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

NCT ID: NCT06946121

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-04-12

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.

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lignocaine group

50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.

Group Type: EXPERIMENTAL

Lignocaine

Intervention Type: DRUG

50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.

Saline group

50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium.

Interventions

Lignocaine

50 women undergoing diagnostic outpatient office hysteroscopy proceeded by infusions of intrauterine lidocaine 2% and normal saline at room temperature.

Intervention Type: DRUG

Saline

50 women undergoing diagnostic outpatient office hysteroscopy using warmed normal saline distention medium.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed M Maged, MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Kasr Alainy medical school

Cairo, , Egypt

Countries

Egypt

Other Identifiers

364

Identifier Type: -

Identifier Source: org_study_id