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

Medical University of Graz

Status and phase: Completed; Phase 3

Conditions: Anesthesia, Local; Pain, Postoperative; Gonarthrosis

Treatments: Drug: Local infiltration analgesia; Drug: Ultrasound guided regional anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04697537

GAS1.0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Ultrasound guided regional anesthesia

Active Comparator group

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).

Treatment:

Drug: Ultrasound guided regional anesthesia

Local infiltration analgesia

Active Comparator group

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).

Treatment:

Drug: Local infiltration analgesia