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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02185924
• Other study ID #: S-138/15-06-10
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 2, 2014
• Last updated: July 7, 2014
• Start date: January 2009
• Est. completion date: February 2014

Study information

• Verified date: July 2014
• Source: Asklepieion Voulas General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB

Intervention

Drug:
• Parecoxib

• CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%

• N/S 0.9%

Locations

Country	Name	City	State
Greece	Department of Anaesthesia Asklepeion Voulas General Hospital	Voula Athens

Sponsors (1)

Lead Sponsor	Collaborator
Asklepieion Voulas General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

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