Eutectic Mixture for Hemorrhoidectomy Postoperative

Hemorrhoidectomy Clinical Trial

— CRT054  

Official title:

"Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00932542
• Other study ID #: CRT054
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: June 18, 2009
• Last updated: October 8, 2012
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 144
• Est. completion date: November 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoidectomy

Intervention

Drug:
• Eutectic mixture
The eutectic mixture of lidocaine + prilocaine + bupivacaine.
• placebo
placebo
• lidocaine 2,5%; prilocaine 2,5%
lidocaine 2,5%; prilocaine 2,5%

Locations

Country	Name	City	State
Brazil	Clínica Reis Neto	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Cristália Produtos Químicos Farmacêuticos Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of pain evaluated by the analgesics demand.		Follow-up termination (1 month)	No
Secondary	Pain reduction by VAS		Follow-up termination (1 month)	No
Secondary	Tolerability by the adverse events incidence		Follow-up termination (1 month)	Yes