Local Lidocaine Gel for Pain Management During

Suez University

Status: Active, not recruiting

Conditions: Ultrasound Diagnostics

Treatments: Other: transrectal ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT07074626

2

Details and patient eligibility

About

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 .

Full description

TVS is not acceptable because of a virginal introitus, agenesis of the vagina, or patient refusal of the introduction of a probe into the vagina, TRS may be a useful alternative tool for evaluating pelvic organs. The rectal administration of a local anesthetic, lidocaine gel, was recently proposed to reduce the pain of TRS-guided biopsy of the prostate. A similar result was also shown in a study evaluating the efficacy of lidocaine gel in rigid cystoscopy. However, data on the efficacy of lidocaine gel on providing the pain relief during TRS in gynecologic patients are lacking. Considering the clinical situation that many women have hesitated to undergo TRS because of concerns about pain, studies investigating methods for relieving pain during TRS are needed.

Recently, there are different type of scale, that are used for assessing pain but without any valid (accurate) and reliable (reproducible) instruments it is difficult to have real effect of treatment. The most commonly used pain scales are the Visual Analogue Scale (VAS), the Numerical Rating Scale (NRS) the Verbal Rating Scale (VRS) .

VAS is used in epidemiological and clinical research to calculate the intensity and frequency of a variety of clinical symptoms. In randomized controlled trials (RCT) and clinical trials (CT) VAS is frequently used to determine the effectiveness of treatment as an outcome measure. VAS is also very much popular in the gynecological area. In post operative pain assessment this scale is applied to measure pain. Moreover, after caesarean section the VAS is used to assessing pain

Enrollment: 45 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Virgins
• Patients with undiagnosed acute pelvic pain
• Patients with undiagnosed abnormal uterine bleeding
• Parents consent for patients less than 18 years

Exclusion criteria

• Medical history of allergy to lidocaine
• Chronic pelvic pain
• Chronic pain condition for which patients were taking daily pain medication
• Anorectal pathologies

Trial design

45 participants in 1 patient group

Group 1

Description:

A 45 virgin attending Suez university hospital gynecology outpatient clinic for collection of baseline data, including demographic information, medical history, body mass index (BMI).

Treatment:

Other: transrectal ultrasound