NCT01755117

Brief Summary

Total Knee Replacement can be performed under the combination of posterior lumbar plexus block plus sciatic nerve block. The investigators can have the same outcome by performing instead of posterior lumbar plexus block more peripheral nerve blocks. More specifically under the combination of sciatic nerve block plus femoral nerve block plus obturator nerve block.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

April 29, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

December 18, 2012

Last Update Submit

April 27, 2014

Conditions

Total Knee ReplacementSurgery

Outcome Measures

Primary Outcomes (1)

  • Feasibility of TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block measured with Pain Score on the Visual Analog Scale

    If the patient complains for pain \> 4 in VAS and there is no relief with fentanyl administration the anesthesia plan converts to general anesthesia with laryngeal mask

    Completion of surgery

Secondary Outcomes (1)

  • Intraoperative opioid consumption for TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block

    Intaoperatively

Other Outcomes (1)

  • Postoperative opioid consumption

    First 24 postoperative hours

Study Arms (2)

TKR, sciatic, femoral, obturator

ACTIVE COMPARATOR

TKR surgery under ultrasound guided sciatic nerve block plus femoral nerve block plus obturator nerve block

Other: Sciatic, femoral, obturator nerve blocks

TKR sciatic nerve block, posterior lumbar plexus block

ACTIVE COMPARATOR

TKR surgery under ultrasound guided sciatic nerve block plus posterior lumbar plexus block

Other: Sciatic nerve block, posterior lumbar plexus block

Interventions

Sciatic, femoral, obturator nerve blocksOTHER
Also known as: Ultrasound guided blocks with ropivacaine
TKR, sciatic, femoral, obturator
Sciatic nerve block, posterior lumbar plexus blockOTHER
Also known as: Ultrasound guided blocks with ropivacaine
TKR sciatic nerve block, posterior lumbar plexus block

Eligibility Criteria

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

You may qualify if:

  • Age 18 - 80 yrs
  • ASA I - III
  • TKR surgery

You may not qualify if:

  • Coagulopathy disorders
  • Infection at the puncture site for the interscalene block
  • Neurologic deficit in the arm that is going to be operated
  • Allergy to local anesthetics
  • BMI \> 35
  • Psychiatric disorders
  • Patient's refusal
  • Problems with patient communication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Larissa University Hospital

Larissa, Thessally, 41110, Greece

RECRUITING

Related Publications (1)

  • Enneking FK, Chan V, Greger J, Hadzic A, Lang SA, Horlocker TT. Lower-extremity peripheral nerve blockade: essentials of our current understanding. Reg Anesth Pain Med. 2005 Jan-Feb;30(1):4-35. doi: 10.1016/j.rapm.2004.10.002. No abstract available.

    PMID: 15690265BACKGROUND

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Marina Simaioforidou, Medicine

    Larissa University Hospital

    PRINCIPAL INVESTIGATOR

  • Metaxia Bareka, Medicine

    Larissa University Hospital

    STUDY CHAIR

  • George Basdekis, Medicine

    Larissa University Hospital

    STUDY CHAIR

  • Athanasios Drakos, Medicine

    Larissa University Hospital

    STUDY CHAIR

  • Aristeidis Zibis, Medicine

    Private Clinic of Larissa Asklipeiio

    STUDY CHAIR

  • Konstantinos Alexiou, Medicine

    Larissa University Hospital

    STUDY CHAIR

Central Study Contacts

Metaxia Bareka, Medicine

CONTACT

00306947845083barekametaxia@hotmail.com

Marina Simaioforidou, Medicine

CONTACT

00306947845083msimaiof@otenet.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

December 18, 2012

First Posted

December 24, 2012

Study Start

December 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 29, 2014

Record last verified: 2014-04

Locations

GR(1)