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Completed

NCT Number: NCT03143738

Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty

Comparison of continuous adductor canal block to continuous femoral nerve block in patients after total knee arthroplasty.

All patients will be anesthetized with spinal anesthesia. Continuous infusion of ropivacaine with a catheter implemented to the adductor canal or next to the femoral nerve.

The observed goals: pain intensity, the beginning and quality of rehabilitation.

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Key information

Conditions

Pain, Acute Acute Pain Agnosia Knee Arthropathy Mobility Limitation Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michał Borys

Lublin, 20-081, Poland

About this study

Written consent will be obtained a day before the surgery. Only subarachnoidally anaesthetised patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.

Before the beginning of operation, under ultrasound control, a catheter will be implemented to one of the chosen position: the adductor canal (the middle or lower third of thigh) or near the femoral nerve (below the inguinal ligament). The local anesthetic solution of 0.2 % ropivacaine will be started with an elastomeric pump (5 mL per hour, up to 72 hours) as soon as a catheter in the right position.

The pain will be measured with VAS (visual-analogue scale) 8, 24 and 48 hours after the end of operation, and at the discharge. At the same time, i.e.: 8, 24 and 48 hours from the end of surgery, the range of flexion and extension in the operated knee will be assessed. Moreover, the possibility of patient's sitting, standing up and walking will be noted.

All parameters will be reassessed before patients' discharge from the hospital. Each patient will receive paracetamol (1.0) and metamizol (1.0) intravenously (i.v.) q6h. 5 mg of morphine may be given as required, up to 2 dosages per day as a rescue medication.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • knee arthroplasty
  • obtained consent
  • subarachnoid anaesthesia

Exclusion criteria

  • coagulopathy
  • allergy to to local anesthetics
  • depression, antidepressant drugs treatment
  • epilepsy
  • usage of painkiller before surgery
  • addiction to alcohol or recreational drugs

Treatment and study plan

continuous anesthesia of adductor canal

Procedure

After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented to the adductor canal and infusion of 5 mL/h of 0.2 % ropivacaine will be started.

continuous anesthesia of femoral nerve

Procedure

After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented next to the femoral nerve (below inguinal ligament) and infusion of 5 mL/h of 0.2 % ropivacaine will be started.

Spinal anesthesia

Procedure

Before the beginning of surgery all patients will be anesthetised with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 2.0 - 2.5 mL solution. Pencil point spinal needle will be used.

Other names: Subarachnoid anesthesia

Primary outcomes

  1. Morphine consumption

    Time frame: 24 hours from the end of surgery

    Total consumption of intravenous morphine by patients with the use of patient-controlled analgesia pump

Secondary outcomes

  1. Knee flexion

    Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)

    range of flexion in operated knee

  2. Walking

    Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)

    Possibility of walking by patients at scheduled time points

  3. The change of acute postoperative pain

    Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)

    Measured with VAS (visual-analogue scale)

  4. Sitting

    Time frame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)

    Possibility of walking by patients at scheduled time points

Sponsors and collaborators

Lead sponsor

Medical University of Lublin

Other

Collaborators

  • Konskie Specjalist Hospital

Registry information

Official study title

Continuous Adductor Canal Block in Comparison to Continuous Femoral Nerve Block in Patients After Total Knee Arthroplasty: Randomized Control Trail

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 8, 2017
Registry last updated
Feb 28, 2019

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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