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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 cervix [5]. Immediately after placement, the IUD may


stimulate myometrial contractions causing pain [5].
As of 2008, only 5.5% of women using contraception in Factors associated with pain during IUD insertion include
the United States reported relying on the intrauterine device nulliparity, lengthier time since last pregnancy or last menses,
(IUD) [1]. Increased use of IUDs is desirable because the history of dysmenorrhea, anticipated pain, not currently
method is a safe, highly effective, long-acting means of breastfeeding and older age [6–11]. Studies have shown that
contraception that reduces unintended pregnancies [2,3]. up to 21.3% of nulliparous women report severe pain during
One barrier to IUDs for contraception is the fear of pain IUD insertion, and nulliparous women report greater pain
during insertion [4]. Components of the insertion procedure during IUD insertion than multiparous women [6,7,11].
that may cause pain include the tenaculum applied to the There are no proven interventions for pain control during
cervix to straighten the cervical canal and passing the uterine IUD insertion [12]. Although widely used, both 400 mg and
sound and IUD inserter tube through the internal os of the 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
Source of funding: The Society of Family Planning Grant SFP4-4.
☆☆ another option for pain control for IUD insertion. This is
Financial Disclosures: None.

ClinicalTrials.gov Identifier: NCT01292447. employed in the UK but has not been adopted widely in the
⁎ Corresponding author. Tel.: +1 401 274 1122x2724; fax: +1 401 53 7684. US [16,17]. One early trial in 1996 showed decreased pain
E-mail address: rhallen@wihri.org (R.H. Allen). with 6 mL of 2% lidocaine gel; however, that study lacked
0010-7824/$ – see front matter © 2013 Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.contraception.2013.07.009
R.H. Allen et al. / Contraception 88 (2013) 730–736 731

proper blinding and allocation concealment [12,17]. Since one-to-one allocation ratio in alternating blocks of four and
lidocaine gel does not require an injection, it may be pre- six by the Women and Infants pharmacy staff. According to
ferable to a paracervical block, which can be painful to the randomization list, the pharmacy prepared identical
administer. In fact, in one study, a 10-mL 1% lidocaine syringes containing 6 mL of the 2% lidocaine gel (120 mg)
paracervical block did not result in a statistically significant or placebo gel labeled only with the study name and se-
decrease in pain with IUD insertion [18]. However, this same quentially numbered. The study gels were indistinguishable
study did show a decrease in pain with tenaculum placement in appearance. Each participant was assigned a study ID
after 2 mL of 1% lidocaine was injected into the anterior lip number corresponding with the order of recruitment into the
of the cervix. Two more recent randomized placebo- study. No identifiers of treatment group were placed on
controlled trials have failed to find that 2% lidocaine gel subject data sheets or medications, only the study number in
applied to the cervix decreased pain with IUD insertion. The order of enrollment. Both subjects and providers were blind
first trial used 1 mL of gel applied to the internal os of the to treatment assignment.
cervix with a cotton swab for 1 min for a dose of 20 mg After randomization, we surveyed participants with a
of lidocaine [10]. In the second trial, all subjects received preprocedure questionnaire assessing self-reported race,
800 mg of ibuprofen and 0.5–1 mL of gel on the anterior lip ethnicity and primary language; self-assessment of pain
of the cervix as well as 2–3 mL of gel at the internal os for tolerance; ratings of anticipated and acceptable levels of pain
3 min for a dose of 50 mg to 80 mg of lidocaine [19]. on the 0- to 100-mm visual analog scale (VAS); lactation
The purpose of this study was to test the efficacy of 3 mL status; current contraception (if any); last menstrual period;
of 2% lidocaine at the anterior lip of the cervix and 3 mL in and any history of cervical conization (loop electrosurgical
the cervical canal for 3 min for pain control with tenaculum excision procedure or cold knife cone). In order to measure
placement and IUD insertion. This lidocaine dose, 120 mg, dysmenorrhea, women were also asked if their menses in the
and application protocol are identical to the 1996 study by last 3 months were associated with any pain (no pain, slight
Oloto et al. Our aim was to replicate this study in a proper pain, moderate pain, severe pain and very severe pain) or if
randomized, placebo-controlled trial to determine the effec- recently pregnant and if their menses in the 3 months prior to
tiveness of 2% lidocaine gel. We chose a 3-min waiting pregnancy were associated with any pain. We administered
period to allow for the absorption of topical lidocaine gel. the State-Trait Anxiety Inventory for Adults to assess
The product information for 2% lidocaine gel states that 3 to baseline anxiety at the time of IUD insertion [21]. Obstetric
5 min is required for absorption [20]. We also sought to history was also obtained from subjects and the medical
describe participant satisfaction with pain control and any record including date of last pregnancy, mode of past
side effects associated with 2% lidocaine gel. 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
2. Materials and methods age, type of health insurance, height and weight were
abstracted from the medical record.
We conducted a randomized, double-blind, placebo- IUD insertions were performed by nurse practitioners,
controlled trial at a university obstetrics and gynecology obstetrics and gynecology residents and attending physicians
practice in Providence, RI, from March 2011 to July 2012. after standardized training on gel placement. After speculum
The Women and Infants Hospital Institutional Review Board insertion, the study syringe was attached to a sterile 14-gauge
granted approval for the study protocol, and all patients 2-in. catheter, and a 3 mL of active or placebo gel was
provided written informed consent. English or Spanish- extruded on to the anterior lip of the cervix. The catheter was
speaking women 18 to 49 years old requesting IUD insertion then introduced into the cervical canal up to but not through
for contraception or abnormal uterine bleeding were the internal os, and the remaining gel in the syringe (3 mL)
approached for participation. Inclusion criteria included no was introduced. After waiting 3 min to allow for the onset of
prior IUD use, more than 6 weeks postpartum or 2 weeks action of the lidocaine gel [20], the tenaculum was placed.
postabortion if recently pregnant, no analgesics or anxio- Subjects were asked to report their pain level with the
lytics in the previous 12 h and no misoprostol use prior to tenaculum placement using the 0 to 100 VAS. The subject
insertion. Exclusion criteria included any contraindication to was asked, “On this scale where 0 is no pain and 100 is the
IUD placement, allergy to lidocaine or sensitivities to com- worst pain ever, what was that like for you?” The VAS has
ponents of the lidocaine or placebo gel and chronic narcotic, been validated by various studies to be an effective way to
benzodiazepine or barbiturate use within the past year. Sub- measure acute pain intensity and has been used in past IUD
jects chose the type of IUD desired, either the CuT380A IUD insertion studies [7,22,23]. IUD insertion was then per-
or the levonorgestrel IUD. formed in the standard manner after sounding the uterus.
After consent and study enrollment by study staff, par- Subjects were again asked to rate their pain with IUD
ticipants were randomized to one of two groups, 2% insertion on the 0 to 100 VAS. We also measured the sub-
lidocaine gel or placebo gel (KY Jelly) in a 1:1 ratio. Ran- ject's pain rating with speculum insertion in a similar manner
domization lists were centrally computer generated with a 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 100-mm VAS. Prior studies have shown a range for a clinically
procedure time (from tenaculum placement to removal of significant difference in acute pain on the VAS from 13 to 16
inserter tube), insertion difficulty as rated by the clinician mm [24–26]. We aimed to detect a 15-mm difference because
(easy, average and difficult), timing of IUD insertion (6 to 12 we considered this difference to be clinically significant and
weeks postpartum, 2 to 4 weeks postabortion or interval — wanted to minimize a potential Type II error. Adding 5% to
not related to pregnancy), uterine position, uterine size, type account for subject dropout, we planned to recruit a total of 150
of IUD, clinician performing the insertion and any insertion women or 75 subjects per arm.
complications. Lidocaine side effects were also queried after The statistical software package Statistical Analysis
the procedure such as ringing in the ears and numbness or System (SAS) version 9.2 (SAS Institute, Cary, NC, USA)
tingling around the mouth. Approximately 20 min post- was used for all data analyses. Categorical variables were
insertion, we measured pain levels on the VAS, side effects compared by chi-square or Fisher's Exact Test. Continuous
such as nausea, vomiting and dizziness, and the acceptability variables were compared by t test or Wilcoxon rank sum test.
of the pain experienced during the IUD insertion. The The association of lidocaine gel with pain on IUD insertion
efficacy of blinding was measured by asking participants was examined by multiple linear regression. Variables were
what regimen they thought they received. selected for inclusion if they were associated with pain on
The primary outcome for this study was the IUD insertion IUD insertion with pb.1 in the univariable analysis.
pain score. Assuming an alpha of 0.05, 80% power and a Interactions between treatment group and predictors were
standard deviation of 32 mm (based on a previous study in the evaluated by an overall F test, followed by testing the
clinic), we planned to recruit 72 women per arm to be able to treatment effect within subgroups of the predictor by the
detect a 15-mm mean difference between groups on the 0- to Dunnett method. Categories were combined for nominal and

Women assessed for


eligibility
n=272

Excluded
n=91

Eligible for
participation
n=181

Declined
participation
n=31

Randomized
n=150

Lidocaine gel Placebo gel


n=75 n=75

No IUD insertion
n=1 No IUD insertion
Protocol violation n=2
n=2

Analyzed Analyzed
n=72 n=73

Fig. 1. Participant flowchart.


R.H. Allen et al. / Contraception 88 (2013) 730–736 733

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.
734 R.H. Allen et al. / Contraception 88 (2013) 730–736

ordinal independent variables when necessary to avoid small Table 3


numbers. Residual plots were inspected for influential points Other procedure-related variables and complications by randomization group
and heteroskedasticity. All p values presented were two Variable Placebo Lidocaine p
tailed, with pb.05 considered statistically significant. Total 73 (50.3) 72 (49.7)
Total procedure time (sec)
Median (range) 99.5 111.0 .6
(52.0–1719.0) (64.0–569.0)
3. Results Insertion difficulty
Easy 47 (66.2) 47 (67.1) .9
A total of 272 women seeking IUD insertion were Average 22 (31.0) 20 (28.6)
Difficult 2 (2.8) 3 (4.3)
screened for study eligibility. Of these, 91 were ineligible, 31
Acute complications
declined to participate and 150 were enrolled (Fig. 1). Of None 72 (98.6) 71 (98.6) 1.0
those ineligible, the most common reason was prior IUD use Vasovagal reaction 0 (0.0) 1 (1.4)
(59%), followed by analgesic use in the past 12 h (21%), and Other 1 (1.4) 0 (0.0)
under age 18 (13%). Five participants were dropped from the Delayed complications at 12 weeks
None 70 (97.2) 70 (97.2) 1.0
study for protocol violations leaving 145 for analysis: 3 who
Uterine infection 1 (1.4) 0 (0.0)
did not have an IUD insertion, 1 who was later determined to Partial IUD expulsion 1 (1.4) 1 (1.4)
be ineligible because she had a prior IUD and 1 where only 2 Complete IUD expulsion 0 (0.0) 1 (1.4)
mL of gel was used inadvertently. No participants withdrew At its worst, how nauseous you have felt since the procedure?
from the study. There were 37 different providers who No nausea 63 (86.3) 67 (94.4) .3
Mild nausea 5 (6.8) 3 (4.2)
participated in the study. Grouping providers by experience,
Moderate nausea 2 (2.7) 1 (1.4)
63% were attending physicians or nurse practitioners, and Severe nausea 3 (4.1) 0 (0.0)
the remainder were resident physicians (PGY2 or above). At its worst, how dizzy have you felt since you had the procedure?
The two groups were similar in age, race/ethnicity, health Not dizzy 61 (83.6) 65 (91.5) .4
insurance and parity as well as procedure characteristics such Mildly dizzy 7 (9.6) 4 (5.6)
Moderately dizzy 3 (4.1) 2 (2.8)
as timing of IUD insertion and type of IUD (Table 1). When
Severely dizzy 2 (2.7) 0 (0.0)
asked what level of pain was expected for the IUD insertion, Overall, how acceptable would you rate the amount of pain you had
subjects in the lidocaine group reported a mean pain score of during the IUD insertion today?
41.8 (median: 47), and the placebo group reported a mean of Completely acceptable 36 (49.3) 31 (44.3) .2
35.1 (median: 36) on a scale from 0 to 100 (p=.06). Baseline Mostly acceptable 19 (26.0) 21 (30.0)
Somewhat acceptable 11 (15.1) 17 (24.3)
anxiety, pain tolerance and history of dysmenorrhea were
Mostly unacceptable 6 (8.2) 1 (1.4)
similar between the two groups as well (Table 1). Completely unacceptable 1 (1.4) 0 (0.0)
The two groups had similar baseline pain scores with
Data are N (column %) unless otherwise noted.
speculum insertion (Table 2). The lidocaine group reported a Missing data no greater than 2.8%.
mean pain score with tenaculum placement of 37.5 (median: Percentages may not sum to 100 due to rounding.
39) compared to the placebo group of 41.6 (median: 37) (p=

.4). Similarly, pain with IUD insertion was no different with


Table 2 a mean pain score of 35.2 (median: 34) in the lidocaine group
Pain scores by randomization group and 36.7 (median: 36) in the placebo group (p=.8) (Table 2).
Variable Placebo Lidocaine p Controlling for expected pain and baseline pain with
speculum insertion did not change the results. When the
Total 73 (50.3) 72 (49.7)
Pain with speculum insertion analysis was repeated among only women who were nulli-
Mean (SD) 21.5 (23.7) 23.5 (23.8) .6 parous or only had cesarean sections without labor
Median (range) 16.0 (0.0–100.0) 12.5 (0.0–71.0) (functionally nulliparous), there was still no difference in
Interquartile range 2.0–32.0 3.5–39.5 pain scores between the lidocaine and placebo groups (data
Pain with tenaculum placement
not shown). There was no difference between the groups in
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) procedure difficulty as rated by the provider (Table 3). Only
Interquartile range 12.0–67.0 12.0–57.0 one woman, who had a history of cesarean delivery only,
Pain during IUD insertion required cervical dilation for IUD placement. There were two
Mean (SD) 36.7 (30.0) 35.2 (27.7) .8 complications, one vasovagal reaction and 1 IUD that was
Median (range) 36.0 (0.0–100.0) 34.0 (0.0–93.0)
pulled out accidentally with scissors and had to be replaced.
Interquartile range 7.0–58.0 11.0–58.0
Pain 20 min postinsertion No participants reported any systemic lidocaine side effects.
Mean (SD) 21.4 (25.2) 20.6 (24.0) .8 We also performed a multiple linear regression analysis to
Median (range) 10.5 (0.0–100.0) 10.0 (0.0–83.0) identify predictors of pain with IUD insertion. After con-
Interquartile range 1.0–34.5 2.0–36.0 trolling for randomization group, baseline speculum pain
Missing data for postinsertion no greater than 2.1%. score, delivery history, breastfeeding, insertion timing,
R.H. Allen et al. / Contraception 88 (2013) 730–736 735

uterine position (mid, anteverted or retroverted) and history [17], this study joins two other randomized controlled trials
of dysmenorrhea (severe–very severe pain during menses), in confirming lack of efficacy [10,19]. We utilized 6 mL of
we found that nulliparity, interval IUD insertion and history gel as did the original study by Oloto et al. and waited 3
of dysmenorrhea were predictive of pain during IUD min to allow for onset of action. We also used a larger
insertion (data not shown). Increased pain was associated amount of gel at the tenaculum site compared to other
with nulliparity [57.7, 95% confidence interval (CI): 38.7– studies (3 mL vs. 1 mL). In addition, we had an adequate
76.8], interval insertion (53.2, 95% CI: 43.3–63.1) and sample size to demonstrate a statistically significant
dysmenorrhea (51.7, 95% CI: 38.0–65.3). A statistically difference. Furthermore, we limited enrollment to women
significant interaction between randomization group and who had no prior experience with IUD insertions and did
dysmenorrhea was observed (p=.01). Among patients with not use analgesics other than the study intervention.
severe to very severe pain during menses, lidocaine Limitations to our study include the low numbers of nulli-
treatment was associated with a 31.8 point (95% CI: 0.9– parous women who participated; there were 8 nulliparous
62.8, p=.04) decrease in pain on the VAS compared to women (5.5%) compared to 137 multiparous women
placebo. There was no interaction between randomization (94.5%). This is a reflection of the population of women
group and delivery history (nulliparity, cesarean section who presented for care at the recruitment site. Nevertheless,
[C/S] only or vaginal with or without C/S) (p=.5). another randomized controlled trial of 2% lidocaine gel
Postprocedure, there was no difference between the groups with adequate numbers of nulliparous women reported no
in pain, nausea or dizziness (Table 3). The groups were similar difference in IUD insertion pain scores among that
in terms of satisfaction with procedure pain. Delayed population [18]. In addition, our study was conducted in
complications were assessed for an additional 3 months a teaching hospital, and 37 different providers participated.
following the IUD insertion and were no different between the The mean number of IUD insertions per study provider was
two groups (Table 3). Finally, to assess the efficacy of blind- 3.9 (SD: 5.0). Therefore, we were unable to ascertain
ing, we asked participants to guess their treatment arm after provider effect on IUD insertion pain. However, our results
the IUD insertion. A chi-square test to assess a success of can be generalized to providers with a variety of skill level,
blinding demonstrated no association between the partici- and the subjects were equally randomized to residents and
pant's guess and actual treatment assignment (p=.8). faculty-level providers (nurse practitioners and attending
physicians). Furthermore, when analyzed, there was no
difference in pain score by experience level (resident vs.
4. Discussion faculty) among the two groups.
Promoting the use of IUDs is an important step towards
We found that women who received 3 mL of 2% lidocaine reducing the unintended pregnancy rate [3,24]. IUDs have
gel to the anterior lip of the cervix and 3 mL to the internal os high satisfaction and continuation rates, despite the discom-
did not have reduced pain with tenaculum placement or IUD fort women may experience at the time of insertion [2].
insertion compared to placebo gel. This was true even among While more research is needed into strategies to reduce pain
women who were nulliparous or only had previous cesarean during IUD insertion, the more women are counseled on
sections without labor. These findings and our pain scores are what to expect during IUD insertion, they may be more
consistent with previous trials [10,19]. In the trial by Maguire et likely to opt for IUDs. Possible interventions to research in
al., with a greater proportion of nulliparous women than our the future include a 20-mL 1% lidocaine paracervical or
study, mean pain scores with IUD insertion were 50.9 in the intracervical block and intrauterine lidocaine infusion.
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 References
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