Eutectic Mixture for Hemorrhoidectomy Postoperative (CRT054)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
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

June 18, 2009
October 8, 2012
April 2010
February 2011   (final data collection date for primary outcome measure)
Reduction of pain evaluated by the analgesics demand. [ Time Frame: Follow-up termination (1 month) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00932542 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Redução da dor pela EAV [ 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 ]
Not Provided
Not Provided
 
Eutectic Mixture for Hemorrhoidectomy Postoperative
"Topic Effects of Eutectic Mixture Use in Local Anesthetics on Hemorrhoidectomy Postoperative (Prospective Study, Randomized, Triple Blind, Placebo-controlled)"

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).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hemorrhoidectomy
  • Drug: Eutectic mixture
    The eutectic mixture of lidocaine + prilocaine + bupivacaine.
  • Drug: placebo
    placebo
  • Drug: lidocaine 2,5%; prilocaine 2,5%
    lidocaine 2,5%; prilocaine 2,5%
  • Experimental: Eutectic mixture
    Intervention: Drug: Eutectic mixture
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
  • Active Comparator: Medicaina
    Intervention: Drug: lidocaine 2,5%; prilocaine 2,5%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
144
November 2012
February 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00932542
CRT054
Yes
Joaquim Simoes Neto, Federal University of São Paulo
Federal University of São Paulo
Cristália Produtos Químicos Farmacêuticos Ltda.
Not Provided
Federal University of São Paulo
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP