Eutectic Mixture for Hemorrhoidectomy Postoperative

Phase 2

• Conditions: Hemorrhoidectomy
• Interventions: Drug: Eutectic mixture; Drug: placebo; Drug: lidocaine 2,5%; prilocaine 2,5%

• Registration Number: NCT00932542
• Lead Sponsor: Federal University of São Paulo

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 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-18
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Study Start: 2010-04
• Primary Completion: 2011-02
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-08
• Last Update Posted: 2012-10-10
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Eutectic mixture	Eutectic mixture	-
placebo	placebo	-
Medicaina	lidocaine 2,5%; prilocaine 2,5%	-

Primary Outcome Measures

Name	Time	Method
Reduction of pain evaluated by the analgesics demand.	Follow-up termination (1 month)

Secondary Outcome Measures

Name	Time	Method
Pain reduction by VAS	Follow-up termination (1 month)
Tolerability by the adverse events incidence	Follow-up termination (1 month)

Trial Locations

Locations (1)

Clínica Reis Neto; 🇧🇷 Campinas, São Paulo, Brazil