POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB Clinical Trial
Official title:
COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY.
Verified date | July 2014 |
Source | Asklepieion Voulas General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
Combination of continuous femoral block with parEcoxib vs placebo. Investigation of morphine consumption, opioid sparing effects, VAS pain scores, haemodynamics, Anxierty scores, transfusion requirements , Range of motion and rehabilitation parameters between two groups
Status | Completed |
Enrollment | 90 |
Est. completion date | February 2014 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - PATIENTS ASA I-II UNDERGOING TOTAL KNEE ATRTHROPLASTY Exclusion Criteria: Exclusion criteria for both groups included: - Age younger than 40 years old or older than 80 years old - ASA > III - Obesity (>140 kg body weight) - Allergy to local anesthetics - History dependence on opioids - Contraindications for subarachnoid anesthesia or femoral block (coagulopathy, local infection, pre-existing neurological problems, patient refusal) - Contraindications to the administration of parecoxib - Severe hepatic or renal disease (serum creatinine = 1.7 mg/dl) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Greece | Department of Anaesthesia Asklepeion Voulas General Hospital | Voula Athens |
Lead Sponsor | Collaborator |
---|---|
Asklepieion Voulas General Hospital |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | RANGE OF MOTION, TRANSFUSION REQUIREMENTS, VAS SCORES POSTOPERATIVELY | AFTER 36 HOURS POSTOPERATIVELY | No | |
Other | MODIFIED BROMAGE SCALE | 36/h POSTOPEPATIVELY | No | |
Primary | MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS | 36/h POSTOPERATIVELY | No | |
Primary | VAS PAIN SCORES BETWEEN TWO GROUPS | 36/h POSTOPERATIVELY | No | |
Primary | HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS | During perioperative period | No | |
Secondary | ANXIETY LEVELS | ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY | 36 HOURS POSTOPERATIVELY | No |