HemorrhoidectomyPhase 2/3CRT054NCT00932542
Eutectic Mixture for Hemorrhoidectomy Postoperative
A Phase 2/3 study testing Eutectic mixture and lidocaine 2,5%; prilocaine 2,5% in people with Hemorrhoidectomy, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be operated and discharged at the same day in a day hospital clinic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemorrhoidectomy
- What is being tested?
- Eutectic mixture and lidocaine 2,5%; prilocaine 2,5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Nov 2012
- Phase
- Phase 2/3
- 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
Inclusion criteria: male and female patients, older than 18, having internal hemorrhoid disease grade III or IV with indication of elective surgery, anesthetic risk ASA 1 or 2; able to read and write.
Exclusion criteria: allergy or hypersensitivity to the mixture components, perianal fistulas, fissures, ulcers, infectious and inflammatory processes or tumors to the anal region, chronic diarrhea, megacolon or colonic anatomical deformities, hemorrhoidal thrombosis, gangrene or any condition that changes the indication from elective to urgent, previous surgery to anal-rectal region, history or clinical signs of diabetes mellitis type I or II, pregnancy, intense anxiety or important emotional disorder, participation in any clinical trial within the 3 months preceding the inclusion, investigator´s opinion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"
Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be operated and discharged at the same day in a day hospital clinic. During the fourteen days recovery period, they will apply the study medication to the anal region 4 times daily. The Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol demand will be tabulated. A rescue medication for analgesia will be provided (sodium diclofenac IM).
- Conditions
- Hemorrhoidectomy
- Being tested
- Eutectic mixture, placebo, lidocaine 2,5%; prilocaine 2,5%
- Keywords
- Hemorrhoidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eutectic mixtureDrug
The eutectic mixture of lidocaine + prilocaine + bupivacaine.
placeboDrug
placebo
lidocaine 2,5%; prilocaine 2,5%Drug
lidocaine 2,5%; prilocaine 2,5%
| Study group | Role | What they receive |
|---|---|---|
| Eutectic mixture | Experimental | Not described Receives: Drug: Eutectic mixture |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
| Medicaina | Active comparator | Not described Receives: Drug: lidocaine 2,5%; prilocaine 2,5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain evaluated by the analgesics demand.
Measured: Follow-up termination (1 month)
Secondary outcomes (2)
Pain reduction by VAS
Measured: Follow-up termination (1 month)
Tolerability by the adverse events incidence
Measured: Follow-up termination (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhoidectomyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Responsible party
- Principal investigator, Joaquim Simoes Neto, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932542
- Sponsor's protocol ID
- CRT054
- Acronym
- CRT054
- Status last verified
- Oct 2012
- First submitted
- 18 Jun 2009
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"
- ClinicalTrials.gov ID
- NCT00932542
- Acronym / sponsor ID
- CRT054 / CRT054
- Conditions
- Hemorrhoidectomy
- Keywords
- Hemorrhoidectomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Cristália Produtos Químicos Farmacêuticos Ltda.
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Nov 2012 (estimated)
- First posted
- 3 Jul 2009 (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.
Assess the efficacy and safety of the topic use of an eutectic mixture of local anesthetics for postoperative pain control of patients submitted to hemorrhoidectomy. Patients will be operated and discharged at the same day in a day hospital clinic. During the fourteen days recovery period, they will apply the study medication to the anal region 4 times daily. The Visual Analog Pain Scale (VAS) will be answered twice daily. Patients will also take 100 mg oral nimesulide twice daily and 50 mg tramadol on demand up to 4 times daily. The tramadol demand will be tabulated. A rescue medication for analgesia will be provided (sodium diclofenac IM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Eutectic mixture | Experimental | Drug: Eutectic mixture |
| placebo | Placebo comparator | Drug: placebo |
| Medicaina | Active comparator | Drug: lidocaine 2,5%; prilocaine 2,5% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Eutectic mixtureThe eutectic mixture of lidocaine + prilocaine + bupivacaine. | Drug | Eutectic mixture |
| placeboplacebo | Drug | placebo |
| lidocaine 2,5%; prilocaine 2,5%lidocaine 2,5%; prilocaine 2,5% | Drug | Medicaina |
Primary outcome
Reduction of pain evaluated by the analgesics demand.
Time frame: Follow-up termination (1 month)
2 secondary outcomes
Pain reduction by VAS
Time frame: Follow-up termination (1 month)
Tolerability by the adverse events incidence
Time frame: Follow-up termination (1 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Eutectic mixture and lidocaine 2,5%; prilocaine 2,5% in people with Hemorrhoidectomy, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 10 Oct 2012. 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 Brazil. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Results are not available in the source record.
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?
Reduction of pain evaluated by the analgesics demand. (time frame: Follow-up termination (1 month)). 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 10 Oct 2012.