NCT04344990

Brief Summary

The study compares three different analgesic techniques in order to determine which one serves as the optimal method for postoperative pain management after Total Knee Arthroplasty in patients suffering from Osteoarthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable postoperative-pain

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

June 29, 2015

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

4.3 years

First QC Date

April 19, 2017

Last Update Submit

April 9, 2020

Conditions

Postoperative PainKnee Arthroplasty

Keywords

epidural analgesiaintra-articular infusion analgesia;femoral nerve blocktotal knee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia

    Pain scores, during rest and movement (active and passive) according to NRS (Numeric Rating Scale) right after the end of the surgery and 2, 4, 6, 12, 24, 36, 48, 60 and 72 hours later (postoperatively)

    Up to 3 days

Secondary Outcomes (2)

  • Mobilization

    Up to 3 days

  • LOS

    Up to 3 months

Study Arms (3)

Group E- Epidural analgesia

ACTIVE COMPARATOR

Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure. The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The epidural catheter is placed preoperatively.

Procedure: Epidural analgesia - Group E

Group F- Femoral blockade

ACTIVE COMPARATOR

Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The femoral catheter is placed preoperatively.

Procedure: Femoral blockade - Group F

Group I- Intraarticular infusion

ACTIVE COMPARATOR

Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg for postoperative pain management right after the end of the procedure.The PCA pump is programmed with continuous infusion (Ropivacaine 0.2% + clonidine 150μg) 2ml/h and bolus dosage 0,5ml per 15min (max dosage 2ml/h). The intraarticular catheter is placed before the closure of the incision.

Procedure: Intraarticular infusion - Group I

Interventions

Epidural analgesia - Group EPROCEDURE

Postoperative analgesia with continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)

Group E- Epidural analgesia
Femoral blockade - Group FPROCEDURE

Postoperative analgesia with continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) .

Group F- Femoral blockade
Intraarticular infusion - Group IPROCEDURE

Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)

Group I- Intraarticular infusion

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for unilateral total knee arthroplasty (TKA) to treat knee osteoarthritis (OA)
  • Fully conversant in the Greek language
  • Written informed consent to participate in the trial

You may not qualify if:

  • Age less than 50 years and greater than 85 years.
  • ASA score \>III
  • Pregnancy
  • Subarachnoid anesthesia failure
  • Hypersensitivity/ allergy to certain agent used
  • Participation in other research/ study
  • Severe mental disease (schizophrenia, major depression, severe bipolar disorder, substance abuse)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Fotini Fligou, MD, PhD

    University of Patras, Department of Anesthesiology and Critical Care Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist MD

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 14, 2020

Study Start

June 29, 2015

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)