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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125903
• Other study ID #: AZ 06/13
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: January 23, 2015
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2015
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission of the Philipps-University Department of Medicine
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adductor Canal Block
• Femoral Nerve Block
• Total Knee Arthroplasty
• Total Knee Replacement

Intervention

Drug:
• Ropivacaine
Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)

Locations

Country	Name	City	State
Germany	University of Marburg Department of Anaesthesia And Intensive Care Medicine	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain Scores	Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain	6, 24, 48, 72 hours postoperative	No
Secondary	Quadriceps strength	Numeric Scale (0-5)	6, 24, 28, 72 hours postoperative	No
Secondary	Ropivacaine consumption (each catheter)	Measurement of the total amount	24, 48, 72 hours postoperative	No
Secondary	CAS (Cumulated Ambulation Score)	Cumulated Ambulation Score is calculated with routine data. Measurement for ambulation ability	24,48,72 hours postoperative	No
Secondary	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	No
Secondary	Analgesic regimen	Documentation of analgesic prescriptions and rescue medications during postoperative course	preop and 0, 6 , 24, 48, 48 hours postoperative	No