LAS VEGAS — Paracervical block decreases the pain associated with cervical manipulation, but has little effect on the pain associated with hysteroscopic placement of the Essure device for sterilization or on the technical success of the placement, a single-center randomized trial showed.
“The management of the pain should be individualized between the patient and the physician, and attention to technique and patient reassurance are key to successful in-office placement of Essure devices,” Dr. Scott Chudnoff said at the annual meeting of the AAGL.
Although several researchers have performed assessments of pain during hysteroscopy, as well as during the Essure procedure, “most of these studies have significant methodological flaws, or they focused on diagnostic hysteroscopy,” noted Dr. Chudnoff of the department of obstetrics and gynecology and women's health at Albert Einstein College of Medicine, New York. “None focusing on Essure were randomized, placebo-controlled studies.”
To determine if paracervical block at the time of hysteroscopic placement of the Essure device provides clinical pain relief, he and his associates randomized 40 women to receive 10 cc of 1% lidocaine, and another 40 to receive 10 cc of normal saline, as a paracervical injection prior to the start of the procedure. The 10-cc dose of lidocaine “is the amount we used in a pilot study and is the recommended dose to be used based on the clinical indications for lidocaine in a paracervical block,” Dr. Chudnoff said in a later interview.
Patients were asked to complete the 8-point Visual Analog Scale to assess pain during ketorolac (Toradol) injection and at the conclusion of the placement of the Essure device.
Patients also used the VAS to report the average level and the highest level of pain during the procedure.
Dr. Chudnoff reported that there were three unsuccessful placements in each group.
The average pain score for hysteroscope placement into the cervix was 4.5 in the saline group, compared with 2.6 in the lidocaine group, a difference that was statistically significant. Similar findings were noted for transversing the external orifice of the cervix uteri (3.8 for the saline group vs. 1.5 for the lidocaine group) and for transversing the internal orifice of the cervix uteri (4.1 vs. 1.8).
However, there were no significant differences between the saline group and the lidocaine group in the average pain scores for placement of the Essure device (3.7 vs. 3.2).
For the procedures, which were performed between March 2007 and March 2008, all patients also received 60 mg IM ketorolac in the buttocks before the procedure to reduce tubal spasm. The researchers placed the speculum into the vagina, prepped the area, injected 1 cc of lidocaine into the anterior lip of the cervix, and placed a single-tooth tenaculum on the anterior lip.
Patients received 5 cc of 1% lidocaine or saline injected at the 4 o'clock location on the cervix and 5 cc of 1% lidocaine or saline injected at the 7 o'clock location. The researchers allowed for a 3- to 5-minute rest period to permit the block to set before the introduction of the hysteroscope and subsequent placement of the Essure device.
All subjects and investigators were blinded to the treatment groups, and no errors in randomization occurred. The average age of the patients was 35 years, and 62% were Hispanic.
Dr. Chudnoff disclosed that one of his associates, Dr. Mark Levie, serves on the medical advisory board and is on the speakers bureau for Conceptus Inc., which developed the Essure procedure.