NCT02082067

Brief Summary

Aim of this study is to evaluate the effects of the adductor canal block on the early and medium term ( 1 month) rehabilitation compared to the continuous femoral block commonly used in the knee prosthesis.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

1.5 years

First QC Date

February 28, 2014

Last Update Submit

August 8, 2016

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Up and Go test

    Knee functional evaluation at 5th postoperative day. "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair

    5th postoperative day

Secondary Outcomes (5)

  • VAS score

    up to POD5

  • Morphine request

    up to POD5

  • Range of motion

    5th postoperative day

  • Falling risk

    5th postoperative day

  • Quadriceps strength

    5th postoperative day

Study Arms (3)

Adductor canal

EXPERIMENTAL

All patients in the arm will receive continuous adductor canal block under ultrasound guidance. 10ml of Ropivacaine 0,75%, BBraun, Germany, will be injected to dilate adductor canal. After catheter insertion 10ml of Ropivacaine 0,75% will be injected.

Procedure: Adductor canalProcedure: Spinal AnesthesiaProcedure: Local anesthetic infusionProcedure: Intravenous analgesiaDrug: Ropivacaine 0,75%Drug: Levobupivacaine 0,5%Drug: Levobupivacaine 0,125%Drug: Ketorolac 30mgDrug: MorphineDevice: stimulong sono, Pajunk, Germany

Femoral

ACTIVE COMPARATOR

All patients in the arm will receive continuous femoral nerve block under ultrasound guidance. Correct position of catheter will be check with injection of 20ml Ropivacaine 0,75% BBraun, Germany medial to femoral nerve.

Procedure: FemoralProcedure: Spinal AnesthesiaProcedure: Local anesthetic infusionProcedure: Intravenous analgesiaDrug: Ropivacaine 0,75%Drug: Levobupivacaine 0,5%Drug: Levobupivacaine 0,125%Drug: Ketorolac 30mgDrug: MorphineDevice: stimulong sono, Pajunk, Germany

Controls

PLACEBO COMPARATOR

No patients of this arm receive continuous nerve block. Intravenous opioids analgesia will be administered.

Procedure: Spinal AnesthesiaProcedure: Intravenous analgesiaDrug: Levobupivacaine 0,5%Drug: Ketorolac 30mgDrug: Morphine

Interventions

Adductor canalPROCEDURE

Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.

Adductor canal
FemoralPROCEDURE

Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.

Femoral
Spinal AnesthesiaPROCEDURE

Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.

Adductor canalControlsFemoral
Local anesthetic infusionPROCEDURE

Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.

Adductor canalFemoral
Intravenous analgesiaPROCEDURE

Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.

Adductor canalControlsFemoral
Ropivacaine 0,75%DRUG
Adductor canalFemoral
Levobupivacaine 0,5%DRUG
Adductor canalControlsFemoral
Levobupivacaine 0,125%DRUG
Adductor canalFemoral
Ketorolac 30mgDRUG
Adductor canalControlsFemoral
MorphineDRUG
Adductor canalControlsFemoral
stimulong sono, Pajunk, GermanyDEVICE
Adductor canalFemoral

Eligibility Criteria

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

You may qualify if:

  • patients undergoing total knee arthroplasty

You may not qualify if:

  • diabetes
  • neurological disorders
  • coagulation disorders
  • rheumatoid arthritis
  • chronic opioids therapy
  • allergy to local anesthetic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto ortopedico Gaetano Pini

Milan, Italy

Location

MeSH Terms

Interventions

Anesthesia, SpinalKetorolacMorphine

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Gianluca Cappelleri, M.D.

    ASST Gaetano Pini-CTO

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 10, 2014

Study Start

March 1, 2014

Primary Completion

September 1, 2015

Study Completion

March 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

IT(1)