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

NCT06946121 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-27

No results posted yet for this study

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.

Conditions

  • Hysteroscopy

Interventions

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-30
Primary Completion
2025-02-15
Completion
2025-04-12

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06946121 on ClinicalTrials.gov