Eutectic Mixture for Hemorrhoidectomy Postoperative
Information source: Federal University of São Paulo
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemorrhoidectomy
Intervention: Eutectic mixture (Drug); placebo (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: Federal University of São Paulo
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).
Clinical Details
Official title: "Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-Controlled)"
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Reduction of pain evaluated by the analgesics demand.
Secondary outcome: Pain reduction by VASTolerability by the adverse events incidence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: October 2009
Ending date: September 2010
Last updated: July 7, 2009
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