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

NCT ID: NCT04697537

Last Updated: 2021-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2021-04-09

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.

Conditions

Pain, Postoperative; Anesthesia, Local; Gonarthrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Ultrasound guided regional anesthesia

Intervention Type: DRUG

Applied perineurally preoperatively ultrasound guided regional anesthesia

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).

Group Type: ACTIVE_COMPARATOR

Local infiltration analgesia

Intervention Type: DRUG

Applied in the wound intraoperatively from the orthopedics

Interventions

Ultrasound guided regional anesthesia

Applied perineurally preoperatively ultrasound guided regional anesthesia

Intervention Type: DRUG

Local infiltration analgesia

Applied in the wound intraoperatively from the orthopedics

Intervention Type: DRUG

Other Intervention Names

dexmedetomidine; Ropivacaine; dexmedetomidine; Ropivacaine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregor A Schittek, MD

Role: PRINCIPAL_INVESTIGATOR

Med Uni Graz

Locations

Medical University Hospital LKH Graz

Graz, , Austria

Countries

Austria

Other Identifiers

GAS1.0

Identifier Type: -

Identifier Source: org_study_id