Gynecologic DiseasesPhase 3NCT02567838
Lidocaine Gel During Transrectal Sonography
A Phase 3 study testing Lidocaine gel in people with Gynecologic Diseases, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (TRS) in gynecologic field. Read more about this study
- Who is it for?
- Ages 15 to 80 years, women only
- Conditions the study is for
- Gynecologic Diseases
- What is being tested?
- Lidocaine gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2015to Aug 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 15 to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All virgin women who were scheduled to undergo transrectal sonography invited to participate.
Who cannot join
- Allergy to lidocaine or other local anesthetics;
- Patients with a chronic pain condition for which they were taking daily pain medications of any kind.
- A bleeding diathesis and/or anticoagulant treatment;
- Underlying anal or rectal diseases such as symptomatic hemorrhoid, anal fissure, fistulae or anal stricture;
- An inability to rate a visual analogue scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: LIdocaine Gel Versus Plain Lubricating Gel for Pain Reduction During Transrectal Sonography (LIPS)
The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (TRS) in gynecologic field.
Read the detailed description
TRS is the common procedure to diagnose or exclude gynecologic disease in virgin women. This procedure can be associated with significant pain, both on insertion of the ultrasound probe as well as on manipulating the probe. The investigators evaluated a new technique for pain relief during TRS. In all, 80 consecutive subjects undergoing TRS at obstetric and gynecologic department were randomized to receive either lidocaine gel(Instillagel) or placebo(Aquagel) rectally prior to probe insertion. The pain encountered before, during, and after the procedure was graded by the patient on a 10-point visual analogue score. The gel-associated side effect was also evaluated by phone survey after 2 day of procedure. The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal gynecologic ultrasonography.
- Conditions
- Gynecologic Diseases
- Being tested
- Lidocaine gel, Placebo
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine gelDrug
Also called Instillagel
Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
PlaceboDrug
Also called Aquagel
Placebo (Aquagel) was administered rectally prior to probe insertion.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine gel | Experimental | Instillagel (2% lidocaine) was administered rectally prior to probe insertion. Receives: Drug: Lidocaine gel |
| Placebo | Placebo comparator | Placebo (Aquagel) was administered rectally prior to probe insertion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessed by a 10-point visual analogue score
Measured: the day of the procedure (transrectal sonography)
Secondary outcomes (1)
Number of participants with gel-associated side effect
Information on side effect was collected by phone survey
Measured: 2 days after the procedure (transrectal sonography)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseasesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taejong Song, Kangbuk Samsung Hospital
- Investigators
- Taejong Song, MD PhD, Principal investigator, Kangbuk Samsung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567838
- Sponsor's protocol ID
- 2015-08-022
- Status last verified
- Mar 2017
- First submitted
- 1 Oct 2015
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIdocaine Gel Versus Plain Lubricating Gel for Pain Reduction During Transrectal Sonography (LIPS)
- ClinicalTrials.gov ID
- NCT02567838
- Acronym / sponsor ID
- 2015-08-022
- Conditions
- Gynecologic Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 5 Oct 2015 (estimated)
- 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.
The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (TRS) in gynecologic field.
Detailed description
TRS is the common procedure to diagnose or exclude gynecologic disease in virgin women. This procedure can be associated with significant pain, both on insertion of the ultrasound probe as well as on manipulating the probe. The investigators evaluated a new technique for pain relief during TRS. In all, 80 consecutive subjects undergoing TRS at obstetric and gynecologic department were randomized to receive either lidocaine gel(Instillagel) or placebo(Aquagel) rectally prior to probe insertion. The pain encountered before, during, and after the procedure was graded by the patient on a 10-point visual analogue score. The gel-associated side effect was also evaluated by phone survey after 2 day of procedure. The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal gynecologic ultrasonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine gel | Experimental | Drug: Lidocaine gelInstillagel (2% lidocaine) was administered rectally prior to probe insertion. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Aquagel) was administered rectally prior to probe insertion. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All virgin women who were scheduled to undergo transrectal sonography invited to participate.
Key exclusion criteria (5 listed)
- Allergy to lidocaine or other local anesthetics;
- Patients with a chronic pain condition for which they were taking daily pain medications of any kind.
- A bleeding diathesis and/or anticoagulant treatment;
- Underlying anal or rectal diseases such as symptomatic hemorrhoid, anal fissure, fistulae or anal stricture;
- An inability to rate a visual analogue scale
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 |
|---|---|---|
| Lidocaine gelAlso: InstillagelInstillagel (2% lidocaine) was administered rectally prior to probe insertion. | Drug | Lidocaine gel |
| PlaceboAlso: AquagelPlacebo (Aquagel) was administered rectally prior to probe insertion. | Drug | Placebo |
Primary outcome
Pain assessed by a 10-point visual analogue score
Time frame: the day of the procedure (transrectal sonography)
1 secondary outcome
Number of participants with gel-associated side effect
Time frame: 2 days after the procedure (transrectal sonography)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- 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.
Taejong Song, MD PhD principal investigator
Kangbuk Samsung Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine gel in people with Gynecologic Diseases, run by Kangbuk Samsung Hospital at 1 site in South Korea.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 27 Mar 2017. 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 South Korea. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain assessed by a 10-point visual analogue score (time frame: the day of the procedure (transrectal sonography)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2017.