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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06946121
Enrollment
100
Registered
2025-04-27
Start date
2024-09-30
Completion date
2025-04-12
Last updated
2025-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy

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.

Interventions

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

DRUGSaline

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain scoreat time of hysteroscopy and 15 minutes after itusing visual analogue scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026