COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01361789

Enrollment

Registered

2011-05-27

Start date

2004-01-31

Completion date

2009-12-31

Last updated

2011-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Arthroscopic reconstruction, Anterior crucial ligament, Coxib, Dexamethasone

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.

Interventions

DRUGparecoxib, valdecoxib, etoricoxib

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

DRUGDexamethasone

8 mg IV

DRUGparecoxib, valdecoxib, parecoxib and dexamethasone

combination of both drugs

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Postoperative VAS score at rest 24 hours after surgery	24 hours

Secondary

Measure	Time frame
Cumulated opioid consumption	24 hours

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026