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

• Sponsor: Philipps University Marburg Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02125903
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 18
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty; Total Knee Replacement; Femoral Nerve Block; Adductor Canal Block	Drug: Ropivacaine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Timed-Up and Go-test for mobility evaluation [third postoperative day]

   The patient is observed and timed while he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again.

Secondary Outcome Measures

1. Pain Scores [6, 24, 48, 72 hours postoperative]

   Numeric Rating Scale (NRS), 0-10 for Rest / Stress. in Addition total Body NRS Pain

2. Quadriceps strength [6, 24, 28, 72 hours postoperative]

   Numeric Scale (0-5)

3. Ropivacaine consumption (each catheter) [24, 48, 72 hours postoperative]

   Measurement of the total amount

4. CAS (Cumulated Ambulation Score) [24,48,72 hours postoperative]

   Cumulated Ambulation Score is calculated with routine data. Measurement for ambulation ability

5. Mobility Score (MoSc) [24,48,72 hours postoperative]

   Is calculated with routine data. Measurement for overall mobilization (none- passive mobilization, sitting, standing, walking with walking device, walkin free or with crutches)

6. Analgesic regimen [preop and 0, 6 , 24, 48, 48 hours postoperative]

   Documentation of analgesic prescriptions and rescue medications during postoperative course

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Marburg Department of Anaesthesia And Intensive Care Medicine	Marburg		Germany	35037

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karolin Piechowiak, Dr. Karolin Piechowiak, Philipps University Marburg Medical Center
• ClinicalTrials.gov Identifier: NCT02125903
• Other Study ID Numbers: AZ 06/13
• First Posted: Apr 29, 2014
• Last Update Posted: Jan 26, 2015
• Last Verified: Jan 1, 2015

• Additional relevant MeSH terms: Ropivacaine

Study Results

No Results Posted as of Jan 26, 2015