Comparison of Regional Anesthesia Techniques After Total Knee Arthroplasty

NCT ID: NCT03143738

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2018-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain, Acute Knee Arthropathy Postoperative Pain Mobility Limitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of patients randomly allocated: adductor canal group or femoral nerve group
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Participants not aware of the type of continuous blockade.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

continuous anesthesia of adductor canal

Group Type EXPERIMENTAL

continuous anesthesia of adductor canal

Intervention Type 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.

Spinal anesthesia

Intervention Type 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.

continuous anesthesia of femoral nerve

Group Type EXPERIMENTAL

continuous anesthesia of femoral nerve

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Subarachnoid anesthesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Konskie Specjalist Hospital

UNKNOWN

Sponsor Role collaborator

Medical University of Lublin

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michał Borys

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michał Borys, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Lublin

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Michał Borys

Lublin, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KE-0254/188/2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Adductor Canal Block
NCT04513145 ACTIVE_NOT_RECRUITING PHASE2/PHASE3