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Prévia do material em texto

Contraception 88 (2013) 730–736
Original research article
Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized
controlled trial☆,☆☆,★
Rebecca H. Allen⁎, Christina Raker, Vinita Goyal
Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI 02905, USA
Received 2 May 2013; revised 15 July 2013; accepted 26 July 2013
Abstract
Objective: To determine the effectiveness of 6 mL of 2% lidocaine cervical gel for pain during intrauterine device (IUD) insertion.
Study Design: This is a randomized double-blind placebo controlled trial of 6 mL of 2% lidocaine gel for IUD insertion pain among first-
time IUD users. No other analgesia other than the study intervention was provided. The study was conducted at a university-based obstetrics
and gynecology clinic. The primary outcome, pain during IUD insertion on a 0 to 100-mm visual analog scale, was analyzed using the t test.
Results: Seventy-three women received placebo gel, and 72 women received 2% lidocaine gel. The groups had similar sociodemographic
and clinical characteristics. Baseline pain scores with speculum insertion were no different between the two groups. The lidocaine group
reported a mean pain score with tenaculum placement of 37.5 (median: 39) compared to the placebo group of 41.6 (median: 37) (p=.4).
Similarly, pain with IUD insertion was no different with a mean pain score of 35.2 (median: 34) in the lidocaine group and 36.7 (median 36)
in the placebo group (p=.8).
Conclusions: Two percent lidocaine gel placed on the anterior lip of the cervix and at the internal os did not reduce pain with tenaculum
placement and IUD insertion compared to placebo gel.
Implications: Among first-time IUD users, including both nulliparous and multiparous women, 6 mL of 2% lidocaine gel placed on the
anterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared to
placebo gel.
© 2013 Elsevier Inc. All rights reserved.
Keywords: Pain; Intrauterine device; Intrauterine system; Anesthesia
1. Introduction
As of 2008, only 5.5% of women using contraception in
the United States reported relying on the intrauterine device
(IUD) [1]. Increased use of IUDs is desirable because the
method is a safe, highly effective, long-acting means of
contraception that reduces unintended pregnancies [2,3].
One barrier to IUDs for contraception is the fear of pain
during insertion [4]. Components of the insertion procedure
that may cause pain include the tenaculum applied to the
cervix to straighten the cervical canal and passing the uterine
sound and IUD inserter tube through the internal os of the
☆ Source of funding: The Society of Family Planning Grant SFP4-4.
☆☆ Financial Disclosures: None.
★ ClinicalTrials.gov Identifier: NCT01292447.
⁎ Corresponding author. Tel.: +1 4012741122x2724; fax: +1 40153 7684.
E-mail address: rhallen@wihri.org (R.H. Allen).
0010-7824/$ – see front matter © 2013 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.contraception.2013.07.009
cervix [5]. Immediately after placement, the IUD may
stimulate myometrial contractions causing pain [5].
Factors associated with pain during IUD insertion include
nulliparity, lengthier time since last pregnancy or last menses,
history of dysmenorrhea, anticipated pain, not currently
breastfeeding and older age [6–11]. Studies have shown that
up to 21.3% of nulliparous women report severe pain during
IUD insertion, and nulliparous women report greater pain
during IUD insertion than multiparous women [6,7,11].
There are no proven interventions for pain control during
IUD insertion [12]. Although widely used, both 400 mg and
800 mg of ibuprofen prior to insertion are ineffective [7,13].
Misoprostol also fails to provide decreased pain during IUD
insertion [14,15]. Topical 2% lidocaine gel on the cervix is
another option for pain control for IUD insertion. This is
employed in the UK but has not been adopted widely in the
US [16,17]. One early trial in 1996 showed decreased pain
with 6 mL of 2% lidocaine gel; however, that study lacked
http://dx.doi.org/10.1016/j.contraception.2013.07.009
http://dx.doi.org/10.1016/j.contraception.2013.07.009
http://dx.doi.org/10.1016/j.contraception.2013.07.009
mailto:rhallen@wihri.org
http://dx.doi.org/10.1016/j.contraception.2013.07.009
731R.H. Allen et al. / Contraception 88 (2013) 730–736
proper blinding and allocation concealment [12,17]. Since
lidocaine gel does not require an injection, it may be pre-
ferable to a paracervical block, which can be painful to
administer. In fact, in one study, a 10-mL 1% lidocaine
paracervical block did not result in a statistically significant
decrease in pain with IUD insertion [18]. However, this same
study did show a decrease in pain with tenaculum placement
after 2 mL of 1% lidocaine was injected into the anterior lip
of the cervix. Two more recent randomized placebo-
controlled trials have failed to find that 2% lidocaine gel
applied to the cervix decreased pain with IUD insertion. The
first trial used 1 mL of gel applied to the internal os of the
cervix with a cotton swab for 1 min for a dose of 20 mg
of lidocaine [10]. In the second trial, all subjects received
800 mg of ibuprofen and 0.5–1 mL of gel on the anterior lip
of the cervix as well as 2–3 mL of gel at the internal os for
3 min for a dose of 50 mg to 80 mg of lidocaine [19].
The purpose of this study was to test the efficacy of 3 mL
of 2% lidocaine at the anterior lip of the cervix and 3 mL in
the cervical canal for 3 min for pain control with tenaculum
placement and IUD insertion. This lidocaine dose, 120 mg,
and application protocol are identical to the 1996 study by
Oloto et al. Our aim was to replicate this study in a proper
randomized, placebo-controlled trial to determine the effec-
tiveness of 2% lidocaine gel. We chose a 3-min waiting
period to allow for the absorption of topical lidocaine gel.
The product information for 2% lidocaine gel states that 3 to
5 min is required for absorption [20]. We also sought to
describe participant satisfaction with pain control and any
side effects associated with 2% lidocaine gel.
2. Materials and methods
We conducted a randomized, double-blind, placebo-
controlled trial at a university obstetrics and gynecology
practice in Providence, RI, from March 2011 to July 2012.
The Women and Infants Hospital Institutional Review Board
granted approval for the study protocol, and all patients
provided written informed consent. English or Spanish-
speaking women 18 to 49 years old requesting IUD insertion
for contraception or abnormal uterine bleeding were
approached for participation. Inclusion criteria included no
prior IUD use, more than 6 weeks postpartum or 2 weeks
postabortion if recently pregnant, no analgesics or anxio-
lytics in the previous 12 h and no misoprostol use prior to
insertion. Exclusion criteria included any contraindication to
IUD placement, allergy to lidocaine or sensitivities to com-
ponents of the lidocaine or placebo gel and chronic narcotic,
benzodiazepine or barbiturate use within the past year. Sub-
jects chose the type of IUD desired, either the CuT380A IUD
or the levonorgestrel IUD.
After consent and study enrollment by study staff, par-
ticipants were randomized to one of two groups, 2%
lidocaine gel or placebo gel (KY Jelly) in a 1:1 ratio. Ran-
domization lists were centrally computer generated with a
one-to-one allocation ratio in alternating blocks of four and
six by the Women and Infants pharmacy staff. According to
the randomization list, the pharmacy prepared identical
syringes containing 6 mL of the 2% lidocaine gel (120 mg)
or placebo gel labeled only with the study name and se-
quentially numbered. The study gels were indistinguishable
in appearance. Each participant was assigned a study ID
number corresponding with the order of recruitment into the
study. No identifiers of treatment group were placed on
subject data sheetsor medications, only the study number in
order of enrollment. Both subjects and providers were blind
to treatment assignment.
After randomization, we surveyed participants with a
preprocedure questionnaire assessing self-reported race,
ethnicity and primary language; self-assessment of pain
tolerance; ratings of anticipated and acceptable levels of pain
on the 0- to 100-mm visual analog scale (VAS); lactation
status; current contraception (if any); last menstrual period;
and any history of cervical conization (loop electrosurgical
excision procedure or cold knife cone). In order to measure
dysmenorrhea, women were also asked if their menses in the
last 3 months were associated with any pain (no pain, slight
pain, moderate pain, severe pain and very severe pain) or if
recently pregnant and if their menses in the 3 months prior to
pregnancy were associated with any pain. We administered
the State-Trait Anxiety Inventory for Adults to assess
baseline anxiety at the time of IUD insertion [21]. Obstetric
history was also obtained from subjects and the medical
record including date of last pregnancy, mode of past
deliveries and, if cesarean, whether scheduled (no labor) or
after a trial of labor, including the number of centimeters of
dilatation achieved. In addition, subject descriptors including
age, type of health insurance, height and weight were
abstracted from the medical record.
IUD insertions were performed by nurse practitioners,
obstetrics and gynecology residents and attending physicians
after standardized training on gel placement. After speculum
insertion, the study syringe was attached to a sterile 14-gauge
2-in. catheter, and a 3 mL of active or placebo gel was
extruded on to the anterior lip of the cervix. The catheter was
then introduced into the cervical canal up to but not through
the internal os, and the remaining gel in the syringe (3 mL)
was introduced. After waiting 3 min to allow for the onset of
action of the lidocaine gel [20], the tenaculum was placed.
Subjects were asked to report their pain level with the
tenaculum placement using the 0 to 100 VAS. The subject
was asked, “On this scale where 0 is no pain and 100 is the
worst pain ever, what was that like for you?” The VAS has
been validated by various studies to be an effective way to
measure acute pain intensity and has been used in past IUD
insertion studies [7,22,23]. IUD insertion was then per-
formed in the standard manner after sounding the uterus.
Subjects were again asked to rate their pain with IUD
insertion on the 0 to 100 VAS. We also measured the sub-
ject's pain rating with speculum insertion in a similar manner
to determine baseline pain tolerance. Other procedure
732 R.H. Allen et al. / Contraception 88 (2013) 730–736
characteristics collected during the IUD insertion were
procedure time (from tenaculum placement to removal of
inserter tube), insertion difficulty as rated by the clinician
(easy, average and difficult), timing of IUD insertion (6 to 12
weeks postpartum, 2 to 4 weeks postabortion or interval —
not related to pregnancy), uterine position, uterine size, type
of IUD, clinician performing the insertion and any insertion
complications. Lidocaine side effects were also queried after
the procedure such as ringing in the ears and numbness or
tingling around the mouth. Approximately 20 min post-
insertion, we measured pain levels on the VAS, side effects
such as nausea, vomiting and dizziness, and the acceptability
of the pain experienced during the IUD insertion. The
efficacy of blinding was measured by asking participants
what regimen they thought they received.
The primary outcome for this study was the IUD insertion
pain score. Assuming an alpha of 0.05, 80% power and a
standard deviation of 32 mm (based on a previous study in the
clinic), we planned to recruit 72 women per arm to be able to
detect a 15-mm mean difference between groups on the 0- to
Women asses
eligibili
n=272
Eligible f
participat
n=181
Excluded 
n=91
Declined
participation 
n=31
Randomi
n=150
Lidocaine gel
n=75
No IUD insertion
n=1
Protocol violation 
n=2
Analyzed
n=72
Fig. 1. Participan
100-mmVAS. Prior studies have shown a range for a clinically
significant difference in acute pain on the VAS from 13 to 16
mm [24–26]. We aimed to detect a 15-mm difference because
we considered this difference to be clinically significant and
wanted to minimize a potential Type II error. Adding 5% to
account for subject dropout, we planned to recruit a total of 150
women or 75 subjects per arm.
The statistical software package Statistical Analysis
System (SAS) version 9.2 (SAS Institute, Cary, NC, USA)
was used for all data analyses. Categorical variables were
compared by chi-square or Fisher's Exact Test. Continuous
variables were compared by t test or Wilcoxon rank sum test.
The association of lidocaine gel with pain on IUD insertion
was examined by multiple linear regression. Variables were
selected for inclusion if they were associated with pain on
IUD insertion with pb.1 in the univariable analysis.
Interactions between treatment group and predictors were
evaluated by an overall F test, followed by testing the
treatment effect within subgroups of the predictor by the
Dunnett method. Categories were combined for nominal and
sed for 
ty
or 
ion 
zed
Placebo gel
n=75
No IUD insertion
n=2
Analyzed
n=73
t flowchart.
Table 1
Sociodemographic characteristics of study participants by randomization group
Variable Placebo gel Lidocaine gel p
Total 73 (50.3) 72 (49.7)
Age (years)
Mean (SD) 25.2 (5.0) 26.2 (5.3) .2
Median (range) 24.0 (18.0–41.0) 25.0 (19.0–41.0)
Race/Ethnicity
Hispanic 23 (31.5) 23 (31.9) .7
Black 18 (24.7) 12 (16.7)
White 20 (27.4) 22 (30.6)
Other 12 (16.4) 15 (20.8)
Insurance
Medicaid 63 (86.3) 61 (84.7) .9
Private insurance/Health maintenance organization 8 (11.0) 8 (11.1)
Self-pay/Other 2 (2.7) 3 (4.2)
Body mass index
Mean (SD) 31.6 (8.1) 29.9 (7.8) .2
Gravida
Median (range) 2.0 (0.0–7.0) 2.0 (0.0–8.0) .08
Parity
Median (range) 1.0 (0.0–5.0) 2.0 (0.0–7.0) .2
Delivery history
Nulliparous 5 (6.8) 3 (4.2) .3
Cesarean only 17 (23.3) 11 (15.3)
Vaginal with or without cesarean 51 (69.9) 58 (80.6)
History of cervical conization
No 70 (95.9) 69 (95.8) 1.0
Yes 3 (4.1) 3 (4.2)
Currently breastfeeding
No 50 (68.5) 49 (68.1) 1.0
Yes 23 (31.5) 23 (31.9)
Timing of IUD insertion
Postpartum 46 (63.0) 43 (59.7) .7
Postabortion 2 (2.7) 4 (5.6)
Interval (gynecologic visit) 25 (34.2) 25 (34.7)
Uterine position
Midposition 16 (21.9) 11 (15.3) .5
Anteverted 39 (53.4) 45 (62.5)
Retroverted 18 (24.7) 16 (22.2)
Type of IUD
Cu-T380A 10 (13.7) 10 (13.9) 1.0
Levonorgestrel 63 (86.3) 62 (86.1)
State-anxiety T-score
Mean (SD) 49.0 (9.3) 48.2 (10.1) .6
Trait-anxiety T-score
Mean (SD) 50.5 (12.5) 50.0 (11.5) .8
How do you expect your pain to be (0 to 100)?
Mean (SD) 35.1 (19.8) 41.8 (23.3) .06
Median (range) 36.0 (0.0–79.0) 47.0 (0.0–96.0)
How much pain would you consider acceptable (0 to 100)?
Mean (SD) 49.8 (27.7) 48.8 (26.5) .8
Median (range) 50.0 (0.0–100.0) 48.5 (0.0–100.0)
How would you rate your pain tolerance?
Low 10 (13.7) 11 (15.3) .6
Moderate 34 (46.6) 27 (37.5)
High 29 (39.7) 34 (47.2)
On average, during the last 3 months, have your periods been associated with any pain?
None–Slight pain 35 (47.9) 45 (62.5) .1
Moderate pain 24 (32.9) 20 (27.8)
Severe–Very severe pain 14 (19.2) 7 (9.7)
Data are N (column %) unless otherwise noted.
Missing data no more than 2.1%. Percentages may not sum to 100 due to rounding.
733R.H. Allen et al. / Contraception 88 (2013) 730–736
able 3
ther procedure-related variables and complications by randomization group
ariable Placebo Lidocaine p
otal 73 (50.3) 72 (49.7)
734 R.H. Allen et al. / Contraception 88 (2013) 730–736
ordinal independent variables when necessary to avoid small
numbers. Residual plots were inspected for influential points
and heteroskedasticity. All p values presented were two
tailed, with pb.05 considered statistically significant.
otal procedure time(sec)
Median (range) 99.5
(52.0–1719.0)
111.0
(64.0–569.0)
.6
sertion difficulty
Easy 47 (66.2) 47 (67.1) .9
Average 22 (31.0) 20 (28.6)
Difficult 2 (2.8) 3 (4.3)
cute complications
None 72 (98.6) 71 (98.6) 1.0
Vasovagal reaction 0 (0.0) 1 (1.4)
Other 1 (1.4) 0 (0.0)
elayed complications at 12 weeks
None 70 (97.2) 70 (97.2) 1.0
Uterine infection 1 (1.4) 0 (0.0)
Partial IUD expulsion 1 (1.4) 1 (1.4)
Complete IUD expulsion 0 (0.0) 1 (1.4)
t its worst, how nauseous you have felt since the procedure?
No nausea 63 (86.3) 67 (94.4) .3
Mild nausea 5 (6.8) 3 (4.2)
Moderate nausea 2 (2.7) 1 (1.4)
Severe nausea 3 (4.1) 0 (0.0)
t its worst, how dizzy have you felt since you had the procedure?
Not dizzy 61 (83.6) 65 (91.5) .4
Mildly dizzy 7 (9.6) 4 (5.6)
Moderately dizzy 3 (4.1) 2 (2.8)
Severely dizzy 2 (2.7) 0 (0.0)
verall, how acceptable would you rate the amount of pain you had
during the IUD insertion today?
Completely acceptable 36 (49.3) 31 (44.3) .2
Mostly acceptable 19 (26.0) 21 (30.0)
Somewhat acceptable 11 (15.1) 17 (24.3)
Mostly unacceptable 6 (8.2) 1 (1.4)
Completely unacceptable 1 (1.4) 0 (0.0)
ata are N (column %) unless otherwise noted.
issing data no greater than 2.8%.
ercentages may not sum to 100 due to rounding.
3. Results
A total of 272 women seeking IUD insertion were
screened for study eligibility. Of these, 91 were ineligible, 31
declined to participate and 150 were enrolled (Fig. 1). Of
those ineligible, the most common reason was prior IUD use
(59%), followed by analgesic use in the past 12 h (21%), and
under age 18 (13%). Five participants were dropped from the
study for protocol violations leaving 145 for analysis: 3 who
did not have an IUD insertion, 1 who was later determined to
be ineligible because she had a prior IUD and 1 where only 2
mL of gel was used inadvertently. No participants withdrew
from the study. There were 37 different providers who
participated in the study. Grouping providers by experience,
63% were attending physicians or nurse practitioners, and
the remainder were resident physicians (PGY2 or above).
The two groups were similar in age, race/ethnicity, health
insurance and parity as well as procedure characteristics such
as timing of IUD insertion and type of IUD (Table 1). When
asked what level of pain was expected for the IUD insertion,
subjects in the lidocaine group reported a mean pain score of
41.8 (median: 47), and the placebo group reported a mean of
35.1 (median: 36) on a scale from 0 to 100 (p=.06). Baseline
anxiety, pain tolerance and history of dysmenorrhea were
similar between the two groups as well (Table 1).
The two groups had similar baseline pain scores with
speculum insertion (Table 2). The lidocaine group reported a
mean pain score with tenaculum placement of 37.5 (median:
39) compared to the placebo group of 41.6 (median: 37) (p=
Table 2
Pain scores by randomization group
Variable Placebo Lidocaine p
Total 73 (50.3) 72 (49.7)
Pain with speculum insertion
Mean (SD) 21.5 (23.7) 23.5 (23.8) .6
Median (range) 16.0 (0.0–100.0) 12.5 (0.0–71.0)
Interquartile range 2.0–32.0 3.5–39.5
Pain with tenaculum placement
Mean (SD) 41.6 (31.5) 37.5 (26.2) .4
Median (range) 37.0 (0.0–100.0) 39.0 (0.0–89.0)
Interquartile range 12.0–67.0 12.0–57.0
Pain during IUD insertion
Mean (SD) 36.7 (30.0) 35.2 (27.7) .8
Median (range) 36.0 (0.0–100.0) 34.0 (0.0–93.0)
Interquartile range 7.0–58.0 11.0–58.0
Pain 20 min postinsertion
Mean (SD) 21.4 (25.2) 20.6 (24.0) .8
Median (range) 10.5 (0.0–100.0) 10.0 (0.0–83.0)
Interquartile range 1.0–34.5 2.0–36.0
Missing data for postinsertion no greater than 2.1%.
T
O
V
T
T
In
A
D
A
A
O
D
M
P
.4). Similarly, pain with IUD insertion was no different with
a mean pain score of 35.2 (median: 34) in the lidocaine group
and 36.7 (median: 36) in the placebo group (p=.8) (Table 2).
Controlling for expected pain and baseline pain with
speculum insertion did not change the results. When the
analysis was repeated among only women who were nulli-
parous or only had cesarean sections without labor
(functionally nulliparous), there was still no difference in
pain scores between the lidocaine and placebo groups (data
not shown). There was no difference between the groups in
procedure difficulty as rated by the provider (Table 3). Only
one woman, who had a history of cesarean delivery only,
required cervical dilation for IUD placement. There were two
complications, one vasovagal reaction and 1 IUD that was
pulled out accidentally with scissors and had to be replaced.
No participants reported any systemic lidocaine side effects.
We also performed a multiple linear regression analysis to
identify predictors of pain with IUD insertion. After con-
trolling for randomization group, baseline speculum pain
score, delivery history, breastfeeding, insertion timing,
735R.H. Allen et al. / Contraception 88 (2013) 730–736
uterine position (mid, anteverted or retroverted) and history
of dysmenorrhea (severe–very severe pain during menses),
we found that nulliparity, interval IUD insertion and history
of dysmenorrhea were predictive of pain during IUD
insertion (data not shown). Increased pain was associated
with nulliparity [57.7, 95% confidence interval (CI): 38.7–
76.8], interval insertion (53.2, 95% CI: 43.3–63.1) and
dysmenorrhea (51.7, 95% CI: 38.0–65.3). A statistically
significant interaction between randomization group and
dysmenorrhea was observed (p=.01). Among patients with
severe to very severe pain during menses, lidocaine
treatment was associated with a 31.8 point (95% CI: 0.9–
62.8, p=.04) decrease in pain on the VAS compared to
placebo. There was no interaction between randomization
group and delivery history (nulliparity, cesarean section
[C/S] only or vaginal with or without C/S) (p=.5).
Postprocedure, there was no difference between the groups
in pain, nausea or dizziness (Table 3). The groups were similar
in terms of satisfaction with procedure pain. Delayed
complications were assessed for an additional 3 months
following the IUD insertion and were no different between the
two groups (Table 3). Finally, to assess the efficacy of blind-
ing, we asked participants to guess their treatment arm after
the IUD insertion. A chi-square test to assess a success of
blinding demonstrated no association between the partici-
pant's guess and actual treatment assignment (p=.8).
4. Discussion
We found that women who received 3 mL of 2% lidocaine
gel to the anterior lip of the cervix and 3 mL to the internal os
did not have reduced pain with tenaculum placement or IUD
insertion compared to placebo gel. This was true even among
women who were nulliparous or only had previous cesarean
sections without labor. These findings and our pain scores are
consistent with previous trials [10,19]. In the trial byMaguire et
al., with a greater proportion of nulliparous women than our
study, mean pain scores with IUD insertion were 50.9 in the
placebo arm and 51.0 in the 2% lidocaine gel arm. McNicholas
et al. reported median pain scores with placebo gel of six in
nulliparous women and five in parous women compared with
six in nulliparous women and four in parous women with the
2% lidocaine gel. In our study, we found that lidocaine may
have a beneficial effect in the subgroup of women with a
history of severe to very severe dysmenorrhea; however,
additional studies powered to evaluate this association are
needed. Our study confirmed that nulliparity, interval insertion
and history of dysmenorrhea were predictors of pain with IUD
insertion after adjusting for randomization group, baseline
speculum pain score, breastfeeding and uterine position. This is
similar to Maguire et al.'s analysis of predictors of pain except
that they found increased pain with the copper IUD compared
to the levonorgestrel intrauterine system, which we did not.
This study has several strengths. Since the initial pro-
mising study on 2% lidocaine gel for IUD insertion in 1996
[17], this study joins two other randomized controlled trials
in confirming lack of efficacy[10,19]. We utilized 6 mL of
gel as did the original study by Oloto et al. and waited 3
min to allow for onset of action. We also used a larger
amount of gel at the tenaculum site compared to other
studies (3 mL vs. 1 mL). In addition, we had an adequate
sample size to demonstrate a statistically significant
difference. Furthermore, we limited enrollment to women
who had no prior experience with IUD insertions and did
not use analgesics other than the study intervention.
Limitations to our study include the low numbers of nulli-
parous women who participated; there were 8 nulliparous
women (5.5%) compared to 137 multiparous women
(94.5%). This is a reflection of the population of women
who presented for care at the recruitment site. Nevertheless,
another randomized controlled trial of 2% lidocaine gel
with adequate numbers of nulliparous women reported no
difference in IUD insertion pain scores among that
population [18]. In addition, our study was conducted in
a teaching hospital, and 37 different providers participated.
The mean number of IUD insertions per study provider was
3.9 (SD: 5.0). Therefore, we were unable to ascertain
provider effect on IUD insertion pain. However, our results
can be generalized to providers with a variety of skill level,
and the subjects were equally randomized to residents and
faculty-level providers (nurse practitioners and attending
physicians). Furthermore, when analyzed, there was no
difference in pain score by experience level (resident vs.
faculty) among the two groups.
Promoting the use of IUDs is an important step towards
reducing the unintended pregnancy rate [3,24]. IUDs have
high satisfaction and continuation rates, despite the discom-
fort women may experience at the time of insertion [2].
While more research is needed into strategies to reduce pain
during IUD insertion, the more women are counseled on
what to expect during IUD insertion, they may be more
likely to opt for IUDs. Possible interventions to research in
the future include a 20-mL 1% lidocaine paracervical or
intracervical block and intrauterine lidocaine infusion.
References
[1] Mosher WD, Jones J. Use of contraception in the United States: 1982–
2008. Vital Health Stat 2010;23:1–4.
[2] Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D,
et al. Continuation and satisfaction of reversible contraception. Obstet
Gynecol 2012;117:1105–13.
[3] Peipert JF, Madden T, Allsworth JE, Secura GM. Preventing unin-
tended pregnancies by providing no-cost contraception. Obstet
Gynecol 2012;120(6):1291–7.
[4] Rubin SE, Winrob I. Urban female family medicine patients' percep-
tions about intrauterine contraception. J Womens Health (Larchmt)
2010;19:735–40.
[5] Goldstuck ND. Pain reduction during and after insertion of an
intrauterine contraceptive device. Adv Contracept 1987;3:25–36.
[6] Brockmeyer A, Kishen M, Webb A. Experience of IUD/IUS insertions
and clinical performance in nulliparous women–a pilot study. Eur J
Contracept Reprod Health Care 2008;13:248–54.
736 R.H. Allen et al. / Contraception 88 (2013) 730–736
[7] Hubacher D, Reyes V, Lillo S, Zepeda A, Chen PL, Croxatto H. Pain
from copper intrauterine device insertion: randomized trial of
prophylactic ibuprofen. Am J Obstet Gynecol 2006;195:1272–7.
[8] Chi IC, Galich LF, Tauber PF, Wilkens LR, Waszak CS, Siemens AJ,
et al. Severe pain at interval IUD insertion: a case–control analysis of
patient risk factors. Contraception 1986;34:483–95.
[9] Chi IC, Wilkens LR, Champion CB, Machemer RE, Rivera R.
Insertional pain and other IUD insertion-related rare events for
breastfeeding and non-breastfeeding women–a decade's experience
in developing countries. Adv Contracept 1989;5:101–19.
[10] Maguire K, Davis A, Rosario Tejeda L, Westhoff C. Intracervical
lidocaine gel for intrauterine device insertion: a randomized controlled
trial. Contraception 2012;86:214–9.
[11] Suhonen S, Haukkamaa M, Jakobsson T, Rauramo I. Clinical
performance of a levonorgestrel-releasing intrauterine system and
oral contraceptives in young nulliparous women: a comparative study.
Contraception 2004;69:407–12.
[12] Allen RH, Bartz D, Grimes DA, Hubacher D, O'Brien P. Interventions
for pain with intrauterine device insertion. Cochrane Database Syst
Rev 2009:CD007373.
[13] Chor J, Bregand-White J, Golobof A, Harwood B, Cowett A. Ibuprofen
prophylaxis for levonorgestrel-releasing intrauterine system insertion: a
randomized controlled trial. Contraception 2011;85:558–62.
[14] Saav I, Aronsson A, Marions L, Stephansson O, Gemzell-Danielsson
K. Cervical priming with sublingual misoprostol prior to insertion of an
intrauterine device in nulliparous women: a randomized controlled
trial. Hum Reprod 2007;22:2647–52.
[15] Dijkhuizen K, Dekkers OM, Holleboom CA, Groot de CJ,
Hellebrekers BW, van Roosmalen GJ, et al. Vaginal misoprostol
prior to insertion of an intrauterine device: an RCT. Hum Reprod
2011;26:323–9.
[16] Hollingworth B. Pain control during insertion of an intrauterine device.
Br J Fam Plann 1995;21:103–4.
[17] Oloto E, Bromham D, Murty J. Pain and discomfort perception at IUD
insertion-effect of short-duration, low-volume, intracervical applica-
tion of two percent lignocain gel (Instillagel)-a preliminary study. Br J
Fam Plann 1996;22:177–80.
[18] Mody SK, Kiley J, Rademaker A, Gawron L, Stika C, Hammond C.
Pain control for intrauterine device insertion: a randomized trial of 1%
lidocaine paracervical block. Contraception. 86:704-9.
[19] McNicholas CP, Madden T, Zhao Q, Secura G, Allsworth JE, Peipert
JF. Cervical lidocaine for IUD insertional pain: a randomized
controlled trial. Am J Obstet Gynecol 2012;207:384 e1-6.
[20] Hi-Tech Pharmacal Co. Lidocaine hydrochloride jelly product
information. In.
[21] Spielberger CD, Gorsuch RL, Lushene RE. State Trait Anxiety
Inventory. Tallahassee, Florida: Florida State University; 1967.
[22] Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale
for measurement of acute pain. Acad Emerg Med 2001;8:1153–7.
[23] Jensen MP, Miller L, Fisher LD. Assessment of pain during medical
procedures: a comparison of three scales. Clin J Pain 1998;14:
343–9.
[24] Allen RH, Goldberg AB, Grimes DA. Expanding access to intrauterine
contraception. Am J Obstet Gynecol 2009;201:456 e1-5.
	Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial
	1. Introduction
	2. Materials and methods
	3. Results
	4. Discussion
	References

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