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Completed

NCT Number: NCT04697537

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

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.

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Key information

Conditions

Pain, Postoperative Anesthesia, Local Arthritis Gonarthrosis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University Hospital LKH Graz

Graz, 8036, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound guided regional anesthesia

Drug

Applied perineurally preoperatively ultrasound guided regional anesthesia

Other names: dexmedetomidine, Ropivacaine

Local infiltration analgesia

Drug

Applied in the wound intraoperatively from the orthopedics

Other names: dexmedetomidine, Ropivacaine

Primary outcomes

  1. Need of opioid consumption in oral morphine equivalent

    Time frame: 48 hours postoperatively

    consumed opioids in mg of oral morphine equivalent

Secondary outcomes

  1. Pain assesment

    Time frame: 5 days postoperatively or until discharge

    Pain experienced by patients according to self-assesment according to NRS (Numeric rating scale) (minimum 0, maximum 10) (higher score means worse outcome)

  2. Pain medication necessary

    Time frame: 5 days postoperatively or until discharge

    Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day

  3. Functionality of the prothesis - OKS (Oxford Knee Score)

    Time frame: 5 days postoperatively or until discharge

    According to physical examination by the Oxford Knee Score (minimum 0, maximum 48) (higher score means better outcome)

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

    Time frame: 5 days postoperatively or until discharge

    According to physical examination by the orthopedics score KOOS (minimum 0, maximum 100) (higher score means better outcome)

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

    Time frame: 5 days postoperatively or until discharge

    According to physical examination by the orthopedics score WOMAC (minimum 0, maximum 96) (higher score means worse outcome)

  6. Functionality of the prothesis- G-FJS (German Forgotten Joint Score)

    Time frame: 5 days postoperatively or until discharge

    According to physical examination by the orthopedics score G-FJS (minimum 0, maximum 100) (higher score means better outcome)

  7. Complications

    Time frame: 5 days postoperatively or until discharge

    Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation)

  8. procedure specific time

    Time frame: during surgery

    time of the operation

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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