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Completed

NCT Number: NCT01361789

COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined

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.

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Baerum Hospital

Rud, 1309, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parecoxib, valdecoxib, etoricoxib

Drug

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

Dexamethasone

Drug

8 mg IV

parecoxib, valdecoxib, parecoxib and dexamethasone

Drug

combination of both drugs

Primary outcomes

  1. Postoperative VAS score at rest 24 hours after surgery

    Time frame: 24 hours

Secondary outcomes

  1. Cumulated opioid consumption

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Asker & Baerum Hospital

Other

Registry information

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
May 27, 2011
Registry last updated
May 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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