NCT03143738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

May 3, 2017

Last Update Submit

February 27, 2019

Conditions

Pain, AcuteKnee ArthropathyPostoperative PainMobility Limitation

Keywords

regional anesthesiaknee replacementpain treatmentrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

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

    24 hours from the end of surgery

Secondary Outcomes (4)

  • Knee flexion

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

  • Walking

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

  • The change of acute postoperative pain

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

  • Sitting

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

Study Arms (2)

continuous anesthesia of adductor canal

EXPERIMENTAL
Procedure: continuous anesthesia of adductor canalProcedure: Spinal anesthesia

continuous anesthesia of femoral nerve

EXPERIMENTAL
Procedure: continuous anesthesia of femoral nerveProcedure: Spinal anesthesia

Interventions

continuous anesthesia of adductor canalPROCEDURE

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 adductor canal
continuous anesthesia of femoral nervePROCEDURE

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.

continuous anesthesia of femoral nerve
Spinal anesthesiaPROCEDURE

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.

Also known as: Subarachnoid anesthesia
continuous anesthesia of adductor canalcontinuous anesthesia of femoral nerve

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee arthroplasty
  • obtained consent
  • subarachnoid anaesthesia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michał Borys

Lublin, 20-081, Poland

Location

MeSH Terms

Conditions

Acute PainPain, PostoperativeMobility LimitationAgnosia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Michał Borys, M.D., PhD

    Medical University of Lublin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants not aware of the type of continuous blockade.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups of patients randomly allocated: adductor canal group or femoral nerve group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 3, 2017

First Posted

May 8, 2017

Study Start

April 24, 2017

Primary Completion

June 30, 2018

Study Completion

July 26, 2018

Last Updated

February 28, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)