Clinical trial NCT06946121: Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief During Office Hysteroscopy
Official title: Comparison Between the Intrauterine Lidocaine and Warm Saline Distention Medium for Pain Relief During Office Hysteroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-27
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years old.

Indications of diagnostic office hysteroscopy as:

Suspicion of the intracavitary lesion. Abnormal uterine bleeding. Abnormal endometrial thickening. Postmenopausal bleeding. Mullerian congenital anomaly. Removal of foreign bodies. Undergoing the procedure to assess the endocervical canal, uterine cavity, and tubal ostia for infertility.

Exclusion Criteria:

* Patients with contra-indications of diagnostic hysteroscopy as:

Unable to exclude pregnancy Acute pelvic infection Active genital herpes Profuse bleeding at the time of the procedure. Any usage of analgesic agent on the day of the procedure. Failure of entry of the cervical canal requiring cervical dilatation. Any additional procedure during the procedure: polypectomy, biopsy and adhesiolysis.

Patient refusal to participate in the study.

Primary outcomes:
measure: Pain score
timeFrame: at time of hysteroscopy and 15 minutes after it
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Cairo University
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: