Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty

• ClinicalTrials.gov Identifier: NCT03143738
• Recruitment Status: Completed
• First Posted: May 8, 2017
• Last Update Posted: February 28, 2019
• Sponsor: Medical University of Lublin
• Collaborator: Konskie Specjalist Hospital
• Information provided by (Responsible Party): Michał Borys, Medical University of Lublin

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.

Condition or disease	Intervention/treatment	Phase
Pain, Acute; Knee Arthropathy; Postoperative Pain; Mobility Limitation	Procedure: continuous anesthesia of adductor canal; Procedure: continuous anesthesia of femoral nerve; Procedure: Spinal anesthesia	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two groups of patients randomly allocated: adductor canal group or femoral nerve group
• Masking: Single (Participant)
• Masking Description: Participants not aware of the type of continuous blockade.
• Primary Purpose: Treatment
• Official Title: Continuous Adductor Canal Block in Comparison to Continuous Femoral Nerve Block in Patients After Total Knee Arthroplasty: Randomized Control Trail
• Actual Study Start Date: April 24, 2017
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: July 26, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: continuous anesthesia of adductor canal	Procedure: continuous anesthesia of adductor canal; 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.; Procedure: Spinal anesthesia; 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 Name: Subarachnoid anesthesia
Experimental: continuous anesthesia of femoral nerve	Procedure: continuous anesthesia of femoral nerve; 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.; Procedure: Spinal anesthesia; 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 Name: Subarachnoid anesthesia

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Poland

Michał Borys

Lublin, Poland, 20-081

Sponsors and Collaborators

Medical University of Lublin

Konskie Specjalist Hospital

Investigators

• Principal Investigator: Michał Borys, M.D., PhD; Medical University of Lublin

More Information

• Responsible Party: Michał Borys, associate professor, Medical University of Lublin
• ClinicalTrials.gov Identifier: NCT03143738
• Other Study ID Numbers: KE-0254/188/2016
• First Posted: May 8, 2017
• Last Update Posted: February 28, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Michał Borys, Medical University of Lublin:

regional anesthesia; knee replacement; pain treatment; rehabilitation

Additional relevant MeSH terms:

Acute Pain; Mobility Limitation; Pain; Neurologic Manifestations; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs