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

NCT02125903 | Completed

• 1 other identifier: AZ 06/13
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain Scores

  6, 24, 48, 72 hours postoperative

• Quadriceps strength

  6, 24, 28, 72 hours postoperative

• Ropivacaine consumption (each catheter)

  24, 48, 72 hours postoperative

• CAS (Cumulated Ambulation Score)

  24,48,72 hours postoperative

• Mobility Score (MoSc)

  24,48,72 hours postoperative

Study Arms (2)

Continuous Adductor Canal Block (CACB)

ACTIVE COMPARATOR

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

Continuous Femoral Nerve Block (CFNB)

ACTIVE COMPARATOR

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

Interventions

Ropivacaine DRUG

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

Continuous Adductor Canal Block (CACB); Continuous Femoral Nerve Block (CFNB)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philipps University Marburg: lead

Study Sites (1)

University of Marburg Department of Anaesthesia And Intensive Care Medicine

Marburg, 35037, Germany

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Karolin Piechowiak

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: April 29, 2014
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

DE (1)