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ACTIVE NOT RECRUITING
NCT07074626

Local Lidocaine Gel for Pain Management During

Sponsor: Suez University

View on ClinicalTrials.gov

Summary

Ultrasound is a very useful diagnostic tool in the obstetrics and gynecologic field. It is used to diagnose pelvic organs including the uterus, ovaries, tubes and endometrium, and can be used to evaluate gynecologic tumors regardless of their risk of malignant index. The types of pelvic sonography according to route include transvaginal sonography (TVS), transabdominal sonography (TAS), and transrectal sonography (TRS). Insertion of the probe into the vagina allows a very close and clear view of the pelvic organs, physicians have preferred TVS to TAS for accurate diagnosis of pelvic pathology .

Official title: Efficacy of Local Lidocaine Gel for Pain Management During Transrectal Sonography in Virgins With Suspected Pelvic Pathology, A Phase II Single Arm Interventional Study

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

45

Start Date

2025-06-01

Completion Date

2025-09-01

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

OTHER

transrectal ultrasound

A- Complete history was taking (personal, past, medical, surgical and family history) with careful attention to abdominal examination and suspected cause of pelvic pathology B- Through physical examination (general and abdominal examination). C- Investigations. * Trans-rectal ultrasound will be conducted to all the virgin patients as the standard US examination to detect the pelvic pathology * Patient anticipation for pain will be documented before the exam according to pain visual analogue scale (VAS) * Lidocaine gel will be used on the probe during TRU * The intensity of pain during trans-rectal US based on the pain visual analogue scale (0-10 ) points and the adverse events like extreme pain, inability to complete the examination and inability to detect the pathology will be reported.A Visual Analogue Scale (VAS) is one of the valided pain rating scales used for the first time in 1921 by Hayes and Patterson.

Locations (1)

faculty of medicine, Suez university

Suez, Suez Governorate, Egypt