Eutectic Mixture for Hemorrhoidectomy Postoperative - Full Text View

Eutectic Mixture for Hemorrhoidectomy Postoperative (CRT054)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Federal University of São Paulo. Recruitment status was Recruiting

First Received on June 18, 2009. Last Updated on November 5, 2010 History of Changes

Sponsor:	Federal University of São Paulo
Collaborator:	Cristália Produtos Químicos Farmacêuticos Ltda.
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00932542

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 II Phase III

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:

Drug Information available for: Lidocaine Prilocaine Prilocaine hydrochloride

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 ]

Estimated Enrollment:	64
Study Start Date:	October 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	May 2010 (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	Recruiting
Campinas, São Paulo, Brazil, 13010-112
Contact: Joaquim Simões Neto, MD (19) 3252-5611 drjoaquimsimoes@clinicareisneto.com.br
Contact: Laura Credidio (19) 9196-7308
Principal Investigator: Joaquim Simões Neto, MD

Sponsors and Collaborators

Federal University of São Paulo

Cristália Produtos Químicos Farmacêuticos Ltda.

More Information

No publications provided

Responsible Party:	Joaquim Simoes Neto, Clinica Reis Neto
ClinicalTrials.gov Identifier:	NCT00932542 History of Changes
Other Study ID Numbers:	CRT054
Study First Received:	June 18, 2009
Last Updated:	November 5, 2010
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 February 09, 2012