Paracervical block efficacy in office hysteroscopic sterilization: a randomized controlled trial.

Abstract

OBJECTIVE:

To estimate the efficacy of paracervical block compared with saline for pain relief during office hysteroscopic sterilization.

METHODS:

This study was a randomized, placebo-controlled study of women desiring hysteroscopic sterilization. A paracervical block of 1% lidocaine or normal saline was administered before office hysteroscopic sterilization. Patients and investigators were blinded to assignments. A pre hoc power analysis determined that 40 women would be required per arm to detect a difference of 0.9 cm on a visual analog scale. Pain was recorded on a visual analog scale at multiple procedure time points. Individualized standardized pain scores were constructed by weighted reporting of objective and subjective sensation.

RESULTS:

A total of 103 consecutive women were eligible, and 80 women were randomized, with 40 per group. Thirty-seven (93%) in each group had successful placement. The lidocaine group showed significantly lower pain scores for tenaculum placement (mean+/-standard deviation: 0.97+/-1.28 compared with 3.00+/-2.41, P<.001) traversing the external cervical os (1.46+/-1.71 compared with 3.77+/-2.68, P<.001) and internal os (1.79+/-2.11 compared with 4.10+/-2.77, P<.001). There was no significant observed difference with device placement in tubal ostium (3.15+/-2.69 compared with 3.74+/-2.73, P=.33). Multivariable linear regression analysis demonstrated a relationship of pain to procedural time (P=.047) and to group assignment (P<.01).

CONCLUSION:

Paracervical block with 1% lidocaine provides effective pain relief for cervical manipulations during office hysteroscopic sterilization, but does not reduce the pain associated with upper uterine/tubal manipulation when placing the devices.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, www.clinicaltrials.gov, NCT00811187.

LEVEL OF EVIDENCE:

I.

• Authors: Scott Chudnoff, Mark Einstein, Mark Levie
• Journal: Obstetrics and gynecology (Obstet Gynecol) Vol. 115 Issue 1 Pg. 26-34 (Jan 2010) ISSN: 1873-233X [Electronic] United States
• PMID: 20027030 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Anesthetics, Local
• Lidocaine

Topics

• Adult
• Ambulatory Care
• Anesthesia, Obstetrical (methods)
• Anesthetics, Local (administration & dosage)
• Double-Blind Method
• Female
• Humans
• Hysteroscopy
• Lidocaine (administration & dosage)
• Multivariate Analysis
• Pain (prevention & control)
• Pain Measurement
• Sterilization, Reproductive
• Young Adult