NCT01122745

Brief Summary

  1. 1.Rotator cuff have painful post surgery recovery.
  2. 2.Single shot interscalene with oral analgesics may or may not be enough
  3. 3.Continuous nerve block may be too much for the surgery
  4. 4.The idea is to compare two techniques to see if the two techniques can improve patient pain control and satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Typical duration 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
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

3.2 years

First QC Date

May 11, 2010

Last Update Submit

May 29, 2014

Conditions

Keywords

continuous blocksingle shotinterscalenerotator cuff surgery

Outcome Measures

Primary Outcomes (1)

  • pain relief

    Patients having rotator cuff repair surgery will be randomized to either single shot or continuous catheter group. Pain score will be followed for 2 days to see which group gets better pain relief.

    2-3 days

Study Arms (2)

Catheter Group

Patient will have continuous interscalene block for pain relief placed preoperatively. They will go home with the portable pump. Pain score will be tracked via phone and compared with the control or single short group.

Single shot group

Patient will have single shot interscalene block and will go home. Pain will be tracked using phone. Pain will be compared with the catheter group.

Eligibility Criteria

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

All pateint undergoing arthroscopic rotator cuff surgrey and agreed to have regional block for pain control

You may qualify if:

  • adult
  • rotator cuff surgery
  • agreeing to regional block for pain control

You may not qualify if:

  • pregnancy
  • neuropathy
  • any allergies to local anesthetics
  • any contraindication to nerve blocks

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 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

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations