Local Lidocaine Gel for Pain Management During

NCT07074626 | Active Not Recruiting DMC

• 1 other identifier: 2
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Ultrasound Diagnostics

Keywords

transrectal ultrasound

Outcome Measures

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.

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

  3 months

Study Arms (1)

Group 1

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

Other: transrectal ultrasound

Interventions

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.

Group 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

virgins attending the clinic with suspected pelvic pathology

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suez University: lead

Study Sites (1)

faculty of medicine, Suez university

Suez, Suez Governorate, 43221, Egypt

Location

Related Publications (10)

• Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.

  PMID: 30211382 BACKGROUND

• Nam SH, Kim KH, Choi C, Nam SH, Song T, Lee KW. Lidocaine gel versus plain lubricating gel for pain reduction during transrectal sonography (LIPS): A randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 May;212:60-64. doi: 10.1016/j.ejogrb.2017.03.012. Epub 2017 Mar 11.

  PMID: 28342390 BACKGROUND

• Begum MR, Hossain MA. Validity and reliability of visual analogue scale (VAS) for pain measurement. Journal of Medical Case Reports and Reviews. 2019;2(11).

  BACKGROUND

• Stourac P, Kucharova E, Krikava I, Maly R, Kosinova M, Harazim H, Smekalova O, Bartikova I, Stoudek R, Janku P, Huser M, Wagnerova K, Haklova O, Hakl L, Schwarz D, Zelinkova H, Littnerova S, Jarkovsky J, Gal R, Sevcik P. Establishment and evaluation of a post caesarean acute pain service in a perinatological center:retrospective observational study. Ceska Gynekol. 2014 Nov;79(5):363-70.

  PMID: 25472454 BACKGROUND

• Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016.

  PMID: 21621130 BACKGROUND

• Goktug HN, Ozturk U, Sener NC, Tuygun C, Bakirtas H, Imamoglu MA. Do lubricants with 2% lidocaine gel have an effect on patient comfort in diagnostic cystoscopy? Adv Clin Exp Med. 2014 Jul-Aug;23(4):585-7. doi: 10.17219/acem/37229.

  PMID: 25166443 BACKGROUND

• Irani J, Fournier F, Bon D, Gremmo E, Dore B, Aubert J. Patient tolerance of transrectal ultrasound-guided biopsy of the prostate. Br J Urol. 1997 Apr;79(4):608-10. doi: 10.1046/j.1464-410x.1997.00120.x.

  PMID: 9126093 BACKGROUND

• Renfer LG, Vaccaro JA, Kiesling V. Digital-directed transrectal core biopsy with spring-loaded biopsy device (Biopty). Urology. 1991 Aug;38(2):161-2. doi: 10.1016/s0090-4295(05)80079-2. No abstract available.

  PMID: 1877135 BACKGROUND

• Qureshi IA, Ullah H, Akram MH, Ashfaq S, Nayyar S. Transvaginal versus transabdominal sonography in the evaluation of pelvic pathology. J Coll Physicians Surg Pak. 2004 Jul;14(7):390-3.

  PMID: 15279738 BACKGROUND

• Park JW, Hwang SO, Park JH, Lee BI, Lee JH, Kim KW, et al. Discrimination between Benign and Malignant Pelvic Masses Using the Risk of Malignancy Index 1. J Korean Soc Menopause. 2013;19:18-25.

  BACKGROUND

MeSH Terms

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ahmed ElSherbiny

  faculty of medicine, Suez university Suez, Suez, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 6, 2025
• First Posted: July 20, 2025
• Study Start: June 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)