Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty
Primary Purpose
Pain, Acute, Knee Arthropathy, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
continuous anesthesia of adductor canal
continuous anesthesia of femoral nerve
Spinal anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring regional anesthesia, knee replacement, pain treatment, rehabilitation
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
Sites / Locations
- Michał Borys
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
continuous anesthesia of adductor canal
continuous anesthesia of femoral nerve
Arm Description
Outcomes
Primary Outcome Measures
Morphine consumption
Total consumption of intravenous morphine by patients with the use of patient-controlled analgesia pump
Secondary Outcome Measures
Knee flexion
range of flexion in operated knee
Walking
Possibility of walking by patients at scheduled time points
The change of acute postoperative pain
Measured with VAS (visual-analogue scale)
Sitting
Possibility of walking by patients at scheduled time points
Full Information
NCT ID
NCT03143738
First Posted
May 3, 2017
Last Updated
February 27, 2019
Sponsor
Medical University of Lublin
Collaborators
Konskie Specjalist Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03143738
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 24, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
July 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Lublin
Collaborators
Konskie Specjalist Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute, Knee Arthropathy, Postoperative Pain, Mobility Limitation
Keywords
regional anesthesia, knee replacement, pain treatment, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of patients randomly allocated: adductor canal group or femoral nerve group
Masking
Participant
Masking Description
Participants not aware of the type of continuous blockade.
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
continuous anesthesia of adductor canal
Arm Type
Experimental
Arm Title
continuous anesthesia of femoral nerve
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
continuous anesthesia of adductor canal
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
continuous anesthesia of femoral nerve
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia
Other Intervention Name(s)
Subarachnoid anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Total consumption of intravenous morphine by patients with the use of patient-controlled analgesia pump
Time Frame
24 hours from the end of surgery
Secondary Outcome Measure Information:
Title
Knee flexion
Description
range of flexion in operated knee
Time Frame
8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Title
Walking
Description
Possibility of walking by patients at scheduled time points
Time Frame
8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Title
The change of acute postoperative pain
Description
Measured with VAS (visual-analogue scale)
Time Frame
8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
Title
Sitting
Description
Possibility of walking by patients at scheduled time points
Time Frame
8, 24, 48 hours from the end of surgery, and at the patient discharge from the hospital (an average 4-6 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michał Borys, M.D., PhD
Organizational Affiliation
Medical University of Lublin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michał Borys
City
Lublin
ZIP/Postal Code
20-081
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty
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