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Completed

NCT Number: NCT02125903

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

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

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Key information

Conditions

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

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Marburg Department of Anaesthesia And Intensive Care Medicine

Marburg, 35037, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

Primary outcomes

  1. Timed-Up and Go-test for mobility evaluation

    Time frame: 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 outcomes

  1. Pain Scores

    Time frame: 6, 24, 48, 72 hours postoperative

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

  2. Quadriceps strength

    Time frame: 6, 24, 28, 72 hours postoperative

    Numeric Scale (0-5)

  3. Ropivacaine consumption (each catheter)

    Time frame: 24, 48, 72 hours postoperative

    Measurement of the total amount

  4. CAS (Cumulated Ambulation Score)

    Time frame: 24,48,72 hours postoperative

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

  5. Mobility Score (MoSc)

    Time frame: 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

    Time frame: preop and 0, 6 , 24, 48, 48 hours postoperative

    Documentation of analgesic prescriptions and rescue medications during postoperative course

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2014
Registry last updated
Jan 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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