Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty

Continuous Adductor Canal Block in Comparison to Continuous Femoral Nerve Block in Patients After Total Knee Arthroplasty: Randomized Control Trail

Comparison of continuous adductor canal block to continuous femoral nerve block in patients after total knee arthroplasty.

All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine with a catheter implemented to the adductor canal or next to the femoral nerve.

The observed goals: pain intensity, the beginning and quality of rehabilitation.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Pain, Acute; Mobility Limitation; Knee Arthropathy
• Intervention / Treatment: Procedure: continuous anesthesia of adductor canal; Procedure: Spinal anesthesia; Procedure: continuous anesthesia of femoral nerve

Detailed Description

Written consent will be obtained a day before the surgery. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

Before the beginning of operation, under ultrasound control, a catheter will be implemented to one of the chosen position: the adductor canal (the middle or lower third of thigh) or near the femoral nerve (below the inguinal ligament). The local anesthetic solution of 0.2 % ropivacaine will be started with an elastomeric pump (5 mL per hour, up to 72 hours) as soon as a catheter in the right position.

The pain will be measured with VAS (visual-analogue scale) 8, 24 and 48 hours after the end of operation, and at the discharge. At the same time, i.e.: 8, 24 and 48 hours from the end of surgery, the range of flexion and extension in the operated knee will be assessed. Moreover, the possibility of patient's sitting, standing up and walking will be noted.

All parameters will be reassessed before patients' discharge from the hospital. Each patient will receive paracetamol (1.0) and metamizol (1.0) intravenously (i.v.) q6h. 5 mg of morphine may be given as required, up to 2 dosages per day as a rescue medication.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lublin, Poland, 20-081
    • Michał Borys

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• knee arthroplasty
• obtained consent
• subarachnoid anaesthesia

Exclusion Criteria:

• coagulopathy
• allergy to to local anesthetics
• depression, antidepressant drugs treatment
• epilepsy
• usage of painkiller before surgery
• addiction to alcohol or recreational drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: continuous anesthesia of adductor canal	Procedure: continuous anesthesia of adductor canal; After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented to the adductor canal and infusion of 5 mL/h of 0.2 % ropivacaine will be started.; Procedure: Spinal anesthesia; Before the beginning of surgery all patients will be anesthetised with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 2.0 - 2.5 mL solution. Pencil point spinal needle will be used.; Other Names: Subarachnoid anesthesia
Experimental: continuous anesthesia of femoral nerve	Procedure: Spinal anesthesia; Before the beginning of surgery all patients will be anesthetised with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 2.0 - 2.5 mL solution. Pencil point spinal needle will be used.; Other Names: Subarachnoid anesthesia; Procedure: continuous anesthesia of femoral nerve; After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented next to the femoral nerve (below inguinal ligament) and infusion of 5 mL/h of 0.2 % ropivacaine will be started.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphine consumption	Total consumption of intravenous morphine by patients with the use of patient-controlled analgesia pump	24 hours from the end of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee flexion	range of flexion in operated knee	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Walking	Possibility of walking by patients at scheduled time points	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
The change of acute postoperative pain	Measured with VAS (visual-analogue scale)	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Sitting	Possibility of walking by patients at scheduled time points	8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)

Collaborators and Investigators

• Sponsor: Medical University of Lublin
• Collaborators: Konskie Specjalist Hospital
• Investigators: Principal Investigator: Michał Borys, M.D., PhD, Medical University of Lublin

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): July 26, 2018

Study Registration Dates

• First Submitted: May 3, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation; knee replacement; regional anesthesia; pain treatment
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Mobility Limitation; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: KE-0254/188/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No