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

COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY.

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 Overview

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

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Greece
  • Voula Athens, Greece, 16673
    • Department of Anaesthesia Asklepeion Voulas General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CONTINUOUS FEMORAL BLOCK AND PARECOXIB; Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib	Drug: Parecoxib; Other Names: DYNASTAT; Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%; Other Names: NAROPEINE
Placebo Comparator: CONTINUOUS FEMORAL BLOCK AND PLACEBO; Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9%	Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%; Other Names: NAROPEINE; Drug: N/S 0.9%; Other Names: PLACEBO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
ANXIETY LEVELS	ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY	36 HOURS POSTOPERATIVELY

Other Outcome Measures

Outcome Measure	Time Frame
RANGE OF MOTION, TRANSFUSION REQUIREMENTS, VAS SCORES POSTOPERATIVELY	AFTER 36 HOURS POSTOPERATIVELY
MODIFIED BROMAGE SCALE	36/h POSTOPEPATIVELY

Collaborators and Investigators

• Sponsor: Asklepieion Voulas General Hospital
• Investigators: Principal Investigator: DESPOINA SARRIDOU, SENIOR REGISTRAR, SENIOR CLINICAL FELLOW THE ROYAL BROMPTON AND HAREFIELD TRUST, SENIOR REGISTRAR IN ANAESTHESIA ASKLEPEION VOULAS

Publications and helpful links

General Publications

• Sarridou DG, Chalmouki G, Braoudaki M, Siafaka I, Asmatzi C, Vadalouka A. Parecoxib Possesses Anxiolytic Properties in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Clinical Study. Pain Ther. 2016 Jun;5(1):55-62. doi: 10.1007/s40122-016-0046-1. Epub 2016 Feb 9.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 7, 2014
• First Posted (Estimate): July 10, 2014

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 7, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: PARECOXIB; CONTINUOUS FEMORAL BLOCK
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anesthetics, Local; Cyclooxygenase 2 Inhibitors; Ropivacaine; Parecoxib
• Other Study ID Numbers: S-138/15-06-10