Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial

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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 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 [611]. 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 Contraception 88 (2013) 730 736 Source of funding: The Society of Family Planning Grant SFP4-4. ☆☆ Financial Disclosures: None. ClinicalTrials.gov Identifier: NCT01292447. Corresponding author. Tel.: + 1 401 274 1122x2724; fax: + 1 401 53 7684. E-mail address: [email protected] (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

Transcript of Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial

Contraception 88 (2013) 730–736

Original research article

Higher dose cervical 2% lidocaine gel for IUD insertion: a randomizedcontrolled trial☆,☆☆,★

Rebecca H. Allen⁎, Christina Raker, Vinita GoyalDepartment 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 obstetricsand 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 sociodemographicand clinical characteristics. Baseline pain scores with speculum insertion were no different between the two groups. The lidocaine groupreported 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 tenaculumplacement 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 theanterior lip of the cervix and at the internal os for 3 min did not reduce pain with tenaculum placement and IUD insertion compared toplacebo 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 inthe United States reported relying on the intrauterine device(IUD) [1]. Increased use of IUDs is desirable because themethod is a safe, highly effective, long-acting means ofcontraception that reduces unintended pregnancies [2,3].One barrier to IUDs for contraception is the fear of painduring insertion [4]. Components of the insertion procedurethat may cause pain include the tenaculum applied to thecervix to straighten the cervical canal and passing the uterinesound 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: [email protected] (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 maystimulate myometrial contractions causing pain [5].

Factors associated with pain during IUD insertion includenulliparity, lengthier time since last pregnancy or last menses,history of dysmenorrhea, anticipated pain, not currentlybreastfeeding and older age [6–11]. Studies have shown thatup to 21.3% of nulliparous women report severe pain duringIUD insertion, and nulliparous women report greater painduring IUD insertion than multiparous women [6,7,11].

There are no proven interventions for pain control duringIUD insertion [12]. Although widely used, both 400 mg and800 mg of ibuprofen prior to insertion are ineffective [7,13].Misoprostol also fails to provide decreased pain during IUDinsertion [14,15]. Topical 2% lidocaine gel on the cervix isanother option for pain control for IUD insertion. This isemployed in the UK but has not been adopted widely in theUS [16,17]. One early trial in 1996 showed decreased painwith 6 mL of 2% lidocaine gel; however, that study lacked

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proper blinding and allocation concealment [12,17]. Sincelidocaine gel does not require an injection, it may be pre-ferable to a paracervical block, which can be painful toadminister. In fact, in one study, a 10-mL 1% lidocaineparacervical block did not result in a statistically significantdecrease in pain with IUD insertion [18]. However, this samestudy did show a decrease in pain with tenaculum placementafter 2 mL of 1% lidocaine was injected into the anterior lipof the cervix. Two more recent randomized placebo-controlled trials have failed to find that 2% lidocaine gelapplied to the cervix decreased pain with IUD insertion. Thefirst trial used 1 mL of gel applied to the internal os of thecervix with a cotton swab for 1 min for a dose of 20 mgof lidocaine [10]. In the second trial, all subjects received800 mg of ibuprofen and 0.5–1 mL of gel on the anterior lipof the cervix as well as 2–3 mL of gel at the internal os for3 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 mLof 2% lidocaine at the anterior lip of the cervix and 3 mL inthe cervical canal for 3 min for pain control with tenaculumplacement and IUD insertion. This lidocaine dose, 120 mg,and application protocol are identical to the 1996 study byOloto et al. Our aim was to replicate this study in a properrandomized, placebo-controlled trial to determine the effec-tiveness of 2% lidocaine gel. We chose a 3-min waitingperiod to allow for the absorption of topical lidocaine gel.The product information for 2% lidocaine gel states that 3 to5 min is required for absorption [20]. We also sought todescribe participant satisfaction with pain control and anyside effects associated with 2% lidocaine gel.

2. Materials and methods

We conducted a randomized, double-blind, placebo-controlled trial at a university obstetrics and gynecologypractice in Providence, RI, from March 2011 to July 2012.The Women and Infants Hospital Institutional Review Boardgranted approval for the study protocol, and all patientsprovided written informed consent. English or Spanish-speaking women 18 to 49 years old requesting IUD insertionfor contraception or abnormal uterine bleeding wereapproached for participation. Inclusion criteria included noprior IUD use, more than 6 weeks postpartum or 2 weekspostabortion if recently pregnant, no analgesics or anxio-lytics in the previous 12 h and no misoprostol use prior toinsertion. Exclusion criteria included any contraindication toIUD 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 IUDor 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 andsix by the Women and Infants pharmacy staff. According tothe randomization list, the pharmacy prepared identicalsyringes 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 indistinguishablein appearance. Each participant was assigned a study IDnumber corresponding with the order of recruitment into thestudy. No identifiers of treatment group were placed onsubject data sheets or medications, only the study number inorder of enrollment. Both subjects and providers were blindto treatment assignment.

After randomization, we surveyed participants with apreprocedure questionnaire assessing self-reported race,ethnicity and primary language; self-assessment of paintolerance; ratings of anticipated and acceptable levels of painon the 0- to 100-mm visual analog scale (VAS); lactationstatus; current contraception (if any); last menstrual period;and any history of cervical conization (loop electrosurgicalexcision procedure or cold knife cone). In order to measuredysmenorrhea, women were also asked if their menses in thelast 3 months were associated with any pain (no pain, slightpain, moderate pain, severe pain and very severe pain) or ifrecently pregnant and if their menses in the 3 months prior topregnancy were associated with any pain. We administeredthe State-Trait Anxiety Inventory for Adults to assessbaseline anxiety at the time of IUD insertion [21]. Obstetrichistory was also obtained from subjects and the medicalrecord including date of last pregnancy, mode of pastdeliveries and, if cesarean, whether scheduled (no labor) orafter a trial of labor, including the number of centimeters ofdilatation achieved. In addition, subject descriptors includingage, type of health insurance, height and weight wereabstracted from the medical record.

IUD insertions were performed by nurse practitioners,obstetrics and gynecology residents and attending physiciansafter standardized training on gel placement. After speculuminsertion, the study syringe was attached to a sterile 14-gauge2-in. catheter, and a 3 mL of active or placebo gel wasextruded on to the anterior lip of the cervix. The catheter wasthen introduced into the cervical canal up to but not throughthe internal os, and the remaining gel in the syringe (3 mL)was introduced. After waiting 3 min to allow for the onset ofaction of the lidocaine gel [20], the tenaculum was placed.Subjects were asked to report their pain level with thetenaculum placement using the 0 to 100 VAS. The subjectwas asked, “On this scale where 0 is no pain and 100 is theworst pain ever, what was that like for you?” The VAS hasbeen validated by various studies to be an effective way tomeasure acute pain intensity and has been used in past IUDinsertion 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 IUDinsertion on the 0 to 100 VAS. We also measured the sub-ject's pain rating with speculum insertion in a similar mannerto determine baseline pain tolerance. Other procedure

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characteristics collected during the IUD insertion wereprocedure time (from tenaculum placement to removal ofinserter tube), insertion difficulty as rated by the clinician(easy, average and difficult), timing of IUD insertion (6 to 12weeks postpartum, 2 to 4 weeks postabortion or interval —not related to pregnancy), uterine position, uterine size, typeof IUD, clinician performing the insertion and any insertioncomplications. Lidocaine side effects were also queried afterthe procedure such as ringing in the ears and numbness ortingling around the mouth. Approximately 20 min post-insertion, we measured pain levels on the VAS, side effectssuch as nausea, vomiting and dizziness, and the acceptabilityof the pain experienced during the IUD insertion. Theefficacy of blinding was measured by asking participantswhat regimen they thought they received.

The primary outcome for this study was the IUD insertionpain score. Assuming an alpha of 0.05, 80% power and astandard deviation of 32 mm (based on a previous study in theclinic), we planned to recruit 72 women per arm to be able todetect a 15-mm mean difference between groups on the 0- to

Women asseseligibili

n=272

Eligible fparticipat

n=181

Excluded n=91

Declinedparticipation

n=31

Randomin=150

Lidocaine geln=75

No IUD insertionn=1

Protocol violation n=2

Analyzedn=72

Fig. 1. Participan

100-mmVAS. Prior studies have shown a range for a clinicallysignificant difference in acute pain on the VAS from 13 to 16mm [24–26]. We aimed to detect a 15-mm difference becausewe considered this difference to be clinically significant andwanted to minimize a potential Type II error. Adding 5% toaccount for subject dropout, we planned to recruit a total of 150women or 75 subjects per arm.

The statistical software package Statistical AnalysisSystem (SAS) version 9.2 (SAS Institute, Cary, NC, USA)was used for all data analyses. Categorical variables werecompared by chi-square or Fisher's Exact Test. Continuousvariables were compared by t test or Wilcoxon rank sum test.The association of lidocaine gel with pain on IUD insertionwas examined by multiple linear regression. Variables wereselected for inclusion if they were associated with pain onIUD insertion with pb.1 in the univariable analysis.Interactions between treatment group and predictors wereevaluated by an overall F test, followed by testing thetreatment effect within subgroups of the predictor by theDunnett method. Categories were combined for nominal and

sed for ty

or ion

zed

Placebo geln=75

No IUD insertionn=2

Analyzedn=73

t flowchart.

Table 1Sociodemographic 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) .2Median (range) 24.0 (18.0–41.0) 25.0 (19.0–41.0)

Race/EthnicityHispanic 23 (31.5) 23 (31.9) .7Black 18 (24.7) 12 (16.7)White 20 (27.4) 22 (30.6)Other 12 (16.4) 15 (20.8)

InsuranceMedicaid 63 (86.3) 61 (84.7) .9Private insurance/Health maintenance organization 8 (11.0) 8 (11.1)Self-pay/Other 2 (2.7) 3 (4.2)

Body mass indexMean (SD) 31.6 (8.1) 29.9 (7.8) .2

GravidaMedian (range) 2.0 (0.0–7.0) 2.0 (0.0–8.0) .08

ParityMedian (range) 1.0 (0.0–5.0) 2.0 (0.0–7.0) .2

Delivery historyNulliparous 5 (6.8) 3 (4.2) .3Cesarean only 17 (23.3) 11 (15.3)Vaginal with or without cesarean 51 (69.9) 58 (80.6)

History of cervical conizationNo 70 (95.9) 69 (95.8) 1.0Yes 3 (4.1) 3 (4.2)

Currently breastfeedingNo 50 (68.5) 49 (68.1) 1.0Yes 23 (31.5) 23 (31.9)

Timing of IUD insertionPostpartum 46 (63.0) 43 (59.7) .7Postabortion 2 (2.7) 4 (5.6)Interval (gynecologic visit) 25 (34.2) 25 (34.7)

Uterine positionMidposition 16 (21.9) 11 (15.3) .5Anteverted 39 (53.4) 45 (62.5)Retroverted 18 (24.7) 16 (22.2)

Type of IUDCu-T380A 10 (13.7) 10 (13.9) 1.0Levonorgestrel 63 (86.3) 62 (86.1)

State-anxiety T-scoreMean (SD) 49.0 (9.3) 48.2 (10.1) .6

Trait-anxiety T-scoreMean (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) .06Median (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) .8Median (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) .6Moderate 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) .1Moderate 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.

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able 3ther procedure-related variables and complications by randomization group

ariable Placebo Lidocaine p

otal 73 (50.3) 72 (49.7)

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ordinal independent variables when necessary to avoid smallnumbers. Residual plots were inspected for influential pointsand heteroskedasticity. All p values presented were twotailed, 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 difficultyEasy 47 (66.2) 47 (67.1) .9Average 22 (31.0) 20 (28.6)Difficult 2 (2.8) 3 (4.3)cute complicationsNone 72 (98.6) 71 (98.6) 1.0Vasovagal reaction 0 (0.0) 1 (1.4)Other 1 (1.4) 0 (0.0)elayed complications at 12 weeksNone 70 (97.2) 70 (97.2) 1.0Uterine 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) .3Mild 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) .4Mildly 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 hadduring the IUD insertion today?Completely acceptable 36 (49.3) 31 (44.3) .2Mostly 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 werescreened for study eligibility. Of these, 91 were ineligible, 31declined to participate and 150 were enrolled (Fig. 1). Ofthose ineligible, the most common reason was prior IUD use(59%), followed by analgesic use in the past 12 h (21%), andunder age 18 (13%). Five participants were dropped from thestudy for protocol violations leaving 145 for analysis: 3 whodid not have an IUD insertion, 1 who was later determined tobe ineligible because she had a prior IUD and 1 where only 2mL of gel was used inadvertently. No participants withdrewfrom the study. There were 37 different providers whoparticipated in the study. Grouping providers by experience,63% were attending physicians or nurse practitioners, andthe remainder were resident physicians (PGY2 or above).

The two groups were similar in age, race/ethnicity, healthinsurance and parity as well as procedure characteristics suchas timing of IUD insertion and type of IUD (Table 1). Whenasked what level of pain was expected for the IUD insertion,subjects in the lidocaine group reported a mean pain score of41.8 (median: 47), and the placebo group reported a mean of35.1 (median: 36) on a scale from 0 to 100 (p=.06). Baselineanxiety, pain tolerance and history of dysmenorrhea weresimilar between the two groups as well (Table 1).

The two groups had similar baseline pain scores withspeculum insertion (Table 2). The lidocaine group reported amean pain score with tenaculum placement of 37.5 (median:39) compared to the placebo group of 41.6 (median: 37) (p=

Table 2Pain scores by randomization group

Variable Placebo Lidocaine p

Total 73 (50.3) 72 (49.7)Pain with speculum insertionMean (SD) 21.5 (23.7) 23.5 (23.8) .6Median (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 placementMean (SD) 41.6 (31.5) 37.5 (26.2) .4Median (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 insertionMean (SD) 36.7 (30.0) 35.2 (27.7) .8Median (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 postinsertionMean (SD) 21.4 (25.2) 20.6 (24.0) .8Median (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%.

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.4). Similarly, pain with IUD insertion was no different witha mean pain score of 35.2 (median: 34) in the lidocaine groupand 36.7 (median: 36) in the placebo group (p=.8) (Table 2).Controlling for expected pain and baseline pain withspeculum insertion did not change the results. When theanalysis was repeated among only women who were nulli-parous or only had cesarean sections without labor(functionally nulliparous), there was still no difference inpain scores between the lidocaine and placebo groups (datanot shown). There was no difference between the groups inprocedure difficulty as rated by the provider (Table 3). Onlyone woman, who had a history of cesarean delivery only,required cervical dilation for IUD placement. There were twocomplications, one vasovagal reaction and 1 IUD that waspulled 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 toidentify predictors of pain with IUD insertion. After con-trolling for randomization group, baseline speculum painscore, delivery history, breastfeeding, insertion timing,

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uterine position (mid, anteverted or retroverted) and historyof dysmenorrhea (severe–very severe pain during menses),we found that nulliparity, interval IUD insertion and historyof dysmenorrhea were predictive of pain during IUDinsertion (data not shown). Increased pain was associatedwith nulliparity [57.7, 95% confidence interval (CI): 38.7–76.8], interval insertion (53.2, 95% CI: 43.3–63.1) anddysmenorrhea (51.7, 95% CI: 38.0–65.3). A statisticallysignificant interaction between randomization group anddysmenorrhea was observed (p=.01). Among patients withsevere to very severe pain during menses, lidocainetreatment was associated with a 31.8 point (95% CI: 0.9–62.8, p=.04) decrease in pain on the VAS compared toplacebo. There was no interaction between randomizationgroup 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 groupsin pain, nausea or dizziness (Table 3). The groups were similarin terms of satisfaction with procedure pain. Delayedcomplications were assessed for an additional 3 monthsfollowing the IUD insertion and were no different between thetwo groups (Table 3). Finally, to assess the efficacy of blind-ing, we asked participants to guess their treatment arm afterthe IUD insertion. A chi-square test to assess a success ofblinding 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% lidocainegel to the anterior lip of the cervix and 3 mL to the internal osdid not have reduced pain with tenaculum placement or IUDinsertion compared to placebo gel. This was true even amongwomen who were nulliparous or only had previous cesareansections without labor. These findings and our pain scores areconsistent with previous trials [10,19]. In the trial byMaguire etal., with a greater proportion of nulliparous women than ourstudy, mean pain scores with IUD insertion were 50.9 in theplacebo arm and 51.0 in the 2% lidocaine gel arm. McNicholaset al. reported median pain scores with placebo gel of six innulliparous women and five in parous women compared withsix in nulliparous women and four in parous women with the2% lidocaine gel. In our study, we found that lidocaine mayhave a beneficial effect in the subgroup of women with ahistory of severe to very severe dysmenorrhea; however,additional studies powered to evaluate this association areneeded. Our study confirmed that nulliparity, interval insertionand history of dysmenorrhea were predictors of pain with IUDinsertion after adjusting for randomization group, baselinespeculum pain score, breastfeeding and uterine position. This issimilar to Maguire et al.'s analysis of predictors of pain exceptthat they found increased pain with the copper IUD comparedto 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 trialsin confirming lack of efficacy [10,19]. We utilized 6 mL ofgel as did the original study by Oloto et al. and waited 3min to allow for onset of action. We also used a largeramount of gel at the tenaculum site compared to otherstudies (3 mL vs. 1 mL). In addition, we had an adequatesample size to demonstrate a statistically significantdifference. Furthermore, we limited enrollment to womenwho had no prior experience with IUD insertions and didnot use analgesics other than the study intervention.Limitations to our study include the low numbers of nulli-parous women who participated; there were 8 nulliparouswomen (5.5%) compared to 137 multiparous women(94.5%). This is a reflection of the population of womenwho presented for care at the recruitment site. Nevertheless,another randomized controlled trial of 2% lidocaine gelwith adequate numbers of nulliparous women reported nodifference in IUD insertion pain scores among thatpopulation [18]. In addition, our study was conducted ina teaching hospital, and 37 different providers participated.The mean number of IUD insertions per study provider was3.9 (SD: 5.0). Therefore, we were unable to ascertainprovider effect on IUD insertion pain. However, our resultscan be generalized to providers with a variety of skill level,and the subjects were equally randomized to residents andfaculty-level providers (nurse practitioners and attendingphysicians). Furthermore, when analyzed, there was nodifference in pain score by experience level (resident vs.faculty) among the two groups.

Promoting the use of IUDs is an important step towardsreducing the unintended pregnancy rate [3,24]. IUDs havehigh 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 painduring IUD insertion, the more women are counseled onwhat to expect during IUD insertion, they may be morelikely to opt for IUDs. Possible interventions to research inthe future include a 20-mL 1% lidocaine paracervical orintracervical block and intrauterine lidocaine infusion.

References

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