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

Primary Purpose

Pain, Postoperative, Anesthesia, Local, Gonarthrosis

Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Ultrasound guided regional anesthesia
Local infiltration analgesia
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University Hospital LKH Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound guided regional anesthesia

Local infiltration analgesia

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Need of opioid consumption in oral morphine equivalent
consumed opioids in mg of oral morphine equivalent

Secondary Outcome Measures

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)
Pain medication necessary
Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day
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)
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)
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)
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)
Complications
Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation)
procedure specific time
time of the operation

Full Information

First Posted
January 4, 2021
Last Updated
April 13, 2021
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT04697537
Brief Title
Ultrasound-guided Regional Anesthesia vs Local Infiltration Anesthesia With Dexmedetomidine and Ropivacaine
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
April 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anesthesia, Local, Gonarthrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound guided regional anesthesia
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Local infiltration analgesia
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ultrasound guided regional anesthesia
Other Intervention Name(s)
dexmedetomidine, Ropivacaine
Intervention Description
Applied perineurally preoperatively ultrasound guided regional anesthesia
Intervention Type
Drug
Intervention Name(s)
Local infiltration analgesia
Other Intervention Name(s)
dexmedetomidine, Ropivacaine
Intervention Description
Applied in the wound intraoperatively from the orthopedics
Primary Outcome Measure Information:
Title
Need of opioid consumption in oral morphine equivalent
Description
consumed opioids in mg of oral morphine equivalent
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain assesment
Description
Pain experienced by patients according to self-assesment according to NRS (Numeric rating scale) (minimum 0, maximum 10) (higher score means worse outcome)
Time Frame
5 days postoperatively or until discharge
Title
Pain medication necessary
Description
Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day
Time Frame
5 days postoperatively or until discharge
Title
Functionality of the prothesis - OKS (Oxford Knee Score)
Description
According to physical examination by the Oxford Knee Score (minimum 0, maximum 48) (higher score means better outcome)
Time Frame
5 days postoperatively or until discharge
Title
Functionality of the prothesis- KOOS (Knee Injury and Osteoarthritis Outcome Score)
Description
According to physical examination by the orthopedics score KOOS (minimum 0, maximum 100) (higher score means better outcome)
Time Frame
5 days postoperatively or until discharge
Title
Functionality of the prothesis - WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Description
According to physical examination by the orthopedics score WOMAC (minimum 0, maximum 96) (higher score means worse outcome)
Time Frame
5 days postoperatively or until discharge
Title
Functionality of the prothesis- G-FJS (German Forgotten Joint Score)
Description
According to physical examination by the orthopedics score G-FJS (minimum 0, maximum 100) (higher score means better outcome)
Time Frame
5 days postoperatively or until discharge
Title
Complications
Description
Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation)
Time Frame
5 days postoperatively or until discharge
Title
procedure specific time
Description
time of the operation
Time Frame
during surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregor A Schittek, MD
Organizational Affiliation
Med Uni Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Hospital LKH Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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