Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome

Total Knee Arthroplasty & Outcome: A Prospective Randomized Comparison Between Adductor Canal Block and Femoral Nerve Block

Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.

Study Overview

• Status: Withdrawn
• Conditions: Total Knee Arthroplasty
• Intervention / Treatment: Drug: Morphine; Drug: Levobupivacaine 0,5%; Drug: Ketorolac 30mg; Procedure: Adductor canal; Procedure: Spinal Anesthesia; Procedure: Local anesthetic infusion; Procedure: Intravenous analgesia; Drug: Ropivacaine 0,75%; Drug: Levobupivacaine 0,125%; Device: stimulong sono, Pajunk, Germany; Procedure: Femoral

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Istituto Ortopedico Gaetano Pini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients undergoing total knee arthroplasty

Exclusion Criteria:

• diabetes
• neurological disorders
• coagulation disorders
• rheumatoid arthritis
• chronic opioids therapy
• allergy to local anesthetic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Adductor canal; All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.	Drug: Morphine; Drug: Levobupivacaine 0,5%; Drug: Ketorolac 30mg; Procedure: Adductor canal; Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.; Procedure: Spinal Anesthesia; Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.; Procedure: Local anesthetic infusion; Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.; Procedure: Intravenous analgesia; Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.; Drug: Ropivacaine 0,75%; Drug: Levobupivacaine 0,125%; Device: stimulong sono, Pajunk, Germany
ACTIVE_COMPARATOR: Femoral; All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.	Drug: Morphine; Drug: Levobupivacaine 0,5%; Drug: Ketorolac 30mg; Procedure: Spinal Anesthesia; Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.; Procedure: Local anesthetic infusion; Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.; Procedure: Intravenous analgesia; Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.; Drug: Ropivacaine 0,75%; Drug: Levobupivacaine 0,125%; Device: stimulong sono, Pajunk, Germany; Procedure: Femoral; Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.
PLACEBO_COMPARATOR: Controls; No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.	Drug: Morphine; Drug: Levobupivacaine 0,5%; Drug: Ketorolac 30mg; Procedure: Spinal Anesthesia; Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.; Procedure: Intravenous analgesia; Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Up and Go test	Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair	5th postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS score	Evaluation of VAS static and VAS dynamic during hospital stay	up to POD5
Morphine request	Opioids consumption will be recorded throughout postoperative period	up to POD5
Range of motion	Physiotherapist measures the maximum active/passive range of motion	5th postoperative day
Falling risk	Evaluation of falling risk with Berg Balance Scale	5th postoperative day
Quadriceps strength	evaluate muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°.	5th postoperative day

Collaborators and Investigators

• Sponsor: ASST Gaetano Pini-CTO

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ANTICIPATED): September 1, 2015
• Study Completion (ANTICIPATED): March 1, 2016

Study Registration Dates

• First Submitted: February 28, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (ESTIMATE): March 10, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Anesthetics; Ketorolac; Anesthetics, Local; Ropivacaine; Morphine; Levobupivacaine
• Other Study ID Numbers: IOGPGC05-14