Combination of Continuous Femoral Block and Intravenous Parecoxib For Postoperative Analgesia After Total Knee Arthroplasty

Phase 2

Completed

• Conditions: POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB
• Interventions: Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%; Drug: Parecoxib; Drug: N/S 0.9%

• Registration Number: NCT02185924
• Lead Sponsor: Asklepieion Voulas General Hospital

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2011-09
• Study Completion: 2014-02
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-07
• Last Update Submitted: 2014-07-07
• Study First Posted: 2014-07-10
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTINUOUS FEMORAL BLOCK AND PLACEBO	N/S 0.9%	Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%
CONTINUOUS FEMORAL BLOCK AND PLACEBO	CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%	Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%
CONTINUOUS FEMORAL BLOCK AND PARECOXIB	CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%	Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib
CONTINUOUS FEMORAL BLOCK AND PARECOXIB	Parecoxib	Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib

Primary Outcome Measures

Name	Time	Method
MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS	36/h POSTOPERATIVELY
VAS PAIN SCORES BETWEEN TWO GROUPS	36/h POSTOPERATIVELY
HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS	During perioperative period

Secondary Outcome Measures

Name	Time	Method
ANXIETY LEVELS	36 HOURS POSTOPERATIVELY	ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY

Trial Locations

Locations (1)

Department of Anaesthesia Asklepeion Voulas General Hospital; 🇬🇷 Voula Athens, Greece