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Eutectic Mixture for Hemorrhoidectomy Postoperative

NCT00932542 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2012-10-10

No results posted yet for this study

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).

Conditions

  • Hemorrhoidectomy

Interventions

DRUG

Eutectic mixture

The eutectic mixture of lidocaine + prilocaine + bupivacaine.

DRUG

placebo

placebo

DRUG

lidocaine 2,5%; prilocaine 2,5%

lidocaine 2,5%; prilocaine 2,5%

Sponsors & Collaborators

  • Cristália Produtos Químicos Farmacêuticos Ltda.

    collaborator INDUSTRY

  • Federal University of São Paulo

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-02-28
Completion
2012-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932542 on ClinicalTrials.gov