PAIN MEDICINE

SECTION EDITOR
MICHAEL J. COUSINS
A New Highly Reliable Instrument for the Assessment of
Pre- and Postoperative Gynecological Pain
Elisabet Stener-Victorin, RPT, PhD*, Jan Kowalski, BS, and Thomas Lundeberg, MD, PhD
*Department of Obstetrics and Gynecology, Go teborg University, Go teborg; Department of Physiology and
Pharmacology, Karolinska Institutet, Stockholm; and Department of Rehabilitation Medicine, Karolinska Hospital,
Stockholm, Sweden
In this study, we evaluated the reliability of a newly
developed method for pain assessment, which is based
on perceptual matching by Pain Matcher, Cefar Med-
ical AB, Lund, Sweden, during minor gynecological
surgery. In addition, the responsiveness to two differ-
ent anesthetic methodselectro-acupuncture or a fast-
acting opiate, alfentanil, both in combination with a
paracervical blockwas estimated by using Pain
Matcher and visual analog scale (VAS) assessments be-
fore and 2 h after surgery. Two hundred-twenty-three
women (aged 2238 yr) participated. The results show
that Pain Matcher is a reliable method for pain assess-
ments, with lack of random individual disagreement
and with no statistical evidence of systematic disagree-
ment in position or in concentration. The augmented
rank-order coefficient (r
a
) values were excellent (0.95
1.00). When scales were used to detect true changes
over time, there was no clear indication of responsive-
ness, mostly because of statistically significant random
individual changes. However, the individual changes
were much smaller for magnitude matching than for
VAS. In conclusion, we would recommend the use of
perceptual matching by Pain Matcher for pain assess-
ment, because in this study it was a reliable and power-
ful in test-retest situations and had smaller individual
changes than VAS after intervention. The Pain Matcher
procedure was well accepted by the patients, and the
results suggest that it may be useful when evaluating
acute pre- and postoperative pain.
(Anesth Analg 2002;95:1517)
O
ptimal pain relief and anesthesia during a minor
gynecological surgery, such as transvaginal
ultrasound-guided oocyte aspiration during in
vitro fertilization (IVF), is an important goal. Trans-
vaginal follicle puncture requires one or two needle
perforations through the vaginal wall to puncture the
follicles in the ovary, lasts for approximately 20 to
30 min, and may be the most painful component of
IVF treatment. The perceived pain during oocyte as-
piration varies to a large extent from one individual to
another and is often described in similar terms as
intensive menstrual pain (1).
The visual analog scale (VAS) has traditionally been
used as a method for evaluating the effectiveness of
analgesia. The VAS is difficult to interpret, because
two steps are involved: the patients pain rating and
the clinicians measurement of the patients line. Fur-
thermore, the VAS is bounded by fixed end points and
provides a limited range of measurement (2,3). It is
also a limited way of assessing pain intensity, because
the patient has to compare and grade perceived pain
intensity against her worst-ever experience of pain (4).
The difficulties associated with the use of VAS and its
phenomenon of a trimodal distribution have been pre-
viously reviewed (5). The VAS has a large number of
categories, and its outcome may be influenced by false
precision (6), which causes difficulties in detecting
true changes in pain. The usefulness of VAS for the
assessment of postoperative pain has been questioned
by DeLoach et al. (7). They concluded that any indi-
vidual determination with VAS has an imprecision of
20 mm; this supports the theory of the false precision
of the VAS. Because VAS is apparently not the gold
standard that it was once thought to be, new meth-
ods for pain assessment are needed. An electrical stim-
ulus against which the patient may match her per-
ceived pain with nonvisualized predetermined end
points is an alternative method for evaluating pain.
Electrical stimulation has been previously used with
few reported side effects in experimental situations
for the measurement of sensory detection and pain
thresholds (2,3). A recently developed perceptual
matching device by Pain Matcher, Cefar Medical AB,
Supported by grants from Hjalmar Svenssons Foundation and
Wilhelm and Martina Lundgrens Foundation.
Accepted for publication March 5, 2002.
Address correspondence and reprint requests to Elisabet
Stener-Victorin, Department of Obstetrics and Gynecology, Go te-
borg University, SE-413 45 Go teborg, Sweden. Address e-mail to
elisabet.stener-victorin@medstud.gu.se.
2002 by the International Anesthesia Research Society
0003-2999/02 Anesth Analg 2002;95:1517 151
Lund, Sweden, designed for clinical use in pain meas-
urement, is based on electrical stimulation applied to
the skin as a matching stimulus. This allows a contin-
uous ordinal individual response with nonvisualized
predetermined lower or upper limits. A recent study
showed that perceptual matching by Pain Matcher has
comparable reliability and responsiveness to the VAS
(8).
Assessment of pain is often measured by rating
scales, which can be defined as ordinal scaled data.
We evaluate data statistically by a nonparametric
rank-invariant method, because distances between
categories do not represent any mathematical, numer-
ical meaning, but only an order. Arithmetical methods
may therefore lead to serious misinterpretations of the
rating scales (7,911). All attempts at measures for
correlation between repeated observations to estimate
the level of agreement are false. The correlation coef-
ficient measures only the level of association. Two
measurements of VAS, for example, are expected to be
associated, but the measure of interest here is the level
of agreement (12).
The anesthetic method used during oocyte aspira-
tion must have a rapid onset, provide optimal pain
relief during the procedure, and allow a rapid recov-
ery afterward. In Sweden, the most frequently used
technique is a paracervical block (PCB) (1317) in com-
bination with IV opiates (18). Premedication with sed-
ative drugs may be used. Studies on the pain-relieving
effect of electro-acupuncture (EA) during surgery
have been conducted, including one of oocyte aspira-
tion during IVF treatment (19). EA was then shown to
be as effective as conventional anesthetics.
The main goal of this study was to evaluate the
reliability of a new method for pain measurement
perceptual matching by Pain Matcherduring a mi-
nor gynecological operation by using a rank-invariant
statistical method. In addition, we estimated the re-
sponsiveness of Pain Matcher and VAS in the assess-
ment of the acute pain before and 2 h after the oper-
ation as an effect of the two different anesthetic
methodsEA or alfentanilboth applied in combina-
tion with a PCB.
Methods
Two-hundred-twenty-three women (aged 2238 yr)
participated in this prospective, randomized, multi-
center study. All of them underwent IVF treatment
with oocyte aspiration. This is the most painful com-
ponent of IVF treatment, although most women also
have abdominal pain as a result of their hormonal
stimulation. The study was conducted at five IVF cen-
ters in Sweden (the IVF Unit at Sahlgrenska University
Hospital in Go teborg; the Fertility Center Scandinavia
in Go teborg; the IVF Center in Falun; the IVF Unit at
Karolinska Hospital, Stockholm; and the International
Fertility Center, Malmo ).
Each woman gave written, informed consent before
randomization to one of the two anesthetic methods.
The study was approved by the ethics committees of
Go teborg, Uppsala, Stockholm, and Lund Universi-
ties, Sweden.
The women were asked to rate their abdominal pain
30 min before and 2 h after oocyte aspiration. They
were also asked to rate the present pain and worst
pain experienced, directly related to and after the oo-
cyte aspiration in the operating room. Two different
pain measurement methods were used for the evalu-
ation of pain in this clinical situationa test with
electrical stimulation of the skin, producing percep-
tual matching by Pain Matcher, and VASwhile the
same questions were asked. The VAS ratings were
recorded with a horizontal mark on a 100-mm line
oriented vertically on a paper. Each VAS was scaled
0100, with end points 0 (no pain) and 100 (worst
pain). The perceptual matching with electrical stimu-
lation was performed after each VAS rating, its having
been shown previously that there are no order-related
effects between different pain assessments (8). Pain
Matcher estimates were recorded by two repeated
observations. The woman was instructed to hold an
electrode box between the thumb and index finger of
the right hand. To increase the feeling of control, a
hand switch was held in the left hand. The electrical
stimulation unit was started by the assessor and de-
livered electrical pulses at a random velocity and with
increasing intensity. When the sensation in the right
hand corresponded in amplitude to her experienced
pain, the woman was told to either press the hand
switch or release her fingers from the electrode box,
stopping the electrical stimulation. The value ob-
tained, from 0 to 60, was automatically saved. The
procedure was repeated within 15 to 30 s. The time to
introduce, give instructions for, and perform the pain
assessment was approximately the same for the two
pain measurement methods.
The perceptual matching device, Pain Matcher, a
unit that gives constant current stimulation, is con-
trolled by a microprocessor that provides rectangular
pulses with a frequency of 10 Hz and an amplitude of
10 mA. It is programmed to give a constant current
stimulation despite variable skin resistance (e.g., influ-
enced by sweating and anxiety of the subject) up to 13
k. The intensifying of stimulation is achieved by
successively increasing the pulse width from 0 to a
possible maximum of 450 s in increments of 7.5 s,
up to a total of 60 steps. The electrical charge per
second is extremely low and varies through the dif-
ferent steps from 1.5 to 45 C. The reached value
(060) is directly related to the pulse width and is
152 PAIN MEDICINE STENER-VICTORIN ET AL. ANESTH ANALG
MAGNITUDE MATCHING OF ACUTE PAIN 2002;95:1517
displayed on a liquid crystal display screen. The con-
tact surface area, and hence the resulting current den-
sity, is ensured by a certain minimum finger pressure
against the electrode; this is achieved by instructing
the patient to hold the electrode box in a horizontal
position requiring a certain minimum, predetermined
pressure. A further increase in electrode pressure does
not improve the functionality of the Pain Matcher.
Because of the electrical stimulation, patients with a
pacemaker should not use this method.
Two different anesthetic methods were used during
ultrasound-guided oocyte aspiration: EA and IV alfen-
tanil (Rapifen

; Janssen-Cilag, Sollentuna, Sweden),

both in combination with a local anesthetic, 10 mL of
lidocaine hydrochloride (10 mg/mL) (Xylocain

; As-
tra, So dertalje, Sweden), administered as a PCB imme-
diately before the aspiration procedure. The EA was
begun at least 30 min before oocyte aspiration, which
is the optimal time to allow for the onset of analgesia
and relaxation before surgery, and was terminated
directly after aspiration was complete. The type and
location of needles and form of stimulation were the
same in all women randomized to EA and were pre-
viously described in detail (19).
The women in the group randomized to receive
alfentanil were given 0.5 mg of alfentanil and 0.25 mg
of atropine IV (Atropin NM Pharma, NM Pharma AB,
Stockholm, Sweden) before the PCB was placed, di-
rectly before oocyte aspiration. The women in both
groups could ask for additional alfentanil if EA or the
initial dose of alfentanil did not produce sufficient
pain relief.
All statistical calculations were performed with the
software package SYSRAN 1.0 for Matlab 6 (OrdStat
AB, Stockholm, Sweden). To estimate the reliability
between the first and second observations recorded by
Pain Matcher, a statistical method was used without
any assumption of underlying distribution and fitted
to evaluate data as ordinal scaled data. The rank-
invariant method was developed by E. Svensson (11),
and the following measures have been estimated: sys-
tematic disagreement for the group in position (RP)
and in concentration (RC), level of random individual
disagreement (RV), and the augmented rank-order
coefficient (r
a
) (6,7,9). A systematic disagreement com-
mon to the group, measured by RP and RC, indicates
consistent disagreement between repeated assess-
ments. The presence of individual disagreement, mea-
sured by RV, corresponds to the random part of the
disagreement that could not be explained by the test-
retest bias. An RV-related measure to express the size
of random individual changes is the rank-order agree-
ment coefficient, r
a
(6,7,9). The higher the value of r
a
between 0 and 1, the less the random part of the
observed disagreement (6,11) and the lower the level
of individual change, RV. For RV values, the possible
interval is from 0 to 1, and a lower value represents
less random disagreement. Values of RP and RC close
to 0 indicate a lack of systematic disagreement. RP is
equal to 1 if there is a complete positive shift to higher
values in the assessments between two occasions.
Negative RP values mean systematically lower record-
ings. Values of RC are positive if categorical distribu-
tion on the second occasion is more concentrated to-
ward central parts of the scale compared with the
distribution on the first occasion. In the evaluation of
pain before and 2 h after oocyte aspiration, the pain
assessments are evaluated by using the same statisti-
cal parameters, but the interpretation of RP corre-
sponds to a systematic change in position: RC to a
systematic change in concentration and RV to random
individual changes. A positive change in position cor-
responds to increased thresholds for perceived pain
values from the first to the second occasion, whereas a
negative change in position corresponds to a decrease
in the measured values.
Table 1. The Median (minimummaximum) for Each Pain Measurement of Abdominal Pain (before and 2 h after
operation) and for Pain Measurement Related to the Operation by Using Pain Matcher (PM) and Visual Analog Scale
(VAS) in the Alfentanil Group (ALF) and the EA Group (EA)
Time point for pain measurement
ALF (n 112),
median (range)
EA (n 111),
median (range)
Before
VAS 4 (050) 4 (061)
PM 4 (023) 4 (060)
Directly after operationworst pain related to operation
VAS 48 (392) 53 (198)
PM 12 (343) 12 (260)
Directly after operationpresent pain
VAS 17 (081) 18 (073)
PM 6 (140) 7 (060)
2 h after operation
VAS 15 (090) 10 (070)
PM 4 (025) 4 (060)
ANESTH ANALG PAIN MEDICINE STENER-VICTORIN ET AL. 153
2002;95:1517 MAGNITUDE MATCHING OF ACUTE PAIN
Illustration of systematic disagreement for the group
is performed by the relative operating characteristic
(ROC) curve, and this is not to be confused with the
more familiar ROC curve used for sensitivity and
specificity evaluation (12). The two axes represent the
cumulative proportions of the two repeated Pain
Matcher measurements. Values of RP and RC close to 0
indicate negligible disagreement, and the corresponding
ROC curve will be close to the main diagonal (6). A
concave or convex ROC curve is a sign of systematic
disagreement in the position of the scale, and an
S-shaped ROC curve is a sign of systematic disagree-
ment of concentration of the categories. The ROC curve
was also used to demonstrate the systematic change over
time, i.e., responsiveness. Values of RP and RC close to 0
indicate an absence of systematic changes. Statistical
tests were two sided, and the level of significance was
0.05. RP, RC, and RV are presented together with their
corresponding 95% confidence intervals.
Results
Table 1 shows the median and the range (minimum
maximum) for each pain measurement with Pain
Matcher and VAS in the Alfentanil group and the
EA group, respectively. Figure 1 shows the joint
distribution between the first and the second Pain
Matcher measurements recorded before oocyte as-
piration in both groups. The ROC curves demon-
strate the systematic disagreement for the group of
the Pain Matcher measurements recorded before
oocyte aspiration in the EA and the Alfentanil
groups. The two ROC curves more or less follow the
main diagonal. This indicates an absence of system-
atic disagreement in repeated pain assessments. Ta-
ble 2 also shows the pattern of disagreement be-
tween repeated observations of perceived pain
when using Pain Matcher before, directly after, and
2 h after the oocyte aspiration. The RP values and
corresponding 95% confidence intervals showed no
evidence for systematic disagreement in position at
any time and were considered small. The results
also show a lack of systematic disagreement in con-
centration (RC). The RV values indicate a lack of
random individual disagreement in pain at all four
assessments. The augmented rank-order agreement
coefficient r
a
was excellent, from 0.953 to 0.998.
These results indicate that perceptual matching by
Pain Matcher is a reliable method.
Figure 2 shows the joint distribution between ab-
dominal pain before oocyte aspiration and 2 h af-
terward, i.e., for Pain Matcher and VAS in the EA
and the Alfentanil groups. The joint distribution
shows a large spread of scatters both for VAS and
for Pain Matcher, indicating considerable random
individual changes. The ROC curves demonstrate
the systematic group changes between abdominal
pain before and 2 h after oocyte aspiration. Both
VAS and Pain Matcher have a concave-shaped curve
that corresponds to increased levels of pain assess-
ment. Table 3 shows the pattern of changes in pain
assessment before and 2 h after oocyte aspiration for
Pain Matcher and VAS in the EA and the Alfentanil
group. The outcome from the analysis of data indi-
cates a systematic increase with respect to pain as-
sessment in both the EA and the Alfentanil groups
measured by Pain Matcher that was greater in the
VAS assessments whose RP values showed statisti-
cal significance (P 0.05). A systematic change in
concentration was indicated both by Pain Matcher
and by VAS. Statistically significant random indi-
vidual changes were demonstrated by both methods
of pain assessment but were much more obvious for
Figure 1. The joint distribution between the first and second Pain
Matcher (PM) measurements recorded before oocyte aspiration in
the EA group and the Alfentanil (ALF) group. The relative operat-
ing characteristic curves demonstrate the systematic disagreement
for the group of the magnitude-matching measurements recorded
before oocyte aspiration in the EA group and the Alfentanil group.
Cum prop cumulative proportion.
154 PAIN MEDICINE STENER-VICTORIN ET AL. ANESTH ANALG
MAGNITUDE MATCHING OF ACUTE PAIN 2002;95:1517
VAS. The presence of large random individual
changes indicates a lack of responsiveness for both
methods.
Discussion
The main result of this study was that perceptual
matching by Pain Matcher showed excellent reliabil-
ity, with a potential to capture a true responsiveness in
the assessment of intensity of acute pain experienced
before and after a minor gynecological operation. Two
repeated observations displayed excellent agreement,
which indicates that Pain Matcher is a reliable and
efficient method of pain assessment.
Responsiveness for perceptual matching is esti-
mated on the basis of patients assessments of ab-
dominal pain before and two hours after operation.
The assessment directly after the operation is re-
lated to the pain experienced during surgery and
cannot be compared with the abdominal pain before
operation. When measuring pain assessment with
Pain Matcher, we have demonstrated the systematic
group change in position for both EA and Alfentanil
groups. However, these were greater for pain as-
sessment performed by VAS. On the other hand, RV
values for VAS were very high and demonstrate a
lack of responsiveness, which has been discussed
previously (6). We recommend the use of perceptual
matching by Pain Matcher for pain assessment, be-
cause in this study it has been shown to be reliable
in test-retest situations and to have smaller individual
changes than VAS after intervention. The usefulness of
VAS could be questioned because of earlier findings of
large random individual disagreement (6,8) and, in this T
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Figure 2. The joint distribution between abdominal pain before
oocyte aspiration and 2 h after oocyte aspiration for Pain Matcher
(PM) and visual analog score (VAS) in the EA group and the
Alfentanil (ALF) group, respectively. The relative operating charac-
teristic curves demonstrate the systematic group changes between
the abdominal pain before and 2 h after oocyte aspiration for mag-
nitude matching and VAS in the EA group and the Alfentanil
group, respectively. Cum prop cumulative proportion.
ANESTH ANALG PAIN MEDICINE STENER-VICTORIN ET AL. 155
2002;95:1517 MAGNITUDE MATCHING OF ACUTE PAIN
study, significant random individual changes. In this
study, the strength of the true treatment effects are not
known, and it is possible that the use of VAS results in an
overestimation. However, this is only hypothetical, the
RV is large for VAS, and the use of the scale is very
limited. One reason why perceptual matching has less
RV is the lack of visualized predetermined end points.
When introducing a new method based on electrical
stimulation for the assessment of pain, the aspects of
safety must be considered for ethical reasons. Electri-
cal stimulation of the skin can be perceived as dam-
aging to tissue, and for that reason it is of great im-
portance that the subject have control over immediate
cessation of stimulation at any time in the procedure.
The electrical stimulation has the advantages of pro-
ducing easily detectable sensations and being easily
controlled and reproducible (3). The sensation pro-
duced by Pain Matcher is brief and perceived by most
patients as pricking, throbbing, or tingling, although
some may find it uncomfortable.
In this clinical situation, perceptual matching by
Pain Matcher was well accepted by the study subjects,
and no complications were reported, probably be-
cause the safe use of the method was explained. An-
other advantage to this new device is that visually
impaired patients can use it. This study was a multi-
center study, and more than 10 people were involved
in the reliability or responsiveness, showing a clear
advantage for the Pain Matcher technique. The draw-
back to using this kind of measure is that it demands
intact skin for pain assessments.
It should be emphasized that the rank-invariant
method used in this study is very attractive because it
can be used to separate systematic disagreement from
random disagreement, compared with, for example,
the coefficient, which can estimate only an aggre-
gated measure of reliability/disagreement (12,20).
In conclusion, perceptual matching by Pain Matcher
was shown to be a highly reliable method of pain
assessment in patients with acute pain after a minor
gynecological operation. Pain Matcher in this setting is
easy to use and was well accepted. The results suggest
that electrical perceptual matching may be useful
when evaluating acute pre- and postoperative pain.
We would like to thank the midwifes who performed the meas-
urements and collected all data: Ann-Louise Gejerwall, Charlotte
Werner (IVF Unite, Sahlgrenska University Hospital, Go teborg),
Margareta Hammar, Kia Borg, Ann-Charlotte Carlsson, Birgitta At-
tebo, Birgitta Nerman (Fertility Center Scandinavia, Go teborg),
Ragna To rnqvist (IVF center of Falun and IVF Unite Karolinska
Hospital, Stockholm), Anki Hagglund, and Eva Ellerstro m (Ideon
kliniken, Malmo ). We also want to thank Audrey Singh and An-
drew Naylor for revision of the English text and Irene Lund for
valuable comments on the manuscript.
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Variable
ALF EA
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