NCT00932542

Eutectic Mixture for Hemorrhoidectomy Postoperative

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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%

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-02-01
• Completion: 2012-11-01
• First posted: 2009-07-03
• Last updated: 2012-10-10

Locations

1 site across 1 country: Brazil