Effect of Mode of Femoral Nerve Analgesia on Quadriceps Muscle Strength

Muscle Weakness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02007850
• Other study ID #: B-1308/214-010
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2013
• Last updated: July 29, 2014
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: July 2014
• Source: Seoul National University Hospital
• Contact: Hae Wone Chang, M.D
• Phone: 82-031-787-7499
• Email: chelenh[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Paresis

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam	Gyungido

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of quadriceps muscle strength	maximum voluntary isometric contraction of quadriceps femoris with hand held manometry	Baseline, Postoperative 2nd day	No
Secondary	sensory changes in femoral nerve distribution	tolerance to transcutaneous electrical stimulation	postoperative 2 day	No
Secondary	pain scores	verbal numeric pain scale (0-100) resting/dynamic	postoperative 1 day	No
Secondary	pain scores	verbal numeric pain scale (0-100) resting/dynamic	postoperative 2 day	No
Secondary	intravenous fentanyl consumption	cumulative fentanyl consumption on postoperative 2 day	postoperative 2 day	No