Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine

Dexmedetomidine as Adjunct Medication to Local Infiltration Anesthesia (LIA) vs Ultrasound-Guided Regional Anesthesia (USRA) in Regard to Patients' Need for Opioids, Wellbeing, Satisfaction, and Knee Functionality in Knee-endoprosthetics

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anesthesia, Local; Gonarthrosis
• Intervention / Treatment: Drug: Ultrasound guided regional anesthesia; Drug: Local infiltration analgesia

Detailed Description

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. Secondary objectives are: Pain assesment, Pain medication necessary, functionality of the prothesis, satisfaction, wellbeing, postoperative discomforts, complications (delirium, allergic reactions, cardiopulmonary decompensation), procedure specific time.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria, 8036
    • Medical University Hospital LKH Graz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound guided regional anesthesia; 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; Applied perineurally preoperatively ultrasound guided regional anesthesia; Other Names: Ropivacaine; dexmedetomidine
Active Comparator: Local infiltration analgesia; 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; Applied in the wound intraoperatively from the orthopedics; Other Names: Ropivacaine; dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need of opioid consumption in oral morphine equivalent	consumed opioids in mg of oral morphine equivalent	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain assesment	Pain experienced by patients according to self-assesment according to NRS (Numeric rating scale) (minimum 0, maximum 10) (higher score means worse outcome)	5 days postoperatively or until discharge
Pain medication necessary	Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day	5 days postoperatively or until discharge
Functionality of the prothesis - OKS (Oxford Knee Score)	According to physical examination by the Oxford Knee Score (minimum 0, maximum 48) (higher score means better outcome)	5 days postoperatively or until discharge
Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score)	According to physical examination by the orthopedics score KOOS (minimum 0, maximum 100) (higher score means better outcome)	5 days postoperatively or until discharge
Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)	According to physical examination by the orthopedics score WOMAC (minimum 0, maximum 96) (higher score means worse outcome)	5 days postoperatively or until discharge
Functionality of the prothesis- G-FJS (German Forgotten Joint Score)	According to physical examination by the orthopedics score G-FJS (minimum 0, maximum 100) (higher score means better outcome)	5 days postoperatively or until discharge
Complications	Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation)	5 days postoperatively or until discharge
procedure specific time	time of the operation	during surgery

Collaborators and Investigators

• Sponsor: Medical University of Graz
• Investigators: Principal Investigator: Gregor A Schittek, MD, Med Uni Graz

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): April 9, 2021
• Study Completion (Actual): April 9, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 13, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Knee; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Ropivacaine
• Other Study ID Numbers: GAS1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon reasonable request
• IPD Sharing Time Frame: Data will be made available upon reasonable request
• IPD Sharing Access Criteria: Data will be made available upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No