NCT01017380

Brief Summary

The aims of this study was to compare analgesic efficacy of preoperative administration of etoricoxib versus celecoxib for post-operative pain relief after arthroscopic anterior cruciate ligament reconstruction. One hundred and two patients diagnosed as anterior cruciate ligament injury will randomized into 3 groups using opaque envelope. Both patients and surgeon were blinded to the allocation. All of the patients will be operated by one orthopaedic surgeon under regional anesthesia. Each group will be given either etoricoxib 120 mg., celecoxib 400 mg., or placebo 1 hour prior to operative incision. Post-operative pain intensity, time to first dose of analgesic requirement and numbers of analgesic used for rescue pain control and adverse events will be recorded periodically to 48 hours after surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2008

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

November 17, 2009

Last Update Submit

November 19, 2009

Conditions

Keywords

preemptive analgesiacruciate ligament

Outcome Measures

Primary Outcomes (1)

  • VAS score

    6,12,24,48 hour postoperative

Secondary Outcomes (1)

  • number of analgesic used

    48 hour postoperative

Study Arms (1)

placebo

EXPERIMENTAL

identical placebo

Drug: CelecoxibDrug: etoricoxib

Interventions

celecoxib 400 mg 1 cap before surgery

placebo

120 mg 1 tab before surgery

placebo

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients with anterior cruciate ligament injury age 15-50 yr

You may not qualify if:

  • previous knee surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Songkla University

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Related Publications (1)

  • Boonriong T, Tangtrakulwanich B, Glabglay P, Nimmaanrat S. Comparing etoricoxib and celecoxib for preemptive analgesia for acute postoperative pain in patients undergoing arthroscopic anterior cruciate ligament reconstruction: a randomized controlled trial. BMC Musculoskelet Disord. 2010 Oct 25;11:246. doi: 10.1186/1471-2474-11-246.

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

CelecoxibEtoricoxib

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridines

Study Officials

  • Boonsin Tangtrakulwanich, MD.,Ph.D

    Faculty of Medicine, Prince of Songkla University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

November 20, 2009

Study Start

January 1, 2008

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations