Fleckenstein et al. Trials 2014, 15:292
http://www.trialsjournal.com/content/15/1/292

STUDY PROTOCOL

TRIALS
Open AccessAcupuncture for post anaesthetic recovery andpostoperative pain: study protocol for arandomised controlled trial
Johannes Fleckenstein1,2,3*, Petra I Baeumler1, Caroline Gurschler1, Tobias Weissenbacher4, Michael Simang5,
Thorsten Annecke2, Thomas Geisenberger2,6 and Dominik Irnich1,2Abstract
Background: We report on the design and implementation of a study protocol entitled Acupuncture randomised
trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate theeffectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery andpostoperative pain.
Methods/Design: The study is designed as a randomised controlled pilot trial with three arms and partial double
blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in astandardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries
will be allocated randomly to one of the three trial arms. The total observation period will begin one day before
surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administeredpreoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to ‘readyfor discharge’ from the post anaesthesia care unit (in minutes). The ‘ready for discharge’ end point will be assessedusing three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House
score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain,
nausea and vomiting, concomitant medication).
Discussion: The results of this study will provide information on whether acupuncture may improve patient postanaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic
differences between invasive and non-invasive acupuncture techniques.
Trial registration: NCT01816386 (First received: 28 October 2012)

Background
Perioperative care has improved over the last decades.
To continue this trend it is important note that the quality and speed of post anaesthetic recovery is influenced
by multiple factors such as the occurrence of pain, postoperative nausea and vomiting (PONV), paralytic ileus,
fatigue and sleep disturbances [1]. Hence, a multimodal
approach to prevent and minimise these factors is considered to be essential in order to enhance recovery [2].
These include a series of elements such as providing the* Correspondence: Johannes.Fleckenstein@ikom.unibe.ch
1Multidisciplinary Pain Centre, Department of Anaesthesiology, University of
Munich, Pettenkoferstrasse 8 A, 80336 München, Germany
2
Department of Anaesthesiology, University of Munich, München, Germany
Full list of author information is available at the end of the article

patient with thorough preoperative information and education concerning perioperative care, the use of safe andshort-acting anaesthetics and optimal dynamic pain relief with minimal use of opioids, management of PONV,
enteral nutrition, early mobilization and use of minimal
invasive surgery. As a result of optimised anaesthetic protocols, patients might be fully awake earlier and breathe comfortably in the operating theatre [3]. As a result of a more
rapid recovery, fewer patients arrive in the post anaesthesia
care unit (PACU) sedated, and the period during which
they are at risk for airway obstruction and hemodynamic
instability is reduced [4].
For achieving an optimised management of postoperative
pain and PONV, acupuncture may be a hitherto underestimated option. Interest in the use of acupuncture in© 2014 Fleckenstein et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of theCreative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use,
distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public
Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in thisarticle, unless otherwise stated.

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anaesthesia leads back to 1971, when James Reston, a
The New York Times columnist, introduced the westernworld to the ancient Chinese therapy of acupuncture[5]. Reston underwent an emergency appendectomy in
China, and described acupuncture’s success in relieving
his postoperative pain. From this point on, several scientists started investigating possible effects of acupuncture. Soon, Bruce Pomeranz revealed that an analgesic
effect of acupuncture is mediated by the release of endorphins and can therefore be abolished by the administration of naloxone in humans [6]. Mice deficient in opiate
receptors did not experience acupuncture-mediated analgesia [7], which confirms the opioid-related mechanism ofacupuncture-analgesia. Soon, first articles reported on thebenefits of acupuncture anaesthesia in various operative procedures in China [8,9]. As a consequence, firstattempts were made to implement acupuncture in theanaesthetic framework [10], for example, as an option
for sedation of the patient during tonsillectomy [11]. A newmodified method of anaesthesia in open heart surgery combining acupuncture analgesia and controlled respiration
was established at the Department of Anaesthesiology in
Gießen, Germany [12]. Since then, general anaesthesia has
markedly improved and acupuncture anaesthesia cannot
be considered a first-line procedure.
However, there is evidence that acupuncture is effective in facilitating multimodal approaches in perioperativecare. An approved acupuncture effect is the reduction of
PONV and antiemetic consumption by stimulation of theacupuncture point PC 6 [13]. Recent reviews support
the effectiveness of acupuncture regimen in reducing
postoperative pain, cumulative opioid consumption or
opioid related side effects [14,15]. However, trials areof varying quality and show heterogeneity with regard
to the applied acupuncture treatments (acupuncture
points used, time point of application). Accordingly, ameta-analysis on the effects of acupuncture on the intraoperative analgesic consumption and quality of anaesthesia
revealed inconclusive results [16].
We aim to investigate the effects of a three-day permanentneedle acupuncture treatment, starting in the preoperative
phase at seven different acupuncture points only - fiveof them bilaterally - on a comprehensive set of above
mentioned variables important to anaesthetic recovery(which are, preoperative anxiety, improving anaesthetic
protocols, awakening, nausea and vomiting, and postoperative pain).

Patients and methods

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gynaecologic laparoscopic operations. Main outcome
measure is the time from extubation to ‘ready for discharge’
from the PACU. Analysis of all records is performed byblinded evaluators. The total follow-up period per patientis two days (see Figure 1). The study has been approvedby the Ethics Committee of the University of Munich,Germany (reference 009-12) and is in agreement with
the Declaration of Helsinki (Version Fortaleza 2012).
Trial registration is NCT01816386.
Patients

For inclusion, patients must meet the following criteria:
 Age 18+
 Females scheduled for laparoscopic surgery ofuterus, adnexa or ovaries
 American Society of Anaesthesiologists (ASA)-score ≤ 2
 Ability to follow study instructions and likely toattend and complete all required visits Written informed consent

Subjects presenting with any of the following exclusion
criteria may not be included in the trial:
General exclusion criteria:
 Subject without legal capacity
 Subject who is unable to understand the nature, scope,

significance and consequences of this clinical trial
 Simultaneously participation in another clinical







trial or participation in any clinical trial involving
administration of acupuncture within 30 days prior
to inclusion
Subjects with a physical or psychiatric condition whichat the investigator’s discretion may put the subject at
risk, may confound the trial results, or may interferewith the subject’s participation in this clinical trial
Known or persistent abuse of medication, drugs or
alcohol
Current or planned pregnancy or nursing women
Females of childbearing potential, who are not using
and not willing to use medically reliable methods ofcontraception for the entire study duration (such as
oral, injectable, or implantable contraceptives, orintrauterine contraceptive devices) unless they are
surgically sterilised/hysterectomised or there are anyother criteria considered sufficiently reliable by theinvestigator in individual cases.

Indication specific exclusion criteria:

Study design

The study is a single-center, partially double blinded,
randomised pilot trial comparing (a) press needle acupuncture versus (b) no treatment versus (c) press plaster acupressure in a standard anaesthetic setting of programmed

 Surgery within the last three months
 Chronic pain > three months
 Continuous analgesic medication with opioids

longer than three days

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Figure 1 Study design. Patients are randomly allocated to either the group ACU (press needle acupuncture), no treatment group (control) or thegroup APU (press plaster acupressure). After surgery, press needles and press plasters will be kept on the patients’ skin for the next two postoperativedays or until discharge from the hospital. The listed outcome measures will be assessed at the marked time points respectively.

 Massive degenerative diseases
 Pre-treatment with acupuncture or trigger point

injection within the last two months
Randomised treatment allocation, blinding andsample-size estimation

Informed consent will be obtained from each participant.
Subjects eligible for participation will be randomly
assigned to one of the following study groups by using theInternet based randomisation software RANDOULETTE®
(Institute of Medical Information Sciences, Biometry andEpidemiology, University of Munich): press needle acupuncture: 25 subjects
 no treatment control: 25 subjects
 press plaster acupressure: 25 subjects

Stratification for age will be performed, and an equal
distribution between treatment arms (ratio of 1:1:1) will
be warranted.
In this trial we will use acupressure (group C) as
an intervention to compare acupuncture (group A).
Patients and examiners will be blinded for the patients’assignment to treatment arms A and C. Therefore, we usepress needles (0.2 mm × 1.5 mm; Seirin New Pyonex®,
Seirin Corp., Shizuoka City, Japan) in group A and noninvasive Seirin press plasters in group C - a device thathas successfully been validated for blinding in acupuncture trials [17]. Press plasters do not contain a needle but
a blunt knob and are in all other aspects identical to thepress needles. According to group allocation, press needles
or press plasters will be administered by an independentacupuncturist at the same defined acupuncture points. Instructions regarding point stimulation for subjects andstudy staff will also be identical. Thereby, patients and examiners will be blinded as laid down in the trial of Myazaki and colleagues who showed that neither patientsnor therapists nor examiners know if a sharp tip or ablunt knob is located below the plaster. In contrast to
Myazaki, patients will be allowed to stimulate theirpress device, so that an additional acupressure effectmay be elicited, thereby enhancing the overall effects.
Participating trial physiciansParticipating trial physicians are employees of the Multidisciplinary Pain Centre, Department of Anaesthesiology,
University of Munich, Germany. Their average qualification is at least equal to a third year resident in the field ofFleckenstein et al. Trials 2014, 15:292
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Page 4 of 9anaesthesiology and specialised pain medicine. They
contribute to all medical duties.
The acupuncturists are physicians at the Multidisciplinary
Pain Centre, Department of Anaesthesiology, University of
Munich, Germany, who have passed more than 360 hoursof curricular teaching in TCM and acupuncture and whoroutinely use acupuncture in daily clinical practice.
Anaesthetic proceedings

All standardised medication will be permitted according to
the perioperative anaesthetic guideline and to the standard
perioperative pain guideline, Department of Anaesthesiology,
University of Munich, both based on general recommendations and guidelines of the German Society for
Anaesthesiology (DGAI). In particular:
opioids and propofol for intraoperative anaesthesia will
be administered by Target Control Infusion (TCI) according to the standard protocol. TCI is a software based on
pharmacokinetic models according to Schnider, used in
the Fresenius-Kabi Orchestra® Base Primea syringe pumps(Fresenius Kabi Group, Bad Homburg, Germany). It requires age, gender, height and total body weight as input
for programming. The software calculates the lean bodymass for the patient and determines doses and infusion
rates accordingly to achieve the necessary drug concentrations at the effect site (brain). The aspired effect-site concentrations are reported in Table 1.
To avoid postoperative pain all patients receive metamizol
2.5 g iv-infusions and to prevent PONV they receive dexamethasone 8 mg iv and for prevention of gastric stress ulcer
they receive ranitidine 50 mg iv during surgery.
Postoperatively, subjects are treated for pain with metamizol (4 × 1.25 g/day) and the opioid piritramide (PCA; 2 mg
each 10 minutes; maximum dosage 30 mg/4 hours). In
case of nausea and vomiting or shivering, patients aretreated according to the clinical standard.
Variations of this guideline based regimen are allowed if
medically indicated. All concomitant therapies or medication are documented in the subjects’ clinical record file.
Interventions

Patients in the acupuncture and the acupressure groupwill receive a standardised treatment with either 12 press
needles (sharp tip) or 12 press plasters (blunt knob) at 7
acupuncture points (Du 26 and Ren 17 (on the middle
body line), and bilateral LI 4, HE 7, LV 3, ST 36 and PC 6;

see Figure 2). The needles have been provided by the
SEIRIN Corporation, Shizuoka City, Japan. The point regimen is based on inquiring national experts. Application of
the press needles or press plaster is performed and documented by a licensed medical acupuncturist 12 to 24 hours
prior to surgery. Application time is supposed to be 72 to
96 hours. Modification will be allowed, in particular lesspoints according to the patient’s reaction during treatment.
The patient will be instructed to press the needles orplasters as often as they like, especially when they are
suffering from anxiety, pain or nausea and vomiting.
Patients are given an illustrated summary of the acupuncture points with the respective key symptoms, formemorization (see Figure 2). Stimulation of the press
needles or press plasters has to be done at least threetimes a day, each time at a minimum of four different
points, each for about 30 seconds. If the patient is notable to perform the daily manipulation by herself, thetrial physicians are required to manipulate instead. During
emergence, that is starting with the end of anaesthetic drug
administration, the trial team or the anaesthetist is required
to stimulate at acupuncture point Du 26.
Patients allocated to the control group will undergo
the standard anaesthetic procedure only.
Outcome measures

Main outcome measure:
Time from extubation to ‘ready for discharge’ from the
PACU is defined as the latest time necessary to achieve theminimum score allowing for discharge score as assessed inthree independent recovery scores. The used scores include
the Aldrete score [18], the Post Anaesthetic Discharge
Scoring System PADSS; [19] and the modified In-House
score for outpatients of the Department of Anaesthesiology,
University of Munich (for comparison see Table 2). All
scores consist of five items regarding different postoperative
physiologic states of the patient, which are graded from 0
to 2 (see Table 2). A summated score of 9 to 10 indicatesthat the patient is ready for discharge. The In-House score
includes three additional ‘yes-no’ questions assessingorientation, input and output which have to be answeredwith ‘yes’, too. If all scores are fulfilled the patient is graded
as ready for discharge.
Secondary outcome measure:In the pre- the intra- and the postoperative period(in PACU and at the ward) additional outcomes will beassessed (Figure 1).

Table 1 Estimated effect-site concentrations
Propofol

Sufentanyl

Induction of anaesthesia

4.0 to 9.0 μg/ml

0.2 to 0.4 ng/ml

Maintenance of anaesthesia

3.0 to 4.0 μg/ml

0.12 to 0.22 ng/ml

The effect-site concentrations are targeted during induction and maintenanceof anaesthesia and form part of the standardised anaesthetic procedure
during surgery.

 Preoperative period○ Preoperative anxiety (State-Trait Anxiety
Inventory: STAI [20])▪ at baseline▪ in the morning of the surgical day▪ immediately before induction of anaesthesia

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Figure 2 Acupuncture points hand out. The figure illustrates the seven acupuncture points as being distributed to the patients. The listed
symptoms indicate the key indications for the respective points. The chart is handed out to the patients in the acupuncture (ACU) and
acupressure (APU) groups, the given indications are thought as reminder for the patients of the possible treatment effects to be expected whenself-palpating the respective points. Du 26 has to be pressed by the attending anaesthetist during emergence.

○ Vital signs (heart rate and blood pressure) atbaseline○ Pain intensity at rest at baseline○ Laboratory parameters according to the surgicalpreoperative standard at baseline
 Intraoperative period○ Intraoperative drug consumption (analgesics,
sedatives)○ TCI effect-site concentrations○ Vital signs (heart rate and blood pressure)○ Bispectral Index (BIS) monitoring (recording
starts prior to induction of anaesthesia)○ Organisational time points (for example,
incision to closure time; intubation to
extubation time, and so on)○ During emergence, the time point when
stopping the TCI device, time to recovery of
spontaneous breathing and time to extubation,
time to eye opening, time to squeezing of theanaesthesiologists hand on command andorientation to time and place will be recorded if
possible○ About 15 minutes before the end of surgery,
analgesia applied through the TCI pumps will
be reduced (expected emergence 15 minutes)

to facilitate recovery and time will berecorded. Time to extubation is defined as thetime between end of anaesthesia andextubation.
 PACU○ Time course and comparison of recovery scores(Aldrete score, PADSS, In-House scoring system)○ Pain intensity○ Analgesic consumption○ Concurrent medication○ Occurrence of surgical- or anaesthesia-related
events▪ PONV▪ Shivering▪ Others○ Vital signs
 Postoperative period (on the ward)
Patients will be visited after discharge from the
PACU based on a fix scheme, which is six hours
after, and three times daily on the two following
postoperative days unless the patient has beenpreviously discharged from the hospital. The
following parameters will be assessed:○ Vital signs○ Pain intensity

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Table 2 Recovery scores in the post anaesthesia care unit
Sub-items (0 to 2 points)

Aldrete score

Activity

4 extremities, 2 extremities, 0 extremities

YES

Respiration

Deep breath, Dyspnoea, Apnoea

YES

Circulation/Vital Signs

BP ± 20 mm/20% to baseline, BP ± 20 to 50 mm/20 to 40%
to baseline, BP ± 50 mm/40% to baseline

YES

Consciousness

Awake, Arousal on calling, Not responding

YES

ColourNormal, Pale, Cyanotic

YES

Activity, Mental Status

Oriented and steady gait, Oriented or steady gait, Neither

YES

Pain, Nausea, Vomiting

Minimal, Moderate, Severe

YES

YES, Pain and PONV areboth individually assessed

Surgical Bleeding

Minimal, Moderate, Severe

YES

YES

Intake and Output

Oral fluids and voided, Oral fluids or voided, Neither

YES

Ability to arise

By itself, no nausea, With assistance only, Not possible, Nausea

YES

Person, Place, Time‘yes-no’ question

Orientation

a

PADSS

In-House score

YES

YES

‘yes-no’ question

Intakea‘yes-no’ questiona

Output≥9

Score considered for discharge from PACU

≥9

≥ 9 and fulfill all ‘yes-no’questions

YES indicates that the item forms part of the questionnaire. Each item consists of three sub-items which are rated with 0 to 2 points with 2 points reflecting the normal
physiologic state. aconcerns three items of the In-House score which can only be answered as ‘yes’ or ‘no’. All scores have to be 9 or greater for patients being considered ‘ready for discharge’. In case of the In-House score, the three ‘yes-no’ questions have to be answered with ‘yes’. PADSS: Post Anaesthetic Discharge Scoring System.

○ Quantity and frequency of stimulated
acupuncture points○ Analgesic consumption○ Concurrent medication○ Occurrence of surgical- or anaesthesia-related
events▪ PONV▪ Shivering▪ Others
Sample size calculation

No sample size calculation could be established because
at the time of designing the trial there were no parameters
available from prior studies. However, we estimated thesample size on the basis of an a priori analysis using
G*Power (Version 3.1.3, University of Düsseldorf, Germany,see Table 3). We conservatively anticipated the effect sizeof the tested intervention to be small to medium (d = 0.4,
according to Jacob Cohen [21]), which results in a sample
size of 66 patients for three study groups. A further adjustment for non-parametric testing and drop outs by
15% results in a total sample size of 75 patients.

nonparametric method, the Kruskal-Wallis test will beapplied. Post hoc tests will be performed by pairwise comparisons of the three study groups by the Mann-Whitney
U-test and subsequent Bonferroni adjustment for multiple
comparison (P-value times three). Primary outcome is defined as the time to discharge from PACU in the press
needle acupuncture group in comparison to the no treatment group.
For the secondary target variables, a method according
to the distribution of data will be performed. For metricvariables, the structure of a normal distribution will betested by the Kolmogorov-Smirnov test. In case of a normal
Table 3 Sample size calculation
F tests:

ANOVA: Fixed effects, omnibus, one-way

Analysis:

A priori: Compute required sample size

Input:

Effect size f= 0.4

α err probability= 0.05

Power (1-β err probability)= 0.8

Number of groups=3

Noncentrality parameter λ= 10.5600000

Critical F= 3.1428085

Data analysis

Numerator df=2

The aim of the statistical analysis is the comparison of
the main outcome measure (period from extubation to‘ready for discharge’ from PACU) between the threestudy groups (intervention groups acupuncture andacupressure and no treatment control). For this variable, an non-normal distribution is assumed. Hence, aDenominator df= 63

Total sample size

= 66

Actual power= 0.8

Output:A priori analysis as calculated and exported by G*Power (Version 3.1.3, University of
Düsseldorf, Germany), anticipating a small to medium effect size f = 0.4, the
α-error = 0.05 and the power = 0.8.

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distribution, a one-way ANOVA will be calculated. Otherwise a nonparametric test for independent observations likethe Kruskal-Wallis test will be carried out.
The analysis of categorical data is conducted by thechi-square goodness-of-fit test. The binary case is treatedby the chi-square-test of independence.
Data analysis will be performed with the SPSS statisticalsoftware system, version 15.0 (SPSS Inc., Chicago, IL, USA)and with SAS/STAT® Software (SAS Institute Inc., Cary,
NC, USA). All data entry will be carried out twice.

Discussion
The AcuARP trial investigates the effectiveness of acupuncture on post anaesthetic recovery and its use as an
adjunct therapy to improve patient’s recovery in the whole
perioperative setting.
Inclusion and exclusion criteria were held pragmaticin order to facilitate screening and recruitment. The
chosen trial population is homogeneous and the operations undertaken are common; hence a maximised andimproved routine care would be of general interest.
Limitations include the restricted sample size as thetrial was planned as a pilot study. In case of a positive
study outcome, further confirmatory studies will be needed.
In addition, a standardised clinical procurement, using
strictly standardised anaesthesia and standardised acupuncture regimen may impede generalizability of the findings.
Acupressure as a control procedure

The investigators have chosen acupressure as a control
procedure in this trial as it provides the possibility ofblinding both patients and examiners. Successful patient blinding using the press needle/plaster device has
been proven by Miyazaki et al. [17]. Examiners will beblinded too, since they do not know if a sharp needle(acupuncture) or a blunt knob (acupressure) is locatedbelow the plaster [17].
This special trial design will allow us to assess different
needle-specific treatment effects [22]: on the one hand,using a needle tip, acupuncture will be performed bypenetrating the skin causing specific physiologic effects.
Those may be distinguished from similar physiologic effects caused by acupressure, on the other hand, which
can also be a strong stimulus by touching and kneading
the skin, but without penetration. Emotional, hormonaland affiliative responses to touch have already been assured [23]. By comparing acupuncture to acupressure,
this trial will provide important evidence not only about
the importance of the needle stimulus of acupuncture
but also about whether acupressure might also bringabout a therapeutic benefit in the perioperative setting.
This in particular seems to be of interest when taking
into account patient populations that are at higher riskof suffering from side effects from local bleeding.

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The use of press needles was also chosen for otherreasons. Perioperative treatment has to be practicable,
applicable, safe and scientifically approved. The practicability will be given, as press needles have only to be
fixed once: for this trial after inclusion, feasible in daily
routine along with the anaesthesiologic consent. The
chosen acupuncture sites are not within the surgicalarea. Patients can easily access the needles and press
them if necessary. Press plasters are water resistant andsustain up to one week. The safety of acupuncture has
been described in depth, suggesting that acupunctureis free of severe side effects and being considered a safeintervention [24]. Blunt rather than sharp knobs areeven less traumatic. There is a small number of trials
dealing with the safety of press needles; one long-term
observation over one year in cancer patients suggests a
ratio of 10% of minor side effects, mostly rashes [25].
Furthermore, press needles are short (1.7 mm) and needling sites are located in a safe distance from inner organs.
Thus, severe adverse events such as pneumothorax or injury of inner organs are avoided. The scientific proof waspreviously subject to other trials, suggesting that it is worth
using acupuncture in the perioperative setting [14,15].
Study design

We have chosen to apply acupuncture or acupressure asinterventions in a three-armed double blinded randomised
controlled trial.
First, acupuncture in its philosophic meaning is notprimarily supposed to ‘cure’ illness - the underlying idea
is that acupuncture may harmonise Qi, which is a Chineseconcept of vitality or energy, and other tensions of thehuman body which can lead to feelings of pleasantness,and the alleviation of respective symptoms [26]. Several
trials have shown its use different settings, for example
in pain at obstetric delivery [27], chronic pain conditions[28], nausea and vomiting [13], seasonal allergic rhinitis[29], dysmenorrhoea [30], and so on. Hence acupuncture
is known to alleviate primary symptoms.
Second, previous trials showed that single acupuncture
points exist which are sensitive to alleviate specific symptoms relevant to the perioperative period, such as pericardium 6 (PC 6) in the treatment of postoperative nausea andvomiting [13]. Other reports suggest Governing Vessel 26(Du 26) may be successful in shock resuscitation [31] or thearea between Large intestine 8 and 10 (LI 8 and LI 10) in
acute tonsillitis and pharyngitis [32]. Acupressure at Stomach
36 (ST 36) was able to shorten the time to first flatus
passage, oral liquid intake, and improve gastrointestinal
function in patients after abdominal surgery [33].
Third, several trials could already demonstrate its
effectiveness in reducing preoperative anxiety [34], theamount of anaesthetic medications [14] or postoperative pain [15]. Most of these trials have been performed

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using ear acupuncture and only a minority using traditional acupuncture.
All these key facts regarding acupuncture taken together
suggest that it may be a useful adjunct in the perioperative
period. Thus, our aim was to develop an effective and easily
applicable acupuncture regimen for the complementary
support of post anaesthetic recovery. Emphasis should
focus on applicability, which is to reduce the number ofneedling events: therefore we choose the use of press
needles in this trial, providing availability of the treatment
for the patients during the whole perioperative period.
Regarding an effective acupuncture, we have chosen
acupuncture points which are supposed to alleviate perioperative symptoms. The decision has been made on thebasis of a consensus process taking historic transmission
but also scientific knowledge into account.
Anaesthetic regimen

The choice of a strictly standardised anaesthetic regimen
allows for comparability of all intra- and postoperative
measures. The decision to conduct the study within thegynaecologic theatre was on the one hand due to theabove mentioned uniform study population, on the other
hand driven by the fact that the anaesthetic regimen inthis clinic is extended for the use of TCI. TCI systems
for dosage of propofol have been available since 1997,
were initially developed for adult patients, with the dosage based on the basis of simulated concentration of the
drug in the plasma for review: [35]. In the following,taking into account the rate at which the drug enters
the biophase of other tissues, that is the brain, the systems
were adjusted to the concentration in the so-called effector
sites. Today, the systems give the possibility to programme
the dosage of various intravenous drugs according to different pharmacokinetic models, which, in brief, differ on thebasis of research conducted to assess the suggested rates ofinfusion. The two systems mainly used are the pharmacokinetic models for propofol as established by Marsh [36] andSchnider [37]. The Marsh model operates with fixed rate
constants, whereas compartment volumes and clearances
are weight proportional. The Schnider model was developed during combined pharmacokinetic-pharmacodynamic
modelling studies, adjusting according to total weight, leanbody mass, and height. It is recommended for the use ineffect-site targeting mode for review: [38].
The time course of plasma/effect-site equilibration isused to describe the rate of removal of drug from theeffect-site out of the body. With effect-site targeting,
the TCI system manipulates the plasma concentrationto achieve the effect-site concentration as rapidly as
possible. When the effect-site target concentration isincreased, the TCI system briefly increases the plasma
concentration to an optimal level above the target effectsite concentration before temporarily stopping the infusion

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to allow the plasma concentration to decrease to thelevel of the target effect-site concentration. If the target
effect-site concentration is reduced, the system stops
the infusion allowing the plasma concentrations to fall,
thereby generating a concentration gradient out of theeffect-site, until the estimated effect-site concentration
has fallen to the new target [38].
In our believe, the use of TCI is an adequate variable tomonitor and compare intraoperative drug consumption
when the estimated effect site concentrations is defineda priori, and may therefore be helpful in reducing bias
from individually administered anaesthetic drugs. To ourknowledge, to date, there is no better system which would
improve comparability of different study groups.
This study is a three-armed, partially double blinded,
randomised controlled trial to evaluate the effectivenessof acupuncture on the post anaesthetic recovery period
as assessed by the time from extubation to ‘ready fordischarge’ from the PACU. It can be expected to provide
valuable new information on the clinical effectivenessof acupuncture improving post anaesthetic recovery
parameters, which are a) preoperative anxiety relief,b) perioperative variables of anaesthesia and narcotic
guidance, c) the occurrence of postoperative pain andanaesthetic side effects such as PONV or shivering.
The comparison between press needle acupuncture involving a sharp needle tip and acupressure will provide
important information about a) the physiologic effectof the needle stimulus compared to pressure and its impact
on relieving perioperative symptoms and b) if both treatments are useful adjuncts in the routine perioperative care.

Trial status
The status of the study at the time of first manuscript submission is ongoing, and we had included 50 patients.
Abbreviations
ACU: acupuncture; APU: acupressure; ASA: American Society ofAnaesthesiologists; BIS: Bispectral Index; DGAI: German Society for
Anaesthesiology; PACU: post anaesthesia care unit; PADSS: Post Anaesthetic
Discharge Scoring System; PCA: patient controlled analgesia;
PONV: postoperative nausea and vomiting; STAI: State-Trait Anxiety
Inventory; TCI: Target Controlled Infusion; TCM: Traditional Chinese medicine.
Competing interests
All authors declare that they have no competing interests and did notreceive any honorarium from SEIRIN® or other partners. The investigator-initiatedgrant received by SEIRIN® guarantees independent conceivability of the study
design, its coordination, realisation and independent report of the study results.
Authors’ contributions
JF: conception and design, funding, data collection, manuscript writing andfinal approval of the manuscript. PB: conception and design, data collection,
manuscript writing and final approval of the manuscript. CG: design, datacollection, manuscript writing and final approval of the manuscript. TW: dataacquisition, critical revision and final approval of the manuscript. MS:
statistical study design, critical revision and final approval of the manuscript.
TA: data acquisition, critical revision and final approval of the manuscript. TG:
conception and design, critical revision and final approval of the manuscript.

Fleckenstein et al. Trials 2014, 15:292
http://www.trialsjournal.com/content/15/1/292

DI: conception and design, financial support, manuscript writing, final
approval of manuscript. All authors read and approved the final manuscript.
Acknowledgements
Parts of the study constitute the topics of the medical thesis of Caroline
Gurschler. The study has been funded in parts by SEIRIN®.
Author details
1
Multidisciplinary Pain Centre, Department of Anaesthesiology, University of
Munich, Pettenkoferstrasse 8 A, 80336 München, Germany. 2Department ofAnaesthesiology, University of Munich, München, Germany. 3Department of
Traditional Chinese Medicine/Acupuncture, Institute of Complementary
Medicine IKOM, University of Bern, Bern, Switzerland. 4Department of
Obstetrics and Gynaecology, Ludwig-Maximillians-University Hospital,
München, Germany. 5Institute for Medical Information Sciences, Biometry
and Epidemiology (IBE), University of Munich, München, Germany.
6
Department of Anaesthesiology, Hospital of the City of Tuttlingen,Tuttlingen, Germany.
Received: 19 February 2014 Accepted: 1 July 2014
Published: 21 July 2014
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doi:10.1186/1745-6215-15-292
Cite this article as: Fleckenstein et al.: Acupuncture for post anaesthetic
recovery and postoperative pain: study protocol for a randomised
controlled trial. Trials 2014 15:292.