|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT02185924 |
|
Date of registration:
|
02/07/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Combination of Continuous Femoral Block and Intravenous Parecoxib For Postoperative Analgesia After Total Knee Arthroplasty
|
|
Scientific title:
|
COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY. |
|
Date of first enrolment:
|
January 2009 |
|
Target sample size:
|
90 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT02185924 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|
|
Phase:
|
Phase 2/Phase 3
|
|
|
Countries of recruitment
|
|
Greece
| | | | | | | |
|
Contacts
|
|
Name:
|
DESPOINA SARRIDOU, SENIOR REGISTRAR |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
SENIOR CLINICAL FELLOW THE ROYAL BROMPTON AND HAREFIELD TRUST, SENIOR REGISTRAR IN ANAESTHESIA ASKLEPEION VOULAS |
| | |
|
Key inclusion & exclusion criteria
|
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)
Age minimum:
40 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB
|
|
Intervention(s)
|
|
Drug: Parecoxib
|
|
Drug: N/S 0.9%
|
|
Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%
|
|
Primary Outcome(s)
|
|
HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS
[Time Frame: During perioperative period]
|
|
VAS PAIN SCORES BETWEEN TWO GROUPS
[Time Frame: 36/h POSTOPERATIVELY]
|
|
MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
[Time Frame: 36/h POSTOPERATIVELY]
|
|
Secondary Outcome(s)
|
|
ANXIETY LEVELS
[Time Frame: 36 HOURS POSTOPERATIVELY]
|
|
Secondary ID(s)
|
|
S-138/15-06-10
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|