nausea and Vomiting (PONV), as well as
the need for „Rescue‟ Antiemetic Medication in the Two Study Groups†
Control
Pressure Right®
(‘Sham’)
Number (n)
50
50
Nausea‡
24 (48)
20 (40)
Vomiting
13 (26)
5 (10)*
Rescue antiemetic
22 (44)
14 (28)
Nausea‡
8 (16)
4 (8)
Vomiting
5 (10)
1 (0)
Rescue antiemetic administered
4 (8)
0 (0)
Nausea‡
7 (14)
5 (10)
Vomiting
2 (4)
0 (0)
Rescue antiemetic administered
1 (2)
0 (0)
Nausea‡
29 (58)
23 (46)
Vomiting
15 (30)
6 (12)*
Rescue antiemetic administered
23 (46)
14 (28)
241228
371265
Complete response to prophylactic treatment [n (%)]
27 (54)
36 (72)
Complete control of emetic symptoms [n (%)]
21 (42)
27 (54)
Highly satisfied with PONV management [n (%)]
33 (66)
42 (84)*
PONV from 0-24 h [n (%)]
PONV from 24-48 h [n (%)]
PONV from 48-72 h [n (%)]
PONV from 0-72 h [n (%)]
st
1 time to vomiting episode (min)
† Values are means ± SD, numbers (n), and percentages (%)
‡ Binary nausea rating scale: Present (Yes) or absent (No) during the assessment period
* P < 0.05 vs. Control (Sham) group
16
Table 4: The Overall Incidence of Non-PONV Side Effects in the Two Study Groups†
Control (‘Sham’)
Pressure Right®
Local discomfort at the wrist [n(%)]
0 (0)
0(0)
Constipation [n (%)]
2 (4)
0 (0)
Headache [n (%)]
1 (2)
2 (4)
Fatigue [n (%)]
3 (6)
3 (6)
Drowsiness [n (%)]
2 (4)
1 (2)
Dizziness/fainting [n(%)]
0(0)
0 (0)
Device failed to remain in place for
4 (8)
6 (12)
entire 72 h study period [n(%)] #
† Values are numbers (n), and percentages (%)
nd
# Device was inadvertently removed by the patient while showering on the 2 postoperative day (all
devices were still in place at the end of the initial 24 h assessment period)
PONV = postoperative nausea and vomiting
USD = United States dollars
No significant differences were found between two study groups
17
Fig. 1: Pressure Right® strips (or sham devices without the plastic button) were applied to the ventral
aspect of both wrists at the P6 acupoints. This device is manufactured by Pressure Point, Inc., Grand
Rapids, MI. Web site: www.pressurerightstrip.com .
18