Status:
UNKNOWN
Eutectic Mixture for Hemorrhoidectomy Postoperative
Lead Sponsor:
Federal University of São Paulo
Collaborating Sponsors:
Cristália Produtos Químicos Farmacêuticos Ltda.
Conditions:
Hemorrhoidectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 disc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT00932542
Start Date
April 1 2010
End Date
November 1 2012
Last Update
October 10 2012
Active Locations (1)
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1
Clínica Reis Neto
Campinas, São Paulo, Brazil, 13010-112