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

Phase 3

Completed

• Conditions: Pain, Postoperative; Gonarthrosis; Anesthesia, Local
• Interventions: Drug: Ultrasound guided regional anesthesia; Drug: Local infiltration analgesia

• Registration Number: NCT04697537
• Lead Sponsor: Medical University of Graz

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.

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-06
• Study Start: 2021-02-01
• Status Verified: 2021-04
• Primary Completion: 2021-04-09
• Study Completion: 2021-04-09
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound guided regional anesthesia	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).
Local infiltration analgesia	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).

Primary Outcome Measures

Name	Time	Method
Need of opioid consumption in oral morphine equivalent	48 hours postoperatively	consumed opioids in mg of oral morphine equivalent

Secondary Outcome Measures

Name	Time	Method
Pain assesment	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)
Pain medication necessary	5 days postoperatively or until discharge	Need of opioid consumption in mg of oral morphine equivalent up to the 5th postoperative day
Functionality of the prothesis - OKS (Oxford Knee Score)	5 days postoperatively or until discharge	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)	5 days postoperatively or until discharge	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)	5 days postoperatively or until discharge	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)	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)
Complications	5 days postoperatively or until discharge	Incidence of complications in total (e.g. delirium, allergic reactions, cardiopulmonary decompensation)
procedure specific time	during surgery	time of the operation

Trial Locations

Locations (1)

Medical University Hospital LKH Graz; 🇦🇹 Graz, Austria