Back to resultsCOX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
Primary Purpose
Rupture of Anterior Cruciate Ligament
Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
parecoxib, valdecoxib, etoricoxib
Dexamethasone
parecoxib, valdecoxib, parecoxib and dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament focused on measuring Arthroscopic reconstruction, Anterior crucial ligament, Coxib, Dexamethasone
Eligibility Criteria
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
Sites / Locations
- Baerum Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
COXIB
Dexamethasone
COXIB and dexamethasone
Arm Description
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 8 mg iv
combination of coxib AND dexamethasone
Outcomes
Primary Outcome Measures
Postoperative VAS score at rest 24 hours after surgery
Secondary Outcome Measures
Cumulated opioid consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01361789
Brief Title
COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
Official Title
COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Asker & Baerum Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament
Keywords
Arthroscopic reconstruction, Anterior crucial ligament, Coxib, Dexamethasone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COXIB
Arm Type
Active Comparator
Arm Description
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
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
dexamethasone 8 mg iv
Arm Title
COXIB and dexamethasone
Arm Type
Active Comparator
Arm Description
combination of coxib AND dexamethasone
Intervention Type
Drug
Intervention Name(s)
parecoxib, valdecoxib, etoricoxib
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
8 mg IV
Intervention Type
Drug
Intervention Name(s)
parecoxib, valdecoxib, parecoxib and dexamethasone
Intervention Description
combination of both drugs
Primary Outcome Measure Information:
Title
Postoperative VAS score at rest 24 hours after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Cumulated opioid consumption
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vegard Dahl, PhD
Organizational Affiliation
Baerum Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich J Spreng, MD
Organizational Affiliation
Baerum Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baerum Hospital
City
Rud
ZIP/Postal Code
1309
Country
Norway
12. IPD Sharing Statement
Learn more about this trial
COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined
We'll reach out to this number within 24 hrs