Effect of Mode of Femoral Nerve Analgesia on Quadriceps Muscle Strength

Effect of Continuous Femoral Analgesia on Quadriceps Muscle Strength-0.2% Ropivacaine Continuous Infusion Versus Patient Controlled Femoral Analgesia

Quadriceps muscle strength is an important determinant of quality of recovery in elderly patients after total knee arthroplasty. We try to compare the quadriceps muscle strength change between 0.2 % ropivacaine continuous fixed femoral infusion and patient controlled femoral analgesia group.

Study Overview

• Status: Unknown
• Conditions: Muscle Weakness
• Intervention / Treatment: Drug: ropivacaine

Detailed Description

Continuous femoral nerve analgesia technique is relatively safe, can be easily trained, and reduces significantly intravenous opioid consumption. These favorable features make it standard treatment option for postoperative knee pain. However, direct perineural local anesthetic effect is not only confined into pain fiber, but, the other sensory and motor nerve fibers. Therefore, unwanted motor weakness is accompanied. Quadriceps muscle strength, which is important determinant of physical function after knee arthroplasty, can be influenced in continuous femoral nerve block. Various local anesthetic infusion techniques have been suggested to minimize the change of quadriceps muscle strength. Decreasing local anesthetic concentrations affect not only degree of muscle weakness, but also reduces the quality of pain control. Different anatomic location of catheter tip, considering motor fiber in posterior part of femoral nerve, could not reduce motor weakness. In a study with continuous popliteal-sciatic nerve blocks after hallux valgus repair, repeated bolus administration seems to be more effective method for pain control without concurrent motor impairment. However, another study with continuous femoral nerve block in healthy volunteers, hourly repeated bolus dose of 5 ml of 0.1% ropivacaine failed to spare motor block. Previously, our institution standard technique is fixed continuous infusion of 0.2% ropivacaine and concomitant intravenous patient controlled fentanyl. Because physical therapy of our institution, usually starts with the 2nd day of operation, so, we assume that continuous fixed infusion may result in more drug accumulation near nerve fiber. So, patient controlled mode of femoral analgesia could be better choice for initiation of physical therapy. At the same time, comparison between patient controlled analgesia and continuous infusion is not fully elucidated until recently. Therefore, in this study, we try to compare quadriceps muscle strength change between continuous infusion and patient controlled femoral analgesia in patients undergoing total knee replacement arthroplasty. Secondary outcomes include sensory effect in femoral nerve distribution, pain scores, iv fentanyl consumption, and other adverse effects.

• Study Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyungido
    • Sungnam, Gyungido, Korea, Republic of, 463-707
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Hae Wone Chang, MD; Phone Number: 82-031-787-6261; Email: chelenh@gmail.com
      • Principal Investigator: Hae Wone Chang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 21, or < 80 years old- men and women
• primary, unilateral total knee replacement surgery
• spinal anesthesia

Exclusion Criteria:

• general anesthesia
• secondary knee replacement surgery
• patient refusal for continuous femoral nerve analgesia technique
• abnormal coagulation profile, e.g. Prothrombin time international normalized ratio > 1.5, activated partial thrombin time > 50 sec
• within 5 days after termination oral antiplatelet agent
• Body mass index>45
• impaired renal function
• infection near femoral area
• previous injury near femoral area
• neurologic dysfunction in lower limb
• previous adverse drug reaction for local anesthetics
• American society of anesthesiologists (ASA) class III, iV or V

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: ropivacaine continuous mode; 0.2% ropivacaine 8 ml/hr through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl	Drug: ropivacaine; Patients receive 15 ml of 0.25% ropivacaine pre-operatively through femoral block catheter, followed by 0.2% ropivacaine continuous mode or patient controlled mode for 2 days after surgery; Other Names: femoral nerve block
Active Comparator: ropivacaine patient controlled mode; 0.2% ropivacaine patient controlled mode, basal rate 4 ml/hr, bolus 4 ml, lockout 60 minutes through femoral nerve block catheter for 2 days and they have patient controlled intravenous fentanyl	Drug: ropivacaine; Patients receive 15 ml of 0.25% ropivacaine pre-operatively through femoral block catheter, followed by 0.2% ropivacaine continuous mode or patient controlled mode for 2 days after surgery; Other Names: femoral nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of quadriceps muscle strength	maximum voluntary isometric contraction of quadriceps femoris with hand held manometry	Baseline, Postoperative 2nd day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sensory changes in femoral nerve distribution	tolerance to transcutaneous electrical stimulation	postoperative 2 day
pain scores	verbal numeric pain scale (0-100) resting/dynamic	postoperative 1 day
pain scores	verbal numeric pain scale (0-100) resting/dynamic	postoperative 2 day
intravenous fentanyl consumption	cumulative fentanyl consumption on postoperative 2 day	postoperative 2 day

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Hae Wone Chang, M.D., Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): February 1, 2015
• Study Completion (Anticipated): July 1, 2015

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: December 5, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: knee arthroplasty; continuous femoral nerve block; quadriceps muscle strength
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Weakness; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: B-1308/214-010