OBJECTIVE: To compare the visual analog scale (VAS) score for pain and assess patient satisfaction and complications in women receiving intrauterine anesthesia with those receiving placebo during hysteroscopic-guided biopsy.
METHODS: The study was conducted in a tertiary care hospital over 17 months, from August 2021 to December 2022. One hundred twenty-six women scheduled for outpatient hysteroscopy-guided biopsy were included in this study and randomized either to the lidocaine (2% 5-mL solution) group or placebo group (63 individuals each). The study adopted a novel approach of vaginoscopic hysteroscopy that employed an intrauterine insemination catheter insertion and administered 2% (5 mL) lidocaine to the lidocaine group or saline (5 mL) to the placebo group. Pain scoring was carried out using the VAS scoring scale at hysteroscope insertion, during hysteroscopic-guided biopsy and after 10 minutes, 30 minutes, and 60 minutes of biopsy. Patient satisfaction level was assessed using the Likert scale. The primary objective was to compare the VAS score for pain between the groups during hysteroscopic-guided biopsy. Power analysis was performed in OpenEpi v3.01 software, using the log-transformed mean difference and standard deviation of the primary outcome (VAS score) of the study groups.
RESULTS: The median [interquartile range] VAS pain scores during hysteroscopic-guided biopsy were significantly higher in the placebo group (5 [5-6]) compared with the anesthesia group (4 [3-5]) ( P <.001). Similar results were noted during insertion of hysteroscope and at 10, 30, and 60 minutes after biopsy. Patients' satisfaction levels were significantly higher in the anesthesia group (30.2% were very satisfied) compared with the placebo group (1.6% were very satisfied) ( P <.001).
CONCLUSION: Intrauterine lidocaine instillation during vaginoscopic hysteroscopy-guided biopsy significantly reduced the pain during and after the procedure. It also improved the satisfaction of the patients after office hysteroscopy. No complications or side effects were associated with intrauterine lidocaine.
CLINICAL TRIAL REGISTRATION: Clinical Trials Registry India (CTRI), CTRI/2021/07/034679.
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
Although numerically the difference in pain measurement is not much, it may be important for women as reflected in the measurement of satisfaction and without expected side effects. I do not understand how have a result of an area under the ROC curve above one (Table 3).
, McMaster University