NCT04697537

Brief Summary

Evaluation of the Impact of dexmedetomidine as an adjunct for local infiltrations analgesia and ultrasound-based regional anaesthesia as pain medication in regard to patients' opioid need the first 48 hours after the total knee replacement operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_3

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

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
26 days until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2021

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

January 4, 2021

Last Update Submit

April 13, 2021

Conditions

Pain, PostoperativeAnesthesia, LocalGonarthrosis

Outcome Measures

Primary Outcomes (1)

  • Need of opioid consumption in oral morphine equivalent

    consumed opioids in mg of oral morphine equivalent

    48 hours postoperatively

Secondary Outcomes (8)

  • Pain assesment

    5 days postoperatively or until discharge

  • Pain medication necessary

    5 days postoperatively or until discharge

  • Functionality of the prothesis - OKS (Oxford Knee Score)

    5 days postoperatively or until discharge

  • Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score)

    5 days postoperatively or until discharge

  • Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)

    5 days postoperatively or until discharge

  • +3 more secondary outcomes

Study Arms (2)

Ultrasound guided regional anesthesia

ACTIVE COMPARATOR

Patient will be given a peripheral nerve block from their treating anesthesiologist before the operation (in the OR) with an conventional ultrasound guided femoral and sciatic block of each 15 ml ropivacaine 0,5% and 0,5 ml dexmedetomidine (100µg/ml).

Drug: Ultrasound guided regional anesthesia

Local infiltration analgesia

ACTIVE COMPARATOR

Patient will be given a local infiltration analgesia from their treating surgeon during the operation (in the OR) with 60 ml ropivacaine 0,5% and 1 ml dexmedetomidine (100µg/ml).

Drug: Local infiltration analgesia

Interventions

Ultrasound guided regional anesthesiaDRUG

Applied perineurally preoperatively ultrasound guided regional anesthesia

Also known as: dexmedetomidine, Ropivacaine
Ultrasound guided regional anesthesia
Local infiltration analgesiaDRUG

Applied in the wound intraoperatively from the orthopedics

Also known as: dexmedetomidine, Ropivacaine
Local infiltration analgesia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult
  • non pregnant
  • patients with gonarthrosis who have given written consent for participation

You may not qualify if:

  • Age below 18 years
  • pregnancy
  • breast-feeding patients
  • allergies against study medication
  • missing or denied written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Hospital LKH Graz

Graz, 8036, Austria

Location

MeSH Terms

Conditions

Pain, PostoperativeOsteoarthritis, Knee

Interventions

DexmedetomidineRopivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsOsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Gregor A Schittek, MD

    Med Uni Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

February 1, 2021

Primary Completion

April 9, 2021

Study Completion

April 9, 2021

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

Data will be made available upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be made available upon reasonable request
Access Criteria
Data will be made available upon reasonable request

Locations

AU(1)