NCT01361789

Brief Summary

Recent studies on molar surgery have shown that a combination of a glucocorticoid and NSAID or COX-2 selective inhibitor gives better pain relief than either of the drugs used separately. The investigators group has also shown that adding dexamethasone on top of a regimen of paracetamol, NSAID and local anesthesia resulted in 45% painfree patients at rest after ambulatory breast cancer surgery. The goal of this study is to test the NSAID + glucocorticoid concept in ACl repair. The investigators want to evaluate whether a selective COX-2 selective inhibitor or a glucocorticoid or a combination of both drugs, as part of a multimodal analgesic regime, can provide improved pain relief and shorter hospital stay in patients undergoing outpatient ACL surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2004

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2011

Completed
Last Updated

May 27, 2011

Status Verified

May 1, 2011

Enrollment Period

5.9 years

First QC Date

May 26, 2011

Last Update Submit

May 26, 2011

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Arthroscopic reconstructionAnterior crucial ligamentCoxibDexamethasone

Outcome Measures

Primary Outcomes (1)

  • Postoperative VAS score at rest 24 hours after surgery

    24 hours

Secondary Outcomes (1)

  • Cumulated opioid consumption

    24 hours

Study Arms (3)

COXIB

ACTIVE COMPARATOR

40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery

Drug: parecoxib, valdecoxib, etoricoxib

Dexamethasone

ACTIVE COMPARATOR

dexamethasone 8 mg iv

Drug: Dexamethasone

COXIB and dexamethasone

ACTIVE COMPARATOR

combination of coxib AND dexamethasone

Drug: parecoxib, valdecoxib, parecoxib and dexamethasone

Interventions

parecoxib, valdecoxib, etoricoxibDRUG

40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery. After retraction of parecoxib from the market: Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery

COXIB
DexamethasoneDRUG

8 mg IV

Dexamethasone
parecoxib, valdecoxib, parecoxib and dexamethasoneDRUG

combination of both drugs

COXIB and dexamethasone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Arthroscopic reconstruction of the anterior crucial ligament (ACL)
  • At least 18 years old
  • ASA I + II

You may not qualify if:

  • Known renal impairment
  • Liver failure and/-or an asthmatic condition
  • Pregnancy
  • Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baerum Hospital

Rud, 1309, Norway

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

parecoxibvaldecoxibEtoricoxibDexamethasone

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Vegard Dahl, PhD

    Baerum Hospital

    PRINCIPAL INVESTIGATOR

  • Ulrich J Spreng, MD

    Baerum Hospital

    PRINCIPAL INVESTIGATOR

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

May 26, 2011

First Posted

May 27, 2011

Study Start

January 1, 2004

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 27, 2011

Record last verified: 2011-05

Locations

NO(1)