NCT02136446

Brief Summary

Patients scheduled for mastectomy and suitable for paravertebral block will be randomized to one of 2 groups. Group 1 will have the nerve block performed using a standard non-echogenic needle and catheter under ultrasound guidance. Group 2 will have the block performed using the control needle and an echogenic catheter, all under ultrasound (US) guidance. The clinician will be blinded to the catheter type and will assess the quality of catheter visualisation of the US image during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate and block quality. An assessment of the patient's pain levels after the procedure will also be conducted.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2014

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

First Submitted

Initial submission to the registry

May 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

May 7, 2014

Last Update Submit

May 18, 2015

Conditions

Peripheral Nerve Block Procedure

Keywords

Paravertebral blockMastectomyPost-operative painEchogenicPeripheral nerve block catheter

Outcome Measures

Primary Outcomes (2)

  • Visibility of entire catheter length

    Demonstrate superior ultrasound visibility of the entire length of the test catheter compared to the control, as graded by a blinded investigator

    Day 1, time of procedure

  • Visibility of catheter tip

    Demonstrate superior ultrasound visibility of the test catheter tip compared to the control, as graded by a blinded investigator

    Day 1, time of procedure

Secondary Outcomes (2)

  • Quality of the block

    Day 1, time of procedure

  • Block failure rate

    Day 1, time of procedure

Study Arms (2)

EchoGlo™ Peripheral Nerve Block Catheter

EXPERIMENTAL

Echogenic nerve block catheter (test)

Device: EchoGlo Nerve Block Catheter

Pajunk® EpiLong Catheter

ACTIVE COMPARATOR

Non-echogenic nerve block catheter (control)

Device: Pajunk® Nerve Block Catheter

Interventions

EchoGlo Nerve Block CatheterDEVICE

Catheter used for a paravertebral anesthesia block

Also known as: EchoGlo™ Peripheral Nerve Block Catheter
EchoGlo™ Peripheral Nerve Block Catheter
Pajunk® Nerve Block CatheterDEVICE

Nerve Block Catheter

Also known as: Pajunk® EpiLong Catheter
Pajunk® EpiLong Catheter

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled to undergo breast surgery requiring use of a peripheral nerve block catheter for establishing a paravertebral block
  • Patients classified as ASA (American Society of Anesthesiologists) physical status I, II or III
  • Patients at least 18 years old
  • Patient is willing and able to provide informed consent for study participation
  • Patient has a good understanding of written and verbal English

You may not qualify if:

  • Patient with contraindications to regional anesthesia technique (e.g. allergy to local anesthetic or other medications used in study)
  • Patient with known coagulopathy
  • Patient whose target nerve cannot be seen with linear ultrasound probe in a pre-procedure scan. All patients who need a curvilinear probe to visualize the target nerve will be excluded from the study.
  • Patients having mastectomy and immediate reconstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Hospital

London, NW14 5BU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Peter R Kratz, MS

    Smiths Medical

    STUDY DIRECTOR

Central Study Contacts

Simeon West, MBChB FRCA

CONTACT

+07919205965simeon.west@nhs.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 13, 2014

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-05

Locations

GB(1)