NCT01696188

Brief Summary

This is a randomized, double-blinded, prospective study designed to compare two approaches (in the plane of the ultrasound beam and out of the plane of the ultrasound beam) to placing an interscalene nerve block and catheter for pain control after open shoulder surgery. Both approaches have been used successfully but neither has been proven to be superior. Our endpoints are pain scores, time for block placement, and catheter dislodgements. We hypothesized that patients with the out-of-plane approach would have decreased pain and fewer catheter dislodgements.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2012

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 16, 2015

Completed
Last Updated

November 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

September 13, 2012

Results QC Date

August 4, 2015

Last Update Submit

October 14, 2015

Conditions

Shoulder Pain

Keywords

Interscalenenerve blocknerve catheterin-planeout-of-planeanterolateral approachposterior approachshoulder surgery

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale Pain Scores

    Pain was rated from 0 (no pain) to 10 (worst pain imaginable)

    24 hours

Secondary Outcomes (3)

  • Catheter Dislodgements

    24 hours

  • Opioid Consumption

    48 hours

  • Time for Block Placement

    immediately post-procedure

Study Arms (2)

In-plane group

EXPERIMENTAL

This group will receive an interscalene catheter placed with in-plane approach.

Device: interscalene nerve catheter

Out-of-plane group

EXPERIMENTAL

This group will receive an interscalene catheter with an out-of-plan approach.

Device: interscalene nerve catheter

Interventions

interscalene nerve catheterDEVICE
Also known as: Peripheral nerve catheter kit, B Braun (Bethlehem, PA)
In-plane groupOut-of-plane group

Eligibility Criteria

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

You may qualify if:

  • speaks English

You may not qualify if:

  • children,
  • neuropathy in operative arm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

  • Fredrickson MJ, Ball CM, Dalgleish AJ. Posterior versus anterolateral approach interscalene catheter placement: a prospective randomized trial. Reg Anesth Pain Med. 2011 Mar-Apr;36(2):125-33. doi: 10.1097/aap.0b013e31820d5ee6.

    PMID: 21425511BACKGROUND

  • Antonakakis JG, Sites BD, Shiffrin J. Ultrasound-guided posterior approach for the placement of a continuous interscalene catheter. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):64-8. doi: 10.1016/AAP.0b013e3181933a53.

    PMID: 19258990BACKGROUND

  • Mariano ER, Loland VJ, Ilfeld BM. Interscalene perineural catheter placement using an ultrasound-guided posterior approach. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):60-3. doi: 10.1097/AAP.0b013e3181933af7.

    PMID: 19258989BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Eric Schwenk
Organization
Sidney Kimmel Medical College at Thomas Jefferson University
Eric.Schwenk@jefferson.edu
215-955-6161

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 28, 2012

Study Start

July 1, 2012

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 16, 2015

Results First Posted

November 16, 2015

Record last verified: 2015-10

Locations

US(1)