EXECUTIVE SUMMARY

New research indicates that while self-administered vaginal lidocaine gel does not reduce pain with IUD insertion, it does decrease pain with tenaculum placement, and decreases the need for cervical dilation in nulliparous women from 34.5% to 3.3%.

  • IUD is painful for many women, particularly nulliparous women; studies have not demonstrated an effective strategy to lessen this discomfort. A 2015 analysis concluded that lidocaine 2% gel, most nonsteroidal anti-inflammatory drugs, and misoprostol for cervical ripening were not effective for reducing pain associated with insertion in nulliparous women.
  • While a paracervical block has been shown to be effective in other office-based transcervical procedures, its effectiveness in reducing IUD insertion pain is unclear.

Intrauterine device (IUD) insertion is painful for many women, particularly nulliparous women; studies have not demonstrated an effective strategy to lessen this discomfort.1 New research indicates that while self-administered vaginal lidocaine gel does not reduce pain with IUD insertion, it does decrease pain with tenaculum placement.2

In a randomized, double-blind, placebo-controlled trial, women self-administered 2% lidocaine or placebo vaginal gel five minutes before IUD insertion. The primary outcome was change in pain from baseline to IUD insertion on a 100-mm visual analog scale. Researchers also assessed pain after speculum insertion, tenaculum placement, uterine sounding, and five minutes after IUD insertion. Secondary outcomes included patient acceptability, ease of IUD insertion, and need for pain medication for up to seven days.

To allow the gel to fully work, researchers knew the gel would require at least five minutes for full absorption, explains lead author Rachel Rapkin, MD, MPH, assistant professor in department of obstetrics and gynecology at University of South Florida in Tampa. This timeframe would call for providers to either insert the speculum, apply the gel, remove the speculum, then insert it again for the IUD procedure, or leave the speculum in for the full five-minute period – both which are uncomfortable for patients, she notes.

“That is how I came up with the idea of self-inserted lidocaine gel,” says Rapkin. “It completely eliminated that need for either two speculum exams or a prolonged speculum exam, and also allowed women to have an active role in their IUD insertion, which is a good thing.”

Researchers randomized nulliparous women presenting for copper or progestin IUD placement at faculty and resident clinics at a U.S. center to place 2% lidocaine or placebo gel vaginally through use of an applicator 5 to15 minutes prior to IUD placement. A total of 58 participants were included in the trial; the mean age was 23-24.

Data indicate the mean change in pain with IUD placement was 61 mm and 69 mm with lidocaine and placebo, respectively (P=.06). The nulliparous women who were assigned lidocaine experienced less pain with tenaculum placement (32 vs. 56 mm) and were less likely to require cervical dilation (3.3% vs. 34.5%; P=0.002). Five minutes after the IUD placement procedure, about 66% of women in both groups indicated the level of discomfort experienced was acceptable, and more than 75% said they were satisfied with their placement procedure. Responses to these latter two outcomes were similar in the lidocaine and placebo groups.2\

Look for Options

Rapkin says she has seen many women who are potentially interested in receiving an IUD, but due to concerns about insertion pain, opt for another method.

“I didn’t want pain or fear of pain to be a barrier to women receiving this highly effective contraceptive,” states Rapkin. “I wanted to find another option for pain control, since nothing studied so far has shown to be effective.”

While self-administered gel did not alter the primary outcome of the study – pain with IUD placement – the apparent reduction in need for cervical dilation is promising and calls for future study, observes Andrew Kaunitz, MD, University of Florida Research Foundation Professor and Associate Chairman of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine-Jacksonville.

“The finding that among women allocated to placebo, pain with cervical tenaculum placement was similar in intensity to that associated with IUD placement itself underscores that it is not only the IUD placement that generates pain,” says Kaunitz. “For this reason, I use finer single-tooth tenacula designed for use with sonohysterograms, which appear to cause less pain and bleeding than conventional tenacula.”

Review the Research

A 2015 Cochrane Review analysis concluded that lidocaine 2% gel, most nonsteroidal anti-inflammatory drugs, and misoprostol for cervical ripening were not effective for reducing pain associated with insertion in nulliparous women.3 Nitroprusside before IUD insertion in nulliparous women also has been shown to be ineffective in decreasing pain or increasing ease of insertion.4

Data results in some trials indicate misoprostol causes nausea and abdominal cramping. Also, use of misoprostol requires a delay, which may be a barrier to access. For these reasons, routine misoprostol before IUD insertion in nulliparous women is not recommended, although it may be used with difficult insertions.1

While a paracervical block has been shown to be effective in other office-based transcervical procedures, its effectiveness in reducing IUD insertion pain is unclear. Two randomized studies compared a 10-mL 1% lidocaine paracervical block with no local anesthetic or saline injection before IUD insertion; one study included U.S. women who received the copper T380a and the five-year levonorgestrel-releasing IUD, while the other included Turkish women who received the copper T380a.5, 6 Both studies indicated a reduction in pain with tenaculum placement after injection of local anesthetic at the tenaculum site. In the U.S. study, there were no differences in IUD insertion pain between no treatment and lidocaine paracervical block. However, data in the Turkish study indicate pain scores were reduced with lidocaine paracervical block, but not with saline or no treatment5,6. In two placebo-controlled studies of IUD insertion, neither topical nor intracervical 2% lidocaine gel was found to reduce pain compared with placebo gel.7,8 A meta-analysis of several analgesic options concluded that lidocaine paracervical block reduces pain scores associated with tenaculum placement and IUD insertion.9

REFERENCES

  1. Committee Opinion No 672: Clinical challenges of long-acting reversible contraceptive methods. Obstet Gynecol 2016; 128(3):e69-77.
  2. Rapkin RB, Achilles SL, Schwarz EB, et al. Self-administered lidocaine gel for intrauterine device insertion in nulliparous women: a randomized controlled trial. Obstet Gynecol 2016; 128(3):621-628.
  3. Lopez LM, Bernholc A, Zeng Y, et al. Interventions for pain with intrauterine device insertion. Cochrane Database System Rev 2015; doi: 10.1002/14651858.
  4. Bednarek PH, Creinin MD, Reeves MF, et al. Immediate versus delayed IUD insertion after uterine aspiration. Post-Aspiration IUD Randomization (PAIR) Study Trial Group. N Engl J Med 2011; 364: 2208-2217.
  5. Mody SK, Kiley J, Rademaker A, et al. Pain control for intrauterine device insertion: A randomized trial of 1% lidocaine paracervical block. Contraception 2012; 86(6):704-709.
  6. Cirik DA, Taskin EA, Tuglu A, et al. Paracervical block with 1% lidocaine for pain control during intrauterine device insertion: a prospective, single-blinded, controlled study. Int J Reprod Contracept Obstet Gynecol 2013; 2:263-267.
  7. McNicholas CP, Madden T, Zhao Q, et al. Cervical lidocaine for IUD insertional pain: a randomized controlled trial. Am J Obstet Gynecol 2012; 207:384.e1-6.
  8. Maguire K, Davis A, Rosario Tejeda L, et al. Intracervical lidocaine gel for intrauterine device insertion: a randomized controlled trial. Contraception 2012; 86:214-219.
  9. Pergialiotis V, Vlachos DG, Protopappas A, et al. Analgesic options for placement of an intrauterine contraceptive: a meta-analysis. Eur J Contracept Reprod Health Care 2014; 19:149-160.