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Eutectic Mixture for Hemorrhoidectomy Postoperative (CRT054)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by (Responsible Party):
Joaquim Simoes Neto, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00932542
First received: June 18, 2009
Last updated: October 8, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Hemorrhoids
U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Reduction of pain evaluated by the analgesics demand. [ Time Frame: Follow-up termination (1 month) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain reduction by VAS [ Time Frame: Follow-up termination (1 month) ] [ Designated as safety issue: No ]
  • Tolerability by the adverse events incidence [ Time Frame: Follow-up termination (1 month) ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Joaquim Simoes Neto, Master Degree, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT00932542     History of Changes
Other Study ID Numbers: CRT054
Study First Received: June 18, 2009
Last Updated: October 8, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:
Hemorrhoidectomy

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Prilocaine
Lidocaine
Anesthetics, Local
 Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013