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