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Eutectic Mixture for Hemorrhoidectomy Postoperative (CRT054)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2012 by Joaquim Simoes Neto, Federal University of São Paulo.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932542
First Posted: July 3, 2009
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by (Responsible Party):
Joaquim Simoes Neto, Federal University of São Paulo
  Purpose
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).

Condition Intervention Phase
Hemorrhoidectomy Drug: Eutectic mixture Drug: placebo Drug: lidocaine 2,5%; prilocaine 2,5% Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: "Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"

Resource links provided by NLM:


Further study details as provided by Joaquim Simoes Neto, Federal University of São Paulo:

Primary Outcome Measures:
  • Reduction of pain evaluated by the analgesics demand. [ Time Frame: Follow-up termination (1 month) ]

Secondary Outcome Measures:
  • Pain reduction by VAS [ Time Frame: Follow-up termination (1 month) ]
  • Tolerability by the adverse events incidence [ Time Frame: Follow-up termination (1 month) ]

Enrollment: 144
Study Start Date: April 2010
Estimated Study Completion Date: November 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Eutectic mixture Drug: Eutectic mixture
The eutectic mixture of lidocaine + prilocaine + bupivacaine.
Placebo Comparator: placebo Drug: placebo
placebo
Active Comparator: Medicaina Drug: lidocaine 2,5%; prilocaine 2,5%
lidocaine 2,5%; prilocaine 2,5%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932542


Locations
Brazil
Clínica Reis Neto
Campinas, São Paulo, Brazil, 13010-112
Sponsors and Collaborators
Federal University of São Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
  More Information

Responsible Party: Joaquim Simoes Neto, Master Degree, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00932542     History of Changes
Other Study ID Numbers: CRT054
First Submitted: June 18, 2009
First Posted: July 3, 2009
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by Joaquim Simoes Neto, Federal University of São Paulo:
Hemorrhoidectomy

Additional relevant MeSH terms:
Lidocaine
Prilocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action