NCT00799149

Brief Summary

To determine that when administered as part of a multimodal analgesic regimen, use of the new COX-2 antagonist etoricoxib (120 mg/day, per os) is more effective in improving postoperative pain management after knee arthroscopy than gabapentin (1.2 g/day, per os).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 27, 2008

Completed
Last Updated

November 27, 2008

Status Verified

November 1, 2008

Enrollment Period

11 months

First QC Date

November 26, 2008

Last Update Submit

November 26, 2008

Conditions

Knee Arthroscopy

Keywords

Post-operative painKnee arthroscopyGabapentinEtoricoxibElective ambulatory knee arthroscopy

Outcome Measures

Primary Outcomes (1)

  • 1)Pain intensity (as assessed using a 100 visual analog scale) 2)Incidence of dipyrone usage

    96 hours post-operation

Secondary Outcomes (1)

  • The recovery of functional activity

    96 hours

Study Arms (3)

Gabapentin

ACTIVE COMPARATOR

Gabapentin (1200 mg) administered 30-90 min before the patient entered the operating room; Subsequent doses of Gabapentin (1200 mg)were administered on the mornings (08H00) of the first, second, and third postoperative days.

Drug: Gabapentin, Etoricoxib, Sugar pill

Etoricoxib

ACTIVE COMPARATOR

Etoricoxib (120 mg)administered 30-90 min before the patient entered the operating room; Subsequent doses of etoricoxib (120 mg)were administered on the mornings (08H00) of the first, second, and third postoperative days.

Drug: Gabapentin, Etoricoxib, Sugar pill

Sugar pill

PLACEBO COMPARATOR

Sugar pill administered 30-90 min before the patient entered the operating room. Subsequent doses of Sugar pill were administered on the mornings (08H00) of the first, second, and third postoperative days.

Drug: Gabapentin, Etoricoxib, Sugar pill

Interventions

Gabapentin, Etoricoxib, Sugar pillDRUG

Control (Sugar pill) or gabapentin (1200 mg) or etoricoxib (120 mg) administered 30-90 min before the patient entered the operating room with a sip of water. Subsequent doses of the oral study drugs were administered on the mornings (08H00) of the first, second, and third postoperative days. .

EtoricoxibGabapentinSugar pill

Eligibility Criteria

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

You may qualify if:

  • Elective ambulatory knee arthroscopy

You may not qualify if:

  • History of clinically-significant cardiovascular,pulmonary,hepatic,renal, neurologic, psychiatric or metabolic disease
  • Patients chronically receiving pain killers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

GabapentinEtoricoxibSugars

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsSulfonesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 26, 2008

First Posted

November 27, 2008

Study Start

June 1, 2006

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

November 27, 2008

Record last verified: 2008-11

Locations

IL(1)