NCT06946121

Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief During Office Hysteroscopy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Procedure: The procedure was done in the lithotomy position during the postmenstrual period. We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath \[TEKNO®, LIGHT XA 180, Germany\]. Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum). The hysteroscopy was gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. We used saline as the distension medium and the maximum pressure was set at 70 to 80 mm Hg by an automated hysteroscopic pump system (Hysteromat II, Karl Storz), which automatically measured intrauterine fluid pressure. In lidocaine group: we added 5 ml of lidocaine 2% to 500 ml of saline solution that was used as a distention medium. The uterine cavity and tubal ostia were systematically visualized. All procedures were done by an operator using the same equipment.

Detailed description

A written consent was taken from eligible women on admission after explaining the aim of the research, procedure, expected value, outcome, and possible adverse effects, with full details provided to them. They were informed that their participation in this study is voluntary and they may refuse to participate or withdraw from the study at any time. After fulfilling inclusion and exclusion criteria, patients were equally randomized by simple randomization with a 1:1 allocation ratio into two groups using computer-generated random numbers. The envelopes were kept in the office hysteroscopy room in a closed box. Each of the envelopes was taken out of the box sequentially according to the order of women attendance. Procedure: The procedure was done in the lithotomy position during the postmenstrual period. We used a 30° angle 2.9 mm rigid hysteroscopy with 3.8 mm diagnostic sheath \[TEKNO®, LIGHT XA 180, Germany\]. Vaginoscopic approach was used for insertion of the hysteroscopy in all cases (no use of speculum or tenaculum). The hysteroscopy was gently introduced into the uterine cavity after visualization of the cervix and identification of the external os. We used saline as the distension medium and the maximum pressure was set at 70 to 80 mm Hg by an automated hysteroscopic pump system (Hysteromat II, Karl Storz), which automatically measured intrauterine fluid pressure. In lidocaine group: we added 5 ml of lidocaine 2% to 500 ml of saline solution that was used as a distention medium. The uterine cavity and tubal ostia were systematically visualized. All procedures were done by an operator using the same equipment.

Conditions

• Hysteroscopy

Interventions

Type	Name	Description
DRUG	Lignocaine	50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.
DRUG	Saline	50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium.

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-02-15
• Completion: 2025-04-12
• First posted: 2025-04-27
• Last updated: 2025-04-27

Locations

1 site across 1 country: Egypt