By Rebecca H. Allen, MD, MPH
Assistant Professor, Department of Obstetrics and Gynecology, Warren Alpert Medical School of Brown University, Women and Infants’ Hospital, Providence, RI
Dr. Allen reports she is a Nexplanon trainer for Merck, a Liletta trainer for Actavis, and on the advisory board for Bayer, Actavis, and Vermillion.
SYNOPSIS: In this randomized, controlled trial, there was no difference in pain scores between the standard single-tooth tenaculum (mean 33/100) and the atraumatic vulsellum tenaculum (mean 35/100) (P = 0.58). The time to control bleeding at the tenaculum site differed with 1.1 minutes in the single-tooth tenaculum group and 0.4 minutes in the atraumatic vulsellum tenaculum group (P = 0.001).
SOURCE: Doty N, MacIsaac L. Effect of an atraumatic vulsellum versus a single-tooth tenaculum on pain perception during intrauterine device insertion: A randomized controlled trial. Contraception 2015;92:567-571.
This is a single-blind, randomized, controlled trial comparing the use of the atraumatic vulsellum tenaculum to the single-tooth tenaculum to grasp the cervix during intrauterine device (IUD) insertion at one center in New York. Eighty women without contraindications to IUD insertion were enrolled and randomized in a 1:1 ratio. Pain was measured at seven points during the procedure on a 0-100 mm visual analog scale: 1) prior to start, 2) speculum placement, 3) tenaculum placement, 4) uterine sounding, 5) IUD insertion, 6) speculum removal, and 7) 3 minutes post-procedure. IUDs were inserted by four experienced providers and two second-year OB/GYN residents. Forced coughing was performed at the time of tenaculum placement and the tenaculum was closed completely and “without audible clicks.”
Eighty women were randomized; however, three women in the atraumatic vulsellum group and one woman in the single-tooth tenaculum group did not receive the allocated intervention and were excluded from analysis. There was no difference between the two groups in terms of age, race, body mass index, IUD chosen, history of dysmenorrhea, preoperative anxiety score, or previous vaginal delivery. A similar number of women in each group had taken pre-procedure medications at home (17 ibuprofen, 2 opioids, 2 benzodiazepines, 1 acetaminophen, 1 diphenhydramine). There was no difference between the groups with pain at the time of tenaculum placement (33.3 single-tooth tenaculum vs 35.0 atraumatic vulsellum tenaculum, P = 0.58). Provider-reported ease of placement did not differ between the two groups (19 vs 19 out of a 0-100 mm visual analog scale). The length of time needed to control bleeding from the tenaculum site was longer in the single-tooth tenaculum group (1.1 minutes) compared to the atraumatic tenaculum group (0.4 minutes) (P = 0.001). Approximately 29% of women in the single-tooth tenaculum group required pressure and/or silver nitrate to control bleeding compared to 14% in the atraumatic vulsellum group (P = 0.1).
COMMENTARY
The vulsellum atraumatic tenaculum (also known as a Teale or Bierer tenaculum) has multiple small teeth that are not intended to puncture the cervical mucosa. It is similar to an Allis clamp but longer and angled in order to be used vaginally. The authors of this study report that the vulsellum atraumatic tenaculum was favored in their institution because providers believed it caused less pain and bleeding than the single-tooth tenaculum. Nevertheless, there were no data in the literature supporting this preference. Therefore, the authors undertook this simple trial that was powered to detect a 20 mm difference in pain scores on the 0-100 mm scale. While the authors did substantiate slightly longer procedure durations with the single-tooth tenaculum due to the time it took to control bleeding from tenaculum puncture sites, there was no difference in the pain experienced by the patient. It is admirable when our practices are examined in an evidence-based fashion, as we all tend to believe “our way” is the best way of doing a particular procedure.
The question of tenaculum type and pain experienced by women is a topic of interest to those of us who research interventions for pain control for gynecologic office procedures. 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. I find two points of the authors’ technique interesting. First, they described that both groups of patients were instructed to cough with tenaculum placement. While this common technique has been found to decrease pain with cervical biopsy,1 it has not been studied for tenaculum application. Second, they also reported closing the tenaculum completely without “audible clicks.” Presumably, avoiding the clicking sound lessens the patient’s anxiety. The decision to close the tenaculum completely, however, is different from what I have seen in the past for teaching IUD insertions. My experience is that most experts advise closing the tenaculum very slowly to only one ratchet as a technique to decrease pain.
At any rate, other studied interventions to reduce pain with tenaculum placement include topical and injected local anesthetics. 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.2 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). Nevertheless, the product label for 2% lidocaine gel states that onset of action occurs in 3 to 5 minutes when used on mucosal surfaces.3 While it is not surprising that the topical gel had no effect in this study, most providers are unwilling to wait a full 3 minutes for the gel to work, so this aspect of the study is more true to practice. To this end, Rapkin et al evaluated patient self-administration of 2% lidocaine gel vaginally 5 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).4 Because this technique does not require a speculum exam for gel application, it may be more acceptable to patients. It is unclear why the women in this study had a higher pain report with tenaculum placement than other studies.
In sum, reducing pain at time of tenaculum placement is a worthwhile endeavor. Injected lidocaine is effective in reducing pain with tenaculum placement and is convenient to perform when a paracervical block is planned. Topical agents typically are not effective unless a longer period of time elapses between administration and tenaculum placement. Doty et al examined yet another nuance of pain at time of tenaculum placement. I commend these authors for debunking the myth that atraumatic tenaculums or other similar instruments, such as ring forceps, are less painful when applied to the cervix than single-tooth tenaculums.
REFERENCES
- Schmid BC, et al. Forced coughing versus local anesthesia and pain associated with cervical biopsy: A randomized trial. Am J Obstet Gynecol 2008;199:641.e1-3.
- Goldthwaite LM, et al. Comparison of interventions for pain control with tenaculum placement: A randomized clinical trial. Contraception 2014;89:229-233.
- McGee DL. Local and topical anesthesia. In: Roberts JR, Hedges JR, eds. Clinical Procedures in Emergency Medicine. 5th ed. Philadelphia, PA: Saunders; 2010.
- Rapkin RB, et al. Self-administered lidocaine gel for intrauterine device insertion in nulliparous women: A randomized controlled trial. Obstet Gynecol 2014;123(Suppl 1):110S.
ABSTRACT & COMMENTARY: There was no difference in pain scores between the standard single-tooth tenaculum and the atraumatic vulsellum tenaculum.
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