COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY.
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
CONTINUOUS FEMORAL BLOCK AND PARECOXIB
Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib
Intervention: Parecoxib (Drug)
CONTINUOUS FEMORAL BLOCK AND PARECOXIB
Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib
Intervention: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% (Drug)
CONTINUOUS FEMORAL BLOCK AND PLACEBO
Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%
Intervention: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% (Drug)
CONTINUOUS FEMORAL BLOCK AND PLACEBO
Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%
Intervention: N/S 0.9% (Drug)
Outcomes
Primary Outcomes
MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
Time Frame: 36/h POSTOPERATIVELY
VAS PAIN SCORES BETWEEN TWO GROUPS
Time Frame: 36/h POSTOPERATIVELY
HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS
Time Frame: During perioperative period
Secondary Outcomes
- ANXIETY LEVELS(36 HOURS POSTOPERATIVELY)
Investigators
Dr. Despoina Sarridou
ANAESTHESIOLOGIST
Asklepieion Voulas General Hospital