Clinical trial NCT03143738: Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty
Official title: Continuous Adductor Canal Block in Comparison to Continuous Femoral Nerve Block in Patients After Total Knee Arthroplasty: Randomized Control Trail
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Knee Arthropathy
Postoperative Pain
Mobility Limitation
Keywords: regional anesthesia
knee replacement
pain treatment
rehabilitation
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Konskie Specjalist Hospital
First posted: 2017-05-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of patients randomly allocated: adductor canal group or femoral nerve group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hours from the end of surgery
Secondary outcomes:
measure: Knee flexion
timeFrame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
measure: Walking
timeFrame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
measure: The change of acute postoperative pain
timeFrame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
measure: Sitting
timeFrame: 8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Michał Borys
Study officials:
affiliation: Medical University of Lublin
name: Michał Borys, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References: