NCT01843153

Brief Summary

The role of a sciatic block in addition to a femoral block remains controversial. The study addresses this topic by comparing a continuous block versus an injection on demand.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 25, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 31, 2015

Status Verified

April 1, 2013

Enrollment Period

1.5 years

First QC Date

April 25, 2013

Last Update Submit

March 30, 2015

Conditions

Total Knee ArthroplastyPain

Keywords

pain score

Outcome Measures

Primary Outcomes (1)

  • pain score (VRS)

    4 days

Secondary Outcomes (1)

  • frequency of injections into the sciatic catheter

    4 days

Study Arms (2)

intermittent

OTHER

injection of ropivacaine on demand

Drug: Ropivacaine

continuous

OTHER

continuous ropivacaine infusion

Drug: Ropivacaine

Interventions

RopivacaineDRUG
continuousintermittent

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for total knee arthroplasty

You may not qualify if:

  • failure to establish femoral and sciatic block
  • insufficient analgesic effect of the block
  • patient declines to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKH Dormagen

Dormagen, D-51375, Germany

Location

Related Publications (1)

  • Soltesz S, Meiger D, Milles-Thieme S, Saxler G, Ziegeler S. Intermittent versus continuous sciatic block combined with femoral block for patients undergoing knee arthroplasty. A randomized controlled trial. Int Orthop. 2016 Sep;40(9):1861-7. doi: 10.1007/s00264-016-3117-3. Epub 2016 Jan 25.

    PMID: 26810904DERIVED

MeSH Terms

Conditions

Pain

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2013

First Posted

April 30, 2013

Study Start

April 1, 2013

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

March 31, 2015

Record last verified: 2013-04

Locations

DE(1)