The effect of saphenous nerve and obturator nerve block combined with intravenous given glucocorticoid compared with infiltration of local anesthetic in the tissue around the knee joint combined with intravenous given glucocorticoid, on opioid consumption and pain after total knee arthroplasty.

Phase 1

Conditions: The medical condition to be examined in this study is the first postoperative period after total knee replacement with a view to pain management.
MedDRA version: 17.1Level: LLTClassification code 10038286Term: Regional nerve blockSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2014-003343-35-DK

Lead Sponsor: Thomas Fichtner Bendtsen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Age> 50 years
• Patients set to cemented Total knee arthroplasty in spinal block
• ASA 1-3

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 64

Exclusion Criteria

• Patients who can not cooperate with the investigation
• Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
• Patients who do not understand or speak Danish
• Patients receiving immunosuppressive therapy
•Patients receiving glucocorticoid daily
• Patients with a treatment-dependent diabetes mellitus
• Patients with known neuropathy in the lower limbs
• Allergy to those used in the study drugs
• Alcohol and / or drug abuse - the investigator's opinion
• Patients who can not tolerate NSAIDs
• Fixed several times daily consumption of strong opioids (morphine, ketogan,
Oxynorm, methadone, fentanyl)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim is to investigate the effect of combined saphenous nerve and obturator nerve block with a mixture of local analgesics; ropivacaine and adrenaline, compared with combined local infiltration analgesia in the tissue around the knee joint both methods combined with systemic high dose glucocorticoid on opioid consumption after total knee arthroplasty.;Secondary Objective: Secondarily it is to investigate the effect of combined saphenous nerve and obturator nerve blockade compared with local infiltration analgesia in the tissue around the knee joint both methods combined with a systemic high dose glucocorticoid on pain and block duration after total knee arthroplasty.;Primary end point(s): • Consumption of opioid from 0 to 20 hours postoperatively, via patient-controlled analgesia-(PCA) pump. The patient is instructed to self-administer a dose when NRS (numeric rating scale) > 3 at rest.;Timepoint(s) of evaluation of this end point: Time 20 hours postoperatively

Secondary Outcome Measures