Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy

Randomized Controlled Study: Comparison of Continuous Femoral Nerve Block and Adductor Canal Block After Total Knee Replacement Therapy Relating to Early Mobilization and Analgesia

The blockade of the femoral nerve (FNB) is the most common postoperative pain therapy after total knee replacement. Because of motor-driven weakness of the quadriceps muscle induced by femoral nerve block mobilization of Patients is difficult even dangerous (falls) and hospital stays are extended.

An alternative method could be an adductor canal block (ACB). Anatomical studies of the adductor canal demonstrated that the adductor canal contains the saphenous nerve, a pure sensory nerve for medial and anterior aspects of the knee and the tibia without any motor function.

This prospective, double-blinded, randomized study investigates the effect of FNB and ACB on quadriceps motor weakness and analgesia determined by Numeric Rating Scale (NRS).

We expect the ACB to be superior in muscle strength but equal in pain score. Both groups receive an additional anterior sciatic nerve block for complete sensory block of the operated knee

Study Overview

• Status: Completed
• Conditions: Total Knee Arthroplasty; Total Knee Replacement; Adductor Canal Block; Femoral Nerve Block
• Intervention / Treatment: Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Marburg, Germany, 35037
    • University of Marburg Department of Anaesthesia And Intensive Care Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• patients with knee replacement therapy and general anaesthesia
• informed consent
• preoperative "timed up and go" test performable

Exclusion Criteria:

• emergency patients
• BMI > 40 kg/m2
• American Society of Anaesthesiologists physical status (ASA) 4-5
• severe chronic obstructive pulmonary disease (COPD)
• rheumatic arthritis, diabetic Polyneuropathy, M. Parkinson
• nerve injury of lumbosacral plexus
• coagulopathy with bleeding tendency
• not capable of speaking or understanding german or english

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous Adductor Canal Block (CACB); Continuous Adductor Canal block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine	Drug: Ropivacaine; Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
Active Comparator: Continuous Femoral Nerve Block (CFNB); Continuous Femoral Nerve Block performed with: loading dose 0,375% Ropivacaine 15ml (56,25mg) start infusion 0,2% Ropivacaine 6ml/h Procedure: Femoral Nerve Block. Adductor Canal Block Drug: Ropivacaine	Drug: Ropivacaine; Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed-Up and Go-test for mobility evaluation	The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.	third postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain	6, 24, 48, 72 hours postoperative
Quadriceps strength	Numeric Scale (0-5)	6, 24, 28, 72 hours postoperative
Ropivacaine consumption (each catheter)	Measurement of the total amount	24, 48, 72 hours postoperative
CAS (Cumulated Ambulation Score)	Cumulated Ambulation Score is calculated with routine data. Measurement for ambulation ability	24,48,72 hours postoperative
Mobility Score (MoSc)	Is calculated with routine data. Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)	24,48,72 hours postoperative
Analgesic regimen	Documentation of analgesic prescriptions and rescue medications during postoperative course	preop and 0, 6 , 24, 48, 48 hours postoperative

Collaborators and Investigators

• Sponsor: Philipps University Marburg Medical Center
• Investigators: Study Director: Karolin Piechowiak, Dr, Dept. of Anesthesia And Intensiv Care Medicine University of Marburg; Study Director: Thorsten Steinfeldt, Prof Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg; Study Director: Thomas Wiesmann, Dr, Dept. of Anesthesia And Intensive Care Medicine University of Marburg

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 5, 2014
• First Submitted That Met QC Criteria: April 28, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): January 26, 2015
• Last Update Submitted That Met QC Criteria: January 23, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: AZ 06/13