NCT02431858

Brief Summary

To randomize 108 patients undergoing knee replacement surgery to catheter through needle or catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if there is a difference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2015

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

April 22, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

April 22, 2015

Last Update Submit

April 18, 2016

Conditions

Nerve BlockCatheterization

Keywords

Nerve blockCatheterCatheter over needleFemoral NerveAnaesthesia[E04.525.210.550][E02.148]

Outcome Measures

Primary Outcomes (1)

  • Catheter leakage

    Any leakage around the catheter insertion site as assessed by visual inspection.

    2 days post insertion

Secondary Outcomes (3)

  • Overall rate of secondary failure as assessed by the acute pain service on days 1 and 2 post op.

    2 days

  • Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale.

    intraoperative

  • Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.

    intraoperative

Study Arms (2)

Catheter Over Needle

EXPERIMENTAL

The femoral nerve catheter used will be the "E-Catheter" (Pajunk) device which is a novel catheter over needle system.

Device: E-Catheter (Pajunk)

Catheter through needle

ACTIVE COMPARATOR

The femoral nerve catheter used will be the "Sonolong" catheter (Pajunk) which is a traditional catheter through needle system.

Device: Sonolong Catheter (Pajunk)

Interventions

E-Catheter (Pajunk)DEVICE
Also known as: Australian Therapeutic Goods Registry (ATGR) no: 133630
Catheter Over Needle
Sonolong Catheter (Pajunk)DEVICE
Also known as: Australian Therapeutic Goods Registry (ATGR) no: 133630
Catheter through needle

Eligibility Criteria

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

You may qualify if:

  • Patients presenting to Sir Charles Gairdner Hospital for elective, unilateral, primary total knee replacement.
  • Body mass index 18-40 kg/m2
  • American Society of Anaesthetists (ASA) grade I-III

You may not qualify if:

  • Allergy to local anaesthetic
  • Inability to cooperate
  • Inability to read, speak and understand English
  • Less than 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Study Officials

  • Richard M Edwards, MBBS

    Sir Charles Gairdner Hospital

    PRINCIPAL INVESTIGATOR

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
Principle Investigator

Study Record Dates

First Submitted

April 22, 2015

First Posted

May 1, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

AU(1)