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OpenTrials
Completed

NCT Number: NCT02185924

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

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

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Key information

Conditions

POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Anaesthesia Asklepeion Voulas General Hospital

Voula Athens, 16673, Greece

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Parecoxib

Drug

Other names: DYNASTAT

CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%

Drug

Other names: NAROPEINE

N/S 0.9%

Drug

Other names: PLACEBO

Primary outcomes

  1. MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS

    Time frame: 36/h POSTOPERATIVELY

  2. VAS PAIN SCORES BETWEEN TWO GROUPS

    Time frame: 36/h POSTOPERATIVELY

  3. HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS

    Time frame: During perioperative period

Secondary outcomes

  1. ANXIETY LEVELS

    Time frame: 36 HOURS POSTOPERATIVELY

    ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY

Other outcomes

  1. RANGE OF MOTION, TRANSFUSION REQUIREMENTS, VAS SCORES POSTOPERATIVELY

    Time frame: AFTER 36 HOURS POSTOPERATIVELY

  2. MODIFIED BROMAGE SCALE

    Time frame: 36/h POSTOPEPATIVELY

Sponsors and collaborators

Lead sponsor

Asklepieion Voulas General Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Jul 10, 2014
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.