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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04697537
• Other study ID #: GAS1.0
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: April 9, 2021

Study information

• Verified date: April 2021
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 9, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Local
• Gonarthrosis
• Osteoarthritis, Knee
• Pain, Postoperative

Intervention

Drug:
• Ultrasound guided regional anesthesia
Applied perineurally preoperatively ultrasound guided regional anesthesia
• Local infiltration analgesia
Applied in the wound intraoperatively from the orthopedics

Locations

Country	Name	City	State
Austria	Medical University Hospital LKH Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need of opioid consumption in oral morphine equivalent	consumed opioids in mg of oral morphine equivalent	48 hours postoperatively
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Complications	Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation)	5 days postoperatively or until discharge
Secondary	procedure specific time	time of the operation	during surgery