POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFBPhase 2/3NCT02185924
Combination of Continuous Femoral Block and Intravenous Parecoxib For Postoperative Analgesia After Total Knee Arthroplasty
A Phase 2/3 study testing Parecoxib, CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% and N/S 0.9% in people with POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB
- What is being tested?
- Parecoxib, CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% and N/S 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2009to Feb 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENTS ASA I-II UNDERGOING TOTAL KNEE ATRTHROPLASTY
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Anaesthesia Asklepeion Voulas General Hospital
Voula Athens, 16673
About this study
Official title: 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
- Being tested
- Parecoxib, CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%, N/S 0.9%
- Keywords
- PARECOXIB, CONTINUOUS FEMORAL BLOCK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParecoxibDrug
Also called DYNASTAT
CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%Drug
Also called NAROPEINE
N/S 0.9%Drug
Also called PLACEBO
| Study group | Role | What they receive |
|---|---|---|
| CONTINUOUS FEMORAL BLOCK AND PARECOXIB | Experimental | Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib Receives: Drug: Parecoxib; Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% |
| CONTINUOUS FEMORAL BLOCK AND PLACEBO | Placebo comparator | Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9% Receives: Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%; Drug: N/S 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
Measured: 36/h POSTOPERATIVELY
VAS PAIN SCORES BETWEEN TWO GROUPS
Measured: 36/h POSTOPERATIVELY
HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS
Measured: During perioperative period
Secondary outcomes (1)
ANXIETY LEVELS
ANXIETY SCORES WERE QUANTIFIED USING THE SPIELBERG INVENTORY
Measured: 36 HOURS POSTOPERATIVELY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJan 2009
- Primary completionSep 2011
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Despoina Sarridou, Asklepieion Voulas General Hospital
- Investigators
- DESPOINA SARRIDOU, SENIOR REGISTRAR, Principal investigator, SENIOR CLINICAL FELLOW THE ROYAL BROMPTON AND HAREFIELD TRUST, SENIOR REGISTRAR IN ANAESTHESIA ASKLEPEION VOULAS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185924
- Sponsor's protocol ID
- S-138/15-06-10
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 26861666
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMBINATION OF CONTINUOUS FEMORAL BLOCK AND INTRAVENOUS PARECOXIB FOR POSTOPERATIVE ANALGESIA AFTER TOTAL KNEE ARTHROPLASTY. A DOUBLE BLIND PROSPECTIVE STUDY.
- ClinicalTrials.gov ID
- NCT02185924
- Acronym / sponsor ID
- S-138/15-06-10
- Keywords
- PARECOXIB, CONTINUOUS FEMORAL BLOCK
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Study start
- Jan 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTINUOUS FEMORAL BLOCK AND PARECOXIB | Experimental | Drug: Parecoxib, Drug: 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 PLACEBO | Placebo comparator | Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%, Drug: N/S 0.9%Continuous infusion of 0.2% ropivacaine at 10 ml/h and 2 mls of iv N/S0.9% |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PATIENTS ASA I-II UNDERGOING TOTAL KNEE ATRTHROPLASTY
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParecoxibAlso: DYNASTAT | Drug | CONTINUOUS FEMORAL BLOCK AND PARECOXIB |
| CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%Also: NAROPEINE | Drug | CONTINUOUS FEMORAL BLOCK AND PARECOXIB, CONTINUOUS FEMORAL BLOCK AND PLACEBO |
| N/S 0.9%Also: PLACEBO | Drug | CONTINUOUS FEMORAL BLOCK AND PLACEBO |
Primary outcome
MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS
Time frame: 36/h POSTOPERATIVELY
VAS PAIN SCORES BETWEEN TWO GROUPS
Time frame: 36/h POSTOPERATIVELY
HAEMODYNAMIC PARAMETERS BETWEEN TWO GROUPS
Time frame: During perioperative period
1 secondary outcome
ANXIETY LEVELS
Time frame: 36 HOURS POSTOPERATIVELY
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Derived from this study: PubMed 26861666Sarridou 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DESPOINA SARRIDOU, SENIOR REGISTRAR principal investigator
SENIOR CLINICAL FELLOW THE ROYAL BROMPTON AND HAREFIELD TRUST, SENIOR REGISTRAR IN ANAESTHESIA ASKLEPEION VOULAS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Parecoxib, CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2% and N/S 0.9% in people with POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB, run by Asklepieion Voulas General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MORPHINE CONSUMPTION WITH PCA BETWEEN TWO GROUPS (time frame: 36/h POSTOPERATIVELY). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.