Eutectic Mixture for Hemorrhoidectomy Postoperative

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Hemorrhoidectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No