Eutectic Mixture for Hemorrhoidectomy Postoperative

Study Overview
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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).

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

Conditions
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Hemorrhoidectomy

Intervention / Treatment
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* Drug: Eutectic mixture
* Drug: placebo
* Drug: lidocaine 2,5%; prilocaine 2,5%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eutectic mixture<br> | Drug: Eutectic mixture<br>* The eutectic mixture of lidocaine + prilocaine + bupivacaine.<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo<br>|
| Active Comparator: Medicaina<br> | Drug: lidocaine 2,5%; prilocaine 2,5%<br>* lidocaine 2,5%; prilocaine 2,5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain evaluated by the analgesics demand. |  | Follow-up termination (1 month) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reduction by VAS |  | Follow-up termination (1 month) | 
| Tolerability by the adverse events incidence |  | Follow-up termination (1 month) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoidectomy