NCT02185924

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
Last Updated

July 10, 2014

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

July 2, 2014

Last Update Submit

July 7, 2014

Conditions

POSTOPERATIVE ANALGESIA FOR TKA PARECOXIB/CFB

Keywords

PARECOXIBCONTINUOUS FEMORAL BLOCK

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • ANXIETY LEVELS

    36 HOURS POSTOPERATIVELY

Other Outcomes (2)

  • RANGE OF MOTION, TRANSFUSION REQUIREMENTS, VAS SCORES POSTOPERATIVELY

    AFTER 36 HOURS POSTOPERATIVELY

  • MODIFIED BROMAGE SCALE

    36/h POSTOPEPATIVELY

Study Arms (2)

CONTINUOUS FEMORAL BLOCK AND PARECOXIB

EXPERIMENTAL

Continuous infusion of0,2% of ropivacaine at 10 ml/h and 2 mls (40 mg) of iv parecoxib

Drug: ParecoxibDrug: 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%

Drug: CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%Drug: N/S 0.9%

Interventions

ParecoxibDRUG
Also known as: DYNASTAT
CONTINUOUS FEMORAL BLOCK AND PARECOXIB
CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%DRUG
Also known as: NAROPEINE
CONTINUOUS FEMORAL BLOCK AND PARECOXIBCONTINUOUS FEMORAL BLOCK AND PLACEBO
N/S 0.9%DRUG
Also known as: PLACEBO
CONTINUOUS FEMORAL BLOCK AND PLACEBO

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PATIENTS ASA I-II UNDERGOING TOTAL KNEE ATRTHROPLASTY

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anaesthesia Asklepeion Voulas General Hospital

Voula Athens, 16673, Greece

Location

Related Publications (1)

  • 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.

    PMID: 26861666DERIVED

MeSH Terms

Interventions

parecoxibRopivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • DESPOINA SARRIDOU, SENIOR REGISTRAR

    SENIOR CLINICAL FELLOW THE ROYAL BROMPTON AND HAREFIELD TRUST, SENIOR REGISTRAR IN ANAESTHESIA ASKLEPEION VOULAS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ANAESTHESIOLOGIST

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 10, 2014

Study Start

January 1, 2009

Primary Completion

September 1, 2011

Study Completion

February 1, 2014

Last Updated

July 10, 2014

Record last verified: 2014-07

Locations

GR(1)