HemorrhoidsPhase 3NCT02130830
Topical Anesthesia Versus Placebo to Decrease Pain in Rubber Band Ligation for Treatment of Internal Hemorrhoids
A Phase 3 study testing Topical 2,5% lidocaine + 2,5% prilocaine gel in people with Hemorrhoids and Pain, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoids, Pain
- What is being tested?
- Topical 2,5% lidocaine + 2,5% prilocaine gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChile
- Study dates
- May 2014to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic grade I - III hemorrhoidal disease
Who cannot join
- Chronic liver disease
- Use of class 3 antiarrythmics
- Coagulopathy
- Grade IV hemorrhoidal disease
- Inflammatory bowel disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Universidad Católica de Chile
Santiago, Santiago Metropolitan, 8330024
About this study
Official title: Topical Anesthesia Versus Placebo to Decrease Post Procedure Pain in Rubber Band Ligation for the Treatment of Grade I - III Symptomatic Internal Hemorrhoids. A Single Institution, Double Blinded, Placebo Controlled Trial.
Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before.
The investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.
- Conditions
- Hemorrhoids, Pain
- Being tested
- Topical 2,5% lidocaine + 2,5% prilocaine gel, Placebo
- Keywords
- hemorrhoids, Rubber band ligation, pain
- Medical subject headings
- Hemorrhoids, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical 2,5% lidocaine + 2,5% prilocaine gelDrug
The topical gel is administered in the anal canal at the moment of the anoscopy
PlaceboDrug
Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy
| Study group | Role | What they receive |
|---|---|---|
| Topical anesthesia | Experimental | Application of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure Receives: Drug: Topical 2,5% lidocaine + 2,5% prilocaine gel |
| Placebo | Placebo comparator | Application of placebo gel into the anal canal before the procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured in analog visual scale
Measured: up to 72 hours post procedure
Secondary outcomes (1)
Procedure morbidity
Measured: up to 30 days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gellona Jose, MD, Principal investigator, Pontificia Universidad Catolica de ChileBellolio Felipe, MD, Study chair, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130830
- Sponsor's protocol ID
- 14-038
- Status last verified
- Aug 2016
- First submitted
- 1 May 2014
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anesthesia Versus Placebo to Decrease Post Procedure Pain in Rubber Band Ligation for the Treatment of Grade I - III Symptomatic Internal Hemorrhoids. A Single Institution, Double Blinded, Placebo Controlled Trial.
- ClinicalTrials.gov ID
- NCT02130830
- Acronym / sponsor ID
- 14-038
- Conditions
- Hemorrhoids, Pain
- Keywords
- hemorrhoids, Rubber band ligation, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 5 May 2014 (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.
Rubber band ligation is a simple and effective procedure for the management of hemorrhoidal disease. However, 90% of patients have some degree of discomfort associated with the procedure and up to 40% develop clinically significant pain. Some studies have used local anesthesia to reduce pain with promising results, but the use of topical anesthesia has not been reported before.
The investigators hypothesize that the use of topical anesthesia before rubber band ligation significantly reduces post procedure pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical anesthesia | Experimental | Drug: Topical 2,5% lidocaine + 2,5% prilocaine gelApplication of topical 2,5% lidocaine + 2,5% prilocaine gel to the anal canal before the procedure |
| Placebo | Placebo comparator | Drug: PlaceboApplication of placebo gel into the anal canal before the procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic grade I - III hemorrhoidal disease
Key exclusion criteria (6 listed)
- Chronic liver disease
- Use of class 3 antiarrythmics
- Coagulopathy
- Grade IV hemorrhoidal disease
- Inflammatory bowel disease
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 |
|---|---|---|
| Topical 2,5% lidocaine + 2,5% prilocaine gelThe topical gel is administered in the anal canal at the moment of the anoscopy | Drug | Topical anesthesia |
| PlaceboPlacebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy | Drug | Placebo |
Primary outcome
Pain measured in analog visual scale
Time frame: up to 72 hours post procedure
1 secondary outcome
Procedure morbidity
Time frame: up to 30 days post procedure
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 2 Aug 2016.
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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.
Gellona Jose, MD principal investigator
Pontificia Universidad Catolica de Chile
Bellolio Felipe, MD study chair
Pontificia Universidad Catolica de Chile
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 Topical 2,5% lidocaine + 2,5% prilocaine gel in people with Hemorrhoids and Pain, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 6 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 2 Aug 2016. 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 Chile. 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 measured in analog visual scale (time frame: up to 72 hours post procedure). 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 2 Aug 2016.