drugset / Trial / NCT00932542
Eutectic Mixture for Hemorrhoidectomy Postoperative
Phase 2/3
Unknown
144 enrolled
Federal University of São Paulo
Cristália Produtos Químicos Farmacêuticos Ltda. · collab
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2010-04
- Primary completion
- 2011-02
- Completion
- 2012-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupivacaine | Other / unclassified | — | Topical |
| Comparator | Lidocaine | Other / unclassified | — | Topical |
| Comparator | prilocaine | Small molecule | — | Topical |