NCT01122732

Brief Summary

  1. 1.Interscalene continuous catheter is a very effective way of controlling pain in total shoulder arthroplasty. To ensure proper placement, nerve stimulating catheter is quite often used.
  2. 2.Ultrasound can help proper placement of catheter without relying on nerve stimulation.
  3. 3.The plan of the study is to compare two techniques head to head to see if they are equally effective or one is better than others.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

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

May 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

5.1 years

First QC Date

May 11, 2010

Last Update Submit

October 31, 2016

Conditions

Keywords

nerve blockcontinuous cathetershoulder surgerypain control after total shoulder arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain will be monitored over the next 2-3 days while subjects have catheter inplace. Sleep, total oral analgesic intake will be compared.

    2-3 days after surgery

Study Arms (2)

US Group

Interscalene catheter will be placed with US guidance without any nerve stimulation guidance.

NS Group

Catheter will be placed using nerve stimulation guidance

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all subjects having total shoulder arthroplasty.

You may qualify if:

  • yr or older
  • patient agreed to continuous regional block

You may not qualify if:

  • minor
  • patient refusal
  • any neuropathy
  • allergies to local anesthetic,
  • inability to obtain informed consent for any reason, Opioid user, chronic pain patients or unanticipated procedure other than total shoulder arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Hospitals

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • TARIQ MALIK, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2010

First Posted

May 13, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations