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By Rebecca H. Allen, MD, MPH
Associate Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants Hospital, Providence, RI
Dr. Allen reports she receives grant/research support from Bayer and is a consultant for Merck.
SYNOPSIS: In this randomized controlled trial, there was no difference in pain score with tenaculum placement between the slow method of application and coughing with application (median pain score 44 vs. 32, P = 0.16).
SOURCE: Lambert T, Truong T, Gray B. Pain perception with cervical tenaculum placement during intrauterine device insertion: A randomised controlled trial. BMJ Sex Reprod Health 2019 Oct. 30; doi: 10.1136/bmjsrh-2019-200376. [Online ahead of print].
This is a randomized, controlled trial conducted at Duke University from January 2017 to March 2017. Inclusion criteria included English-speaking adult women who were having an intrauterine device (IUD) inserted. Women were excluded only if they were having another procedure in addition to an IUD insertion. Sociodemographic and clinical variables were collected, including age, obstetric history, body mass index (BMI), Generalized Anxiety Disorder-7 (GAD7) anxiety screen score, and any history of chronic pain or narcotic use. Procedures were performed by obstetrics and gynecology residents or attending physicians. Subjects were randomized to either the slow method of tenaculum placement (tenaculum closed on anterior lip of the cervix to the first ratchet over a five-second period) or the cough method of tenaculum placement (the participant was asked to give one strong cough first, then was asked to cough a second time, and the tenaculum then was placed on the anterior lip of the cervix). The study was not blinded. The primary outcome was the pain measured on a 0 to 100 mm visual analog scale at the time of tenaculum placement. The study had 90% power to detect a 16 mm difference on the visual analog scale between groups.
A total of 66 women, with a median age of 26 years and 50% of whom were nulliparous, were randomized. The median pain score in the slow placement group was 44 (interquartile range [IQR] 21, 63) and the median pain score in the cough group was 32 (IQR 19, 54), which was not statistically different (P = 0.16). The anxiety level was found to be associated with pain scores. Women with no/mild anxiety reported pain scores of 29 (IQR 18, 55), and women with moderate/severe anxiety reported pain scores of 54 (IQR 32, 67). There was no difference in pain scores between nulliparous and multiparous women or those with a history of chronic pain compared to those without. Provider assessment of optimal grasp of the cervix also did not differ between the two groups.
It is commendable that the authors took on this study to determine whether the tenaculum placement technique affects pain scores. The question of tenaculum placement and pain experienced by women is a topic of interest to most gynecologists. In most procedures involving uterine instrumentation, a tenaculum is used for stabilization and traction of the cervix and to decrease the flexion of the uterus to ease passage of instruments into the endometrial cavity. Common techniques that many believe decrease pain with tenaculum placement are closing the tenaculum very slowly to only one ratchet or instructing the patient to cough while the tenaculum is placed. While coughing has been found to decrease pain with cervical biopsy,1 it has not been studied for tenaculum application. Previous studies comparing single-toothed and atraumatic tenaculums did not show any difference in pain with application.2,3
The authors did not find any difference in pain scores between the two groups. I wish they had compared these techniques to a third arm: placing the tenaculum on the anterior lip of the cervix quickly until it is completely closed. In this way, we would know whether ANY application technique reduces pain or whether the specific technique does not really matter. Other studied interventions to reduce pain with tenaculum placement include topical and injected local anesthetics; using a topical or local anesthetic does add a step to the procedure. A recent randomized, controlled trial among 70 women compared a 2 mL injection of 1% lidocaine and 1 mL of 2% lidocaine gel to the anterior lip of the cervix for tenaculum placement.4 The tenaculum was placed immediately after medication administration. The results showed that women who received the injection had significantly less pain at the time of tenaculum placement compared to women who received the topical gel (12.3 vs. 36.6 out of 100, P < 0.001). The product label for 2% lidocaine gel states that the onset of action occurs in three to five minutes when used on mucosal surfaces.5 Therefore, it is not surprising that the topical gel had no effect in this study. To this end, Rapkin and colleagues evaluated patient self-administration of 2% lidocaine gel vaginally five minutes prior to IUD insertion and found that mean pain scores for tenaculum placement were 32 in the lidocaine arm and 56 in the placebo group out of 100 (P = 0.030).6 Because this technique does not require a speculum exam for gel application, it may be more acceptable to patients, but the gel would have to be stocked in the office.
In sum, injected lidocaine is effective in reducing pain with tenaculum placement and is convenient to perform when a paracervical block is planned. Otherwise, the type of tenaculum and whether it is applied slowly or with a cough does not seem to make a difference for most patients in terms of pain experienced.
Financial Disclosure: OB/GYN Clinical Alert’s Editor Jeffrey T. Jensen, MD, MPH, reports that he is a consultant for and receives grant/ research support from ObstetRx, Bayer, Merck, and Sebela; he receives grant/research support from AbbVie, Mithra, and Daré Bioscience; and he is a consultant for CooperSurgical and the Population Council. Peer Reviewer Catherine Leclair, MD; Nurse Planner Andrea O’Donnell, FNP; Editorial Group Manager Leslie Coplin; Editor Jason Schneider; and Executive Editor Shelly Mark report no financial relationships relevant to this field of study.