Ultrasound DiagnosticsNCT07074626
Local Lidocaine Gel for Pain Management During
An observational study of Ultrasound Diagnostics, run by Suez University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ultrasound Diagnostics
- What is being tested?
- transrectal ultrasound
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: virgins attending the clinic with suspected pelvic pathology
Who may be able to join
- Virgins
- Patients with undiagnosed acute pelvic pain
- Patients with undiagnosed abnormal uterine bleeding
- Parents consent for patients less than 18 years
Who cannot join
- Medical history of allergy to lidocaine
- Chronic pelvic pain
- Chronic pain condition for which patients were taking daily pain medication
- Anorectal pathologies
Trial locations and contacts
1 site in 1 country.
About this study
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
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 .
Read the detailed 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
- Conditions
- Ultrasound Diagnostics
- Being tested
- transrectal ultrasound
- Keywords
- transrectal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transrectal ultrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: transrectal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Jun 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Ultrasound DiagnosticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sewidan, Suez University
- Investigators
- Ahmed ElSherbiny, Principal investigator, faculty of medicine, Suez university Suez, Suez, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074626
- Sponsor's protocol ID
- 2
- Status last verified
- Jul 2025
- First submitted
- 6 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30211382Nam 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.
PubMed 28342390Begum MR, Hossain MA. Validity and reliability of visual analogue scale (VAS) for pain measurement. Journal of Medical Case Reports and Reviews. 2019;2(11).
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.
PubMed 25472454Hjermstad 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.
PubMed 21621130Goktug 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.
PubMed 25166443Irani 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.
PubMed 9126093Renfer 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.
PubMed 1877135Qureshi 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.
PubMed 15279738Park 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07074626
- Acronym / sponsor ID
- 2
- Conditions
- Ultrasound Diagnostics
- Keywords
- transrectal ultrasound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Suez UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: transrectal ultrasoundA 45 virgin attending Suez university hospital gynecology outpatient clinic for collection of baseline data, including demographic information, medical history, body mass index (BMI). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- virgins attending the clinic with suspected pelvic pathology
Key inclusion criteria (4 listed)
- Virgins
- Patients with undiagnosed acute pelvic pain
- Patients with undiagnosed abnormal uterine bleeding
- Parents consent for patients less than 18 years
Key exclusion criteria (4 listed)
- Medical history of allergy to lidocaine
- Chronic pelvic pain
- Chronic pain condition for which patients were taking daily pain medication
- Anorectal pathologies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transrectal ultrasoundA- 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. | Other | Group 1 |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Background: PubMed 30211382Delgado 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.
- Background: PubMed 28342390Nam 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.
- BackgroundBegum 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: PubMed 25472454Stourac 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.
- Background: PubMed 21621130Hjermstad 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.
- Background: PubMed 25166443Goktug 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.
- Background: PubMed 9126093Irani 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.
- Background: PubMed 1877135Renfer 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.
- Background: PubMed 15279738Qureshi 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.
- BackgroundPark 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed ElSherbiny principal investigator
faculty of medicine, Suez university Suez, Suez, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound Diagnostics, run by Suez University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07074626, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.