NCT00932542

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2009

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

June 18, 2009

Last Update Submit

October 8, 2012

Conditions

Hemorrhoidectomy

Keywords

Hemorrhoidectomy

Outcome Measures

Primary Outcomes (1)

  • Reduction of pain evaluated by the analgesics demand.

    Follow-up termination (1 month)

Secondary Outcomes (2)

  • Pain reduction by VAS

    Follow-up termination (1 month)

  • Tolerability by the adverse events incidence

    Follow-up termination (1 month)

Study Arms (3)

Eutectic mixture

EXPERIMENTAL
Drug: Eutectic mixture

placebo

PLACEBO COMPARATOR
Drug: placebo

Medicaina

ACTIVE COMPARATOR
Drug: lidocaine 2,5%; prilocaine 2,5%

Interventions

Eutectic mixtureDRUG

The eutectic mixture of lidocaine + prilocaine + bupivacaine.

Eutectic mixture
placeboDRUG

placebo

placebo
lidocaine 2,5%; prilocaine 2,5%DRUG

lidocaine 2,5%; prilocaine 2,5%

Medicaina

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Reis Neto

Campinas, São Paulo, 13010-112, Brazil

Location

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

LidocaineAcetanilidesAnilidesAmidesOrganic ChemicalsPrilocaineAniline CompoundsAminesDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree

Study Record Dates

First Submitted

June 18, 2009

First Posted

July 3, 2009

Study Start

April 1, 2010

Primary Completion

February 1, 2011

Study Completion

November 1, 2012

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

BR(1)