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NCT Number: NCT07074626

Local Lidocaine Gel for Pain Management During

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 .

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Ultrasound Diagnostics

Sex eligibility

Female

Study type

Observational

Primary location

faculty of medicine, Suez university

Suez, Suez Governorate, 43221, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transrectal ultrasound

Other

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.

Primary outcomes

  1. Decrease the intensity of pain associated with lidocaine gel during trans-rectal ultrasound in compraison with patients exepectaions before the TRU examination by using Visual Analogue Scale, which is one of the valided pain rating scales.

    Time frame: 3 months

    A Visual Analogue Scale is one of the valided pain rating scales used for the first time in 1921 by Hayes and Patterson.

Sponsors and collaborators

Lead sponsor

Suez University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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