A multi-center study on the use of lidocaine thermogel for pain control in outpatient operative hysteroscopy

Abstract

Objectives: This study aimed to explore the use of an anesthetic lidocaine thermogel in outpatient operative hysteroscopies. Specifically, it assessed the safety, tolerability, and ease of use of the gel, as well as its potential for pain reduction during the procedure.

Study design: This was a multicenter observational study conducted in 9 gynecological units between March 2023 and January 2024. The study included adult women scheduled for outpatient operative hysteroscopies, excluding those with hypersensitivity to the product or recent participation in other clinical studies. The target sample size was 60 to account for potential dropouts. Data collection was electronic, and SPSS was used for analysis. The study assessed visibility conditions, procedure duration, pain scores at different stages of the procedure, and adverse event frequency. Statistical analyses utilized descriptive statistics, Student's t-tests, Wilcoxon and Friedman tests, and Chi-Square or Fisher tests as appropriate. Binary logistic regression was applied to identify factors influencing gel volume.

Results: All 60 participants met the inclusion criteria. The mean age was 45.5 (SD 8.8) years, with a mean BMI of 27.0 (SD 5.6) kg/m². Medical histories were reported in 46.7% of participants, and 50% had undergone previous gynecological surgeries. Prior to the procedure, 51.8% of participants took analgesics. The average procedure duration was 13.9 (SD 15.1) minutes. Pain scores were collected at different stages of the procedure, with median VAS scores ranging from 0 to 5 out of 10. In 50% of cases, the quality of vision during the procedure was rated 9 or higher on a 10-point scale. The full recommended dose of thermogel was administered in 91.7% of cases. The mean gel volume used was 7.0 (SD 1.9) milliliters. Regression analysis showed that younger age and a history of abortions or childbirth were significantly associated with higher gel volume use.

Conclusions: The anesthetic thermogel demonstrated effectiveness in managing pain during outpatient operative hysteroscopies, with median pain scores ranging from 0 to 5 out of 10 across different stages of the procedure. The gel showed a favorable safety profile, with only 15% of participants reporting adverse effects, all of which were minor and resolved satisfactorily. The high rate of complete gel application (91.7% of cases) and positive physician feedback suggest good tolerability and ease of use. Further research is recommended to evaluate the gel's efficacy in other gynecological procedures and to optimize application protocols based on patient-specific factors such as age and reproductive history.

Keywords: Anesthetic thermogel; Gynecological procedures; Hysteroscopy; Lidocaine; Pain management.