NCT02164825

Brief Summary

Single-shot femoral nerve block is similar to continuous epidural technique for postoperative analgesia in total knee arthroplasty

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

January 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 5, 2015

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

June 5, 2014

Last Update Submit

February 4, 2015

Conditions

Postoperative Pain Treatment for Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Pain Score on the numeric pain score

    Patients will be evaluated at 48 hours. At these time frame pain score at rest and during movement will be accessed.

    48 hours

Secondary Outcomes (3)

  • Side effects as a measure of safety and tolerability

    48 hours

  • Rescue analgesic consumption.

    48 hours

  • Patients satisfaction.

    48 hours

Study Arms (2)

Single-shot nerve block

EXPERIMENTAL

Efficacy compared to epidural

Drug: Ropivacaine perineural injection

Continuous epidural

ACTIVE COMPARATOR

Continuous epidural perfusion

Drug: morphine and ropivacaine

Interventions

Ropivacaine perineural injectionDRUG

Ultrasound guided single-shot femoral nerve block

Single-shot nerve block
morphine and ropivacaineDRUG

Continuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine.

Continuous epidural

Eligibility Criteria

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

You may qualify if:

  • Elective total knee arthroplasty

You may not qualify if:

  • Coagulopathy
  • Neuropathy
  • Morbid obesity
  • local anesthetics allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Tâmega e Sousa

Penafiel, Penafiel, 4564-007, Portugal

Location

MeSH Terms

Interventions

MorphineRopivacaine

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

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
MD

Study Record Dates

First Submitted

June 5, 2014

First Posted

June 17, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

February 5, 2015

Record last verified: 2014-06

Locations

PT(1)